medical device dailytm the daily medical technology news source

Transcription

MEDICAL DEVICE DAILY
TM
THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE
WEDNESDAY, MARCH 18 , 2015
VOLUME 19, NO. 53
AMERICAN COLLEGE OF CARDIOLOGY SCIENTIFIC SESSIONS 2015
Popma needles Zuckerman to approve Survival solid in two-year CoreValve
Edwards’ Sapien 3 with 30-day data data, but pacemaker, leak issues persist
By Mark McCarty, Washington Editor
SAN DIEGO — FDA and practicing physicians might not seem
to have a naturally adversarial relationship, but a cardiologist
of some repute called out FDA on the second day of the 2015
scientific sessions
ACC15 notebook, p. 4
held
by
the
American College
of Cardiology (ACC; Washington). Jeff Popma of Beth Israel
Deaconess (Boston), a cardiologist of some repute, attempted
to light a fire under FDA’s Office of Device Evaluation after a
presentation of 30-day data for the third-generation Sapien
See Edwards, page 7
SAN DIEGO — Transcatheter aortic valve replacement
(TAVR) is not exactly a mature medical technology, a message
that might have come across in a presentation at ACC 2015 here
in sunny San Diego. Michael Reardon of Houston Methodist
Hospital (Houston) reported on two-year data for high-risk
patients for the Medtronic (Dublin) CoreValve, and while the
survival numbers increasingly favored the device over surgical
valve replacement, the issues of paravalvular leak and postprocedural implant of pacemakers continue to dog this device
category for more than one player.
See Medtronic, page 8
Keystone Heart’s TriGuard lowers
risk of stroke for TAVR patients
U-Lite brings diagnostic
ultrasound to hand-held tablet
By Omar Ford, Staff Writer
By John Brosky, Europe Editor
The stars seem to be aligning for Keystone Heart’s (Caeserea,
Israel) TriGuard embolic protection device. Researchers revealed
results of an evaluation of the device in the DEFLECT III trial,
at the American College of Cardiology (Washington) annual
meeting held in San Diego this week. In the multi-center trial,
Yale School of Medicine (New Haven, Connecticut) researchers
tested TriGuard, which is said to lower the risk of stroke and
cognitive decline in patients undergoing Transcatheter Aortic
Valve Replacement (TAVR) procedures.
In the DEFLECT III trial – which evaluated 83 patients
across 13 centers in five nations – all the patients on Edwards
Lifescience’s (Irvine, California) Sapien had no ischemic brain
See Keystone, page 9
PARIS — Perhaps we thought this was already done. Didn’t
someone put an ultrasound scanner in the pocket of a doctor’s
white lab coat for instant, point-of-care (POC) diagnosis and
consultation? Didn’t this conversion signaled the end for the oldstyle stethoscope, replacing it with an all-seeing, digital version?
Well, yes and no. It seems the death of the stethoscope had
been greatly exaggerated.
And judging by the interest of every major ultrasound
company in the new tablet-sized U-Lite from Sonoscanner
(Paris), there is plenty of opportunity to expand this market
segment that is expected to reach $1.2 billion by 2016 in the
U.S., according to a widely-cited report from iData Research
See U-Light, page 10
ONCOLOGY EXTRA
INSIDE
BD COMPLETES ITS $12.2 B
ACQUISITION OF CAREFUSION
VARIAN ESTABLISHES LOCAL
OPERATING ENTITY IN ALGERIA
PAGE 2
PAGE 3
Washington Editor Mark McCarty
on one of med-tech’s key sectors
For Sales Inquiries: http://ip-science.interest.thomsonreuters.com/Bioworld_Sales_Inquiry. NORTH AMERICA,
Tel: +1 855 260 5607. Outside of the U.S. and Canada, Tel. +44.203.684.1797. For Customer Service Inquiries,
NORTH AMERICA, Tel: +1-800-336-4474. Outside of the U.S. and Canada, Tel. +44-203-684-1796.
Or email [email protected]. Copyright ©Thomson Reuters.
Reproduction is strictly prohibited. Visit our website at www.medicaldevicedaily.com
Read this week’s Wednesday Special
MEDICAL DEVICE DAILY™ PAGE 2 OF 10
DAILY M&A
BD completes its $12.2 B
acquisition of CareFusion
Staff Report
Becton, Dickinson and Company (BD; Franklin Lakes, New
Jersey) said that it completed its acquisition of CareFusion (San
Diego) for $12.2 billion, pursuant to the terms of its previously
announced agreement and plan of merger (Medical Device Daily,
Oct. 7, 2014).
CareFusion shareholders received $49 in cash and 0.0777 of
a share of BD for each share of CareFusion, or a total of $58 per
CareFusion share based on BD’s closing price as of Oct. 3, 2014.
Vincent Forlenza, BD’s chairman/president/CEO, said,
“We are very excited to announce the consummation of the
CareFusion acquisition, as it represents a major milestone in BD’s
118-year history. This acquisition significantly accelerates BD’s
strategy and builds scale and depth in medication management
and patient safety solutions. We look forward to the future with
confidence as we become one of the largest global leaders in
medical technology, and are better positioned to partner with
healthcare providers around the world to provide safer, more
economical and improved care.”
The transaction is expected to provide double-digit cash
See M&A, page 9
MEDICAL DEVICE DAILY
Medical Device Daily™ (ISSN# 1541-0617) is published every business day by
U.S. and Canada, Tel. +44.203.684.1797. For Customer Service Inquiries,
NORTH AMERICA, Tel: +1-800-336-4474. Outside of the U.S. and Canada,
Tel. +44-203-684-1796. Or email [email protected].
Copyright ©Thomson Reuters. Reproduction is strictly prohibited. Visit our
Thomson Reuters, 115 Perimeter Center Place, Suite 1100, Atlanta, GA 30346
website at www.medicaldevicedaily.com.
U.S.A. Opinions expressed are not necessarily those of this publication.
For ad rates and information, please contact Tyler Beatty toll free at (855)
Mention of products or services does not constitute endorsement. All Rights
260-5607; outside the U.S. and Canada, call (646) 822-4549 or by email at
Reserved. No part of this publication may be reproduced without the written
[email protected].
consent of Thomson Reuters (GST Registration Number R128870672).
For photocopy rights or reprints, please contact Tyler Beatty toll free at (855)
CONTACT US
[email protected]
Donald R. Johnston, (770) 810 3118 // Holland Johnson, (770) 810-3122 //
Amanda Pedersen, (912) 660-2282 // Omar Ford, (770) 810-3125 // Robert
260-5607; outside the U.S. and Canada, call (646) 822-4549 or by email at
[email protected].
Send all press releases and related information to
[email protected].
Kimball, (770) 810-3127 // Mark McCarty, (703) 361-2519 // Sarah Cross,
(770) 810-3138// Penney Holland (770) 810-3047 // Tracie Webb, (770) 8103130
OUR NEWSROOM
Holland Johnson (Executive Editor), Robert Kimball (Senior Production Editor),
Mark McCarty (Washington Editor), Omar Ford & Amanda Pedersen (Staff Writers)
PRACTICAL INFORMATION
For Sales Inquiries: http://ip-science.interest.thomsonreuters.com/Bioworld_Sales_Inquiry. NORTH AMERICA, Tel: +1 855 260 5607. Outside of the
BUSINESS OFFICE
Donald R. Johnston (Senior Director), Sarah Cross (Marketing Director),
Penney Holland (Web Production Manager), Tracie Webb (Customer Service
Manager)
MEDICAL DEVICE DAILY™ WORLD IN REVIEW
Varian establishes local
operating entity in Algeria
Staff Report
Varian Medical (Palo Alto, California), a maker of
radiotherapy systems and software for the treatment of cancer,
is expanding in North Africa with the creation of a strategic
operating entity in Algeria. Varian Medical Algeria SPA is the
result of a joint venture with Cialfarm S.A.R.L., a local healthcare
specialist.
“This move represents the next step in our commitment
both to the Algerian cancer program and the wider business
community,” said Burt Lang, Varian’s managing director in
Africa. “Cancer is growing rapidly in Africa and has become
one of the continent’s top healthcare concerns. Radiotherapy
plays a vital and cost effective role in treating cancer and we
are committed to making it available to more patients across
the continent.”
Varian Medical Systems Algeria represents a significant
investment in new offices, a training and education center,
a parts depot and a service center. “This partnership will
focus on enhancing access to care and patient outcomes,
providing clinical customers with a high level of service,
and the creation of educational programs to train clinicians
on the use of Varian technology to deliver advanced
radiotherapy,” said Fouad Rahal, managing director of
VMS Algeria SPA.
The first Varian linear accelerator was installed in Algeria
over 20 years ago and the company now has 16 systems operating
across the country. Recently, Varian treatment systems were
installed at government specialty cancer clinics in the cities of
Batna and Setif.
Last year, Varian reported that it had entered into an
agreement with the Algerian Ministry of Health to equip six
cancer treatment centers with $51 million dollars of advanced
technology for radiotherapy and radiosurgery. Those systems,
which will include advanced TrueBeam treatment devices, will
be installed as soon as the centers are constructed.
Varian Medical Systems focuses energy on saving lives
by equipping the world with advanced technology for fighting
cancer and for X-ray imaging.
PAGE 3 OF 10
groups traveling to Boston to access the ultrasensitive single
molecule protein detection technology in our Accelerator Lab,”
said Kevin Hrusovsky, executive chairman/CEO at Quanterix.
“We are thrilled to find a partner as strong as SCRUM to offer
researchers comprehensive sales, applications and field service
support locally in Japan.”
“SCRUM is extremely pleased to enter into this
partnership with Quanterix. We expect to develop and
maintain a mutually beneficial relationship with Quanterix
and rapidly engage the life science industry in Japan,” said
Mikio Fuchigami, president/CEO of SCRUM. “Simoa is a
revolutionary technology which has the world’s most sensitive
ELISA immunoassay. The system, the Simoa HD-1 Analyzer,
has already generated significant interest in the U.S. and
Europe, and dozens of instruments have been installed since
December 2013. We anticipate a similar response in Japan and
are keen for the opportunity to introduce the technology to
the automated ELISA market, providing Japanese researchers
with the most advanced technology for their biomarker work.
We will be making the first official introduction of the Simoa
HD-1 Analyzer in Japan at the American Embassy in Tokyo on
April 17th.”
SCRUM brings superior value from around the world to
the labs in pharmaceutical companies, diagnostic companies,
universities, national institutions and other commercial biotech
companies. //
www.ceamedmfg.com
Need
Infrastructure?
Contract Engineering & Manufacturing
of Final Packaged Critical Care Medical Devices
SINCE
1988
Quanterix names SCRUM for Simoa distribution in Japan
Quanterix (Lexington. Massachusetts), a maker of
high definition diagnostics, delivering ultrasensitive single
molecule measurement for the benefit of human health, has
appointed SCRUM (Tokyo), as an exclusive distributor for
sales and support of its Simoa technology for the research
market in Japan.
“We have experienced strong demand from researchers in
Japan for our Simoa technology with several Japanese researcher
Dedicated 100% to medical devices
Domestic and OUS manufacturing
Vertically integrated for component, sub-assembly, & final packaging
www.ceamedmfg.com
Call Marcus Boggs, CEO
(719) 591-5300
www.ceamedmfg.com
For Sales Inquiries: http://ip-science.interest.thomsonreuters.com/Bioworld_Sales_Inquiry. NORTH AMERICA, Tel: +1 855 260 5607. Outside of the U.S. and Canada, Tel. +44.203.684.1797. For Customer Service Inquiries, NORTH AMERICA, Tel: +1-800-336-4474. Outside of the U.S. and Canada, Tel.
+44-203-684-1796. Or email [email protected]. Copyright ©Thomson Reuters. Reproduction is strictly prohibited. Visit our website at
www.medicaldevicedaily.com
MEDICAL DEVICE DAILY™ ACC 2015 NOTEBOOK
CVRx reports positive results from
study of Barostim Therapy for HF
Staff Report
CVRx (Minneapolis) said that positive results from the
Barostim Therapy for Heart Failure randomized, controlled
clinical trial were presented at the American College of
Cardiology (ACC; Washington) meeting this week in San Diego.
Results were presented by William Abraham from The Ohio
State University (Columbus), who served on the trial’s steering
committee.
Abraham called the results encouraging and said that
Barostim proved to be safe and significantly improved patient
functional status, quality of life score, exercise capacity, serum
biomarkers of heart failure severity, and suggested that the
burden of heart failure hospitalizations may also be reduced with
Barostim therapy.
“The positive results from our randomized, controlled clinical
trial were well received at ACC,” said Nadim Yared, president/
CEO of CVRx. “The safety and effectiveness data presented
simultaneously with the online publication of the manuscript in
JACC-HF, will further support our commercial success in Europe.”
CVRx completed a 146 patient randomized, controlled
clinical trial to determine the performance of Barostim therapy
for patients suffering from chronic heart failure with advanced
symptoms. Promising results from an earlier study demonstrating
clinical improvement and reduced hospitalizations have been
presented and published.
Barostim neo is a second generation device that uses
technology designed to trigger the body’s own natural blood
flow regulation system to treat patients suffering from chronic
heart failure. The therapy is also a treatment option for patients
with resistant hypertension. The system works by electrically
activating the baroreceptors, the body’s natural sensors that
regulate cardiovascular function. By activating this afferent
pathway, Barostim restores sympatho-vagal balance by reducing
sympathetic activity and increasing parasympathetic activity.
The company noted that the Barostim neo can be turned
on and off to demonstrate acute results and that it can be
adjusted to meet each patient’s individual needs. It is also a
reversible treatment and is compatible with and complementary
to implantable cardiac rhythm management devices, CVRx said.
In other news from the ACC meeting:
• Biotronik (Lake Oswego, Oregon) presented clinical data
demonstrating the safety and efficacy of its ProMRI pacemaker.
William Bailey, medical director of Louisiana Heart Rhythm
Specialists (Lafayette, Louisiana) discussed these results at ACC.
At the ACC poster session Bailey reported that the ProMRI
pacemakers can safely be used in an MRI environment. They were
shown to be free of significant threshold increases, significant
decreases in amplitude and serious adverse effects one month
PAGE 4 OF 10
post-MRI. The ProMRI Phase B study enrolled 203 patients who
underwent full-body MRI scans, including cardiac and thoracic
spinal scans, without an exclusion zone.
“I am glad to present the latest in a growing body of data
that supports the safety and efficacy of ProMRI pacemakers in
the MRI environment,” said Bailey. “Pacing devices approved
for use with MRI scans will lead to crucial clinical benefits for
patients.”
Additional data showed that clinically useful diagnostic
image quality can be obtained when pacemaker patients undergo
cardiac or thoracic spine 1.5 tesla MRI scans. Researchers
analyzed the 203 MRI scans from the ProMRI Phase B study for
image artifacts, defined as any features that appear in an image
but are not present in the original imaged object. They found
that 96.1% of the images had no artifact or contained an artifact
which did not affect diagnostic image quality.
“We are pleased to share these study results as we move
through the final phases of our ProMRI study, including
pacemakers and ICDs,” said Kevin Mitchell, VP of clinical studies
at Biotronik. “Given the popularity and clinical benefits of MRI
scans, U.S. patients want greater access to this potentially lifesaving technology.”
• Researchers funded by the National Heart, Lung, and Blood
Institute (NHLBI) have determined that surgical cardiac ablation,
a widely used surgical technique for correcting abnormal heart
rhythm, is effective, but increases the likelihood that patients
will later need permanent pacemakers. The study included
260 patients with atrial fibrillation, the most common type of
irregular heart rhythm, who each had mitral-valve surgery at one
of 20 research centers in the U.S. and Canada.
The study results were presented at ACC and published
simultaneously in the New England Journal of Medicine.
Led by Marc Gillinov, surgical director of the Center for Atrial
Fibrillation at Cleveland Clinic, the study was conducted through
the Cardiothoracic Surgical Trials Network, which is supported by
the NHLBI and the National Institute of Neurological Disorders
and Stroke – both part of the National Institutes of Health – as
well as the Canadian Institutes of Health Research.
Surgical cardiac ablation involves using a probe to scar
small areas inside the heart that cause heart rhythm problems.
Surgeons routinely use this technique during heart operations
but, until now, its safety and effectiveness have not been
rigorously measured, according to the researchers. //
MDD is on Twitter!
Stay Connected. Follow Us on Twitter!
www.twitter.com/meddevicesdaily
MEDICAL DEVICE DAILY™ AGREEMENTS/CONTRACTS
Myriad, BioMarin expand
evaluation of myChoice HRD
Staff Writer
Myriad Genetics (Salt Lake City) reported an expansion of
the company’s collaboration with BioMarin Pharmaceutical
(Novato, California). Under the expanded collaboration,
BioMarin will use Myriad’s myChoice HRD companion diagnostic
test to prospectively identify patients with metastatic breast,
ovarian and potentially other tumor types that may be sensitive
to talazoparib. Financial terms were not disclosed.
Talazoparib is an investigational poly-ADP ribose
polymerase (PARP) inhibitor being developed by BioMarin. In
the expanded relationship, the companies also will collaborate
under FDA regulations and guidelines for the development and
potential regulatory approval requirements for both talazoparib
and myChoice HRD.
“Myriad is a pioneer in personalized medicine. Our companion
diagnostics are providing clinicians with valuable biological data
to accelerate and improve healthcare for their patients,” said Mark
Capone, president of Myriad Genetic Laboratories. “With cancer
treatments, there is no one-size-fits-all approach for patients.
We are excited to be working with BioMarin to help identify the
patients who are most likely to benefit from talazoparib based on
their own genetic makeup and biology.”
The expansion adds to an ongoing collaboration that
began in September 2013, when BioMarin began using Myriad’s
BRACAnalysis CDx companion diagnostic test in its pivotal
Phase 3 EMBRACA and Phase 2 ABRAZO clinical studies of
talazoparib for advanced or metastatic breast cancer patients
carrying BRCA mutations.
Myriad’s myChoice HRD is a homologous recombination
deficiency test that can detect when a tumor has lost the ability
to repair double-stranded DNA breaks, resulting in increased
susceptibility to DNA-damaging drugs such as platinum drugs
or PARP inhibitors. High myChoice HRD scores reflective of DNA
repair deficiencies are prevalent in all breast cancer subtypes,
ovarian and most other major cancers.
Myriad Genetics is a molecular diagnostic company
dedicated to making a difference in patients’ lives through the
discovery and commercialization of transformative tests to
assess a person’s risk of developing disease, guide treatment
decisions, and assess risk of disease progression and recurrence.
In other agreements/contracts news:
• HemCon Medical Technologies (Portland, Oregon), a
subsidiary of TriStar Wellness Solutions, and a developer and
marketer of advanced wound care products, said that HemCon
has joined aptitude (Irving, Texas), the healthcare industry’s
first direct contracting market. Today, aptitude has more than
1,000 hospitals that benefit from reducing the online platform
that reduces the contract cycle time by 50% by automating key
PAGE 5 OF 10
components of the process. HemCon has added its full product
line to aptitude and hopes to introduce new customers by using
the user friendly interface and quick turn around on contracts.
HemCon plans to continue to grow its portfolio online, which will
be beneficial to all current and prospective HemCon customers.
Adding an additional way to take its products to market supports
HemCon’s continuing expansion into the hospital market.
Michael Wax, CEO of HemCon, said, “We are pleased to
join aptitude and participate in their innovative cost reduction
supply model. The agreement to offer our products to hospitals
through aptitude was timely and fluid. We are confident that this
fast growing technology based platform will continue to grow
rapidly and help add to our market reach.”
HemCon Medical Technologies makes innovative
technologies for hemostatic devices for the control of bleeding
resulting from trauma or surgery.
TriStar Wellness Solutions is a health and wellness
company that targets opportunities in the advanced wound care
marketplace. As healthcare’s direct contracting market, aptitude
says it is meeting the evolving demands of today’s healthcare
organizations.
• Omnyx (Pittsburgh), the digital pathology joint venture
between University of Pittsburgh Medical Center (UPMC) and
GE Healthcare, reported a memorandum of understanding
with Argent Global Services (Oklahoma City, Oklahoma),
a process engineering and management consulting firm, to
help revolutionize the pathology laboratory. The agreement is
intended to provide hospitals and academic research facilities
with operational consulting and change management solutions
that enhance workflow efficiency and enable seamless transition
for adopting digital technologies in pathology labs.
Digital pathology is a new area for many pathologist labs that
traditionally used microscopes to examine tissues. The increased
occurrence of cancer in recent times has raised the urgency
to embrace digital technologies as they have the potential to
enhance clinical and operational results. Digital pathology has
the ability to cut slide processing time by 25%. The use of digital
pathology also enables more collaboration with care teams, which
studies has shown that seeking a second opinion or collaborating
with the care team has the potential to improve the diagnosis and
treatment plan in nearly one in 10 patients.
GE Healthcare provides transformational medical
technologies and services to meet the demand for increased
access, enhanced quality and more affordable healthcare.
Omnyx is a joint venture of GE Healthcare and UPMC (University
of Pittsburgh Medical Center) with locations in Pittsburgh and
Piscataway, New Jersey. The company has developed the Omnyx
IDP solution allowing pathology departments worldwide to
move to an all-digital workflow. Their products include image
acquisition devices, workflow software, and transformation
consulting.
Argent Global Services says it specializes in the
implementation of solutions that increase productivity, enhance
service, improve quality, and reduce costs. //
MEDICAL DEVICE DAILY™ FINANCINGS
Glooko raises $16.5M Series B round
for FDA-cleared diabetes platform
Staff Report
Glooko (Palo Alto, California) reported that it has raised
$16.5 million in Series B financing, which will be used to expand
its FDA-cleared diabetes platform. The platform will include
device data from insulin pumps, continuous glucose monitoring
systems, and integration of personalized predictive algorithms.
Canaan Partners and Medtronic joined existing investors,
including The Social + Capital Partnership and Samsung in the
financing. As part of this round, Canaan Partners’ Wende Hutton
has joined the Glooko board of directors.
“The healthcare industry is at an inflection point with the
advent of the Affordable Healthcare Act and increased demand
for better quality care without raising costs. Companies that
are able to offer unprecedented access to actionable patient
information combined with intuitive mobile applications are
poised to meet those demands,” said Hutton, general partner at
Canaan Partners. “Glooko is the perfect example of a company
that goes beyond developing a simple wearable or mobile
phone app--they have delivered a solution that improves patient
outcomes by engaging both patients and their healthcare
providers to more easily manage and gain insights from the
often complex web of diabetes devices.”
Glooko said its diabetes platform enables patients to
better manage their diabetes and their healthcare providers to
proactively engage their diabetes populations via a mobile, cloudbased platform. Using Glooko’s bluetooth-enabled MeterSync
device, patients are already able to sync data from more than
30 blood glucose monitors (over 90% market share) with their
Apple or Android mobile device. This data is then structured for
providers in a simple to interpret, risk-stratified view via Glooko’s
Population Tracker, a population management tool, and via
integration into other platforms, such as an electronic health
record. Glooko allows healthcare providers to engage at-risk
patients before costly intervention and hospitalizations occur.
In addition, Glooko allows healthcare providers and patients
to create reminders for improved treatment plan adherence,
integrate data from popular fitness trackers and biometric tools,
and allow patients to record food intake and insulin dosage to
provide context around changes in their blood glucose readings.
By adding data from insulin pumps, continuous glucose
monitoring systems and integrating personalized predictive
algorithms into its platform, Glooko said it will bring more
utility to patients who require intensive, day-to-day glucose
management, and make it easier for healthcare providers to get
a full picture of a patient’s health so they can proactively treat
them.
“Glooko has taken the power of mobile, cloud and analytics
innovation to deliver an application that has real, daily use in
PAGE 6 OF 10
helping improve the health of patients with diabetes,” said
Rick Altinger, CEO of Glooko. “We have successfully attracted
partnerships and investments from leaders in diabetes
healthcare to join our mission in creating easy-to-use and
intelligent software that adds utility for patients, healthcare
providers, pharmaceutical companies and payers. The new
investment will further bolster our leadership position in this
area.” //
PRODUCT BRIEFS
• Bruin Biometrics (BBI; Los Angeles), a medical technology
company making biometric sensors for earlier detection of
pressure ulcers (bed sores), said that Wrightington, Wigan
and Leigh (WWL) NHS Trust (London) achieved zero hospitalacquired pressure ulcers in three wards over the last three
months since the pilot adoption of the SEM Scanner, an
innovative technology that detects the early signs of tissue
damage. The adoption of this unique mobile tissue-scanning
device comes in response to NHS leadership’s call for more
efforts to prevent pressure ulcers and a Trust-wide shift from
treatment to prevention to reduce the number of avoidable
pressure ulcers in its hospitals. Despite being largely avoidable
with early detection, widespread prevalence of pressure ulcers
persists. And as a contributing cause of community and hospital
acquired infections, such as sepsis and MRSA, pressure ulcers
have risen to the national health agenda for many countries. The
SEM scanner’s sensor is placed on a patient’s skin where damage
most frequently occurs, for example the heels and sacrum, and
takes readings in about one second. The sensor in the device
measures changes in moisture under the skin and detects the
earliest stages of pressure ulcers.
• VuCOMP (Plano, Texas), a maker of advanced computer
vision systems for the detection of breast cancer, has received
FDA approval for M-Vu CAD for mammography version 3.2. This
latest version of the M-Vu CAD algorithm provides an increase
in sensitivity, resulting in an improvement in mass detection
performance, according to the company. The M-Vu CAD system
was the first mammography CAD product to meet the rigorous
FDA standard that recommends comprehensive reader studies
to prove the effectiveness of CAD systems. VuCOMP continues
to provide systematic product updates, fulfilling the company’s
commitment to ongoing enhancements for its customers.
• Zimmer Holdings (Warsaw, Indiana) reported the
introduction of its first reverse shoulder replacement in the U.S.
using Vivacit-E Liner for the Trabecular Metal Reverse Shoulder
System. Zimmer’s Vivacit-E Vitamin E Highly Crosslinked
Polyethylene (HXPE) is a high-tech bearing surface offering
oxidative stability and low wear that has already become a
staple of the company’s replacement products for the knee, hip
and elbow. Its introduction into the Trabecular Metal Reverse
Shoulder System is designed to meet the growing demand for
shoulder replacement. Zimmer makes orthopedic reconstructive,
spinal and trauma devices, dental implants, and related surgical
products.
MEDICAL DEVICE DAILY™ Edwards
Continued from page 1
device by Edwards Lifesciences (Irvine, California). Bram
Zuckerman, chief of the cardiovascular devices division at FDA,
was in attendance at ACC 2015, and Popma asked for thousands
to hear, “what more information do we really need once the
device performs this well at 30 days?”
Zuckerman has been more conservative about device
reviews than many cardiologists would perhaps prefer, and he
threw a glass of cold water on the data from the first release
of information from the Partners trials at the 2010 edition of
Transcatheter Cardiovascular Therapeutics. Zuckerman said at
the time that FDA was keen on seeing more, not fewer, randomized
trials for interventional cardiology devices (Medical Device Daily,
Sept. 24, 2010), describing the late thrombosis issue associated
with drug-eluting stents as the “DES trauma.” Four years would
pass between the CE marking of the first-generation Sapien and
an FDA imprimatur, a lag that has rankled cardiologists as well
as device makers.
Susheel Kodali of New York-Presbyterian Hospital (New
York) presented on the Sapien 3, first mentioning that the
device’s outer skirt was “designed to create a better seal” with
the aortic root. He said the design of the delivery sheath offers
improved coaxial alignment with the native valve, and that the
valve can be delivered with a 14 French sheath.
The trial of nearly 1,700 patients (538 of whom were
deemed either high-risk or inoperable, with the balance made
up of intermediate-risk patients), examined the device in a
predominantly transfemoral access point (transapical and
transaortic procedures accounted for 211 cases). The inoperable/
high-risk arm yielded a 30-day, all-cause mortality rate of 2.2%,
with patients in the transfemoral group coming in at 1.6%.
Cardiac mortality for all enrollees was 1.4%, and again, those
implanted transfemorally were better off, at 1.0%.
Paravalvular leak data were among those that impressed,
with 3.7% of patients in the so-called Partner II S3 study exhibiting
moderate leak, while only 0.1% suffered severe leak. According
to a press release published by ACC, “currently approved devices
have rates of moderate or severe paravalvular leak in the range
of 10%-20%.” The Sapien 3 is also said to greatly increase the
ratio of patients who can be implanted transfemorally, from
60% on the first-generation device to 90%. The rate of disabling
stroke in Partner II S3 was 1% for all enrollees, a number that
varied little by group.
Kodali remarked that the evolution of this device has yielded
numbers that indicate “at least parity with the best surgical
outcomes, and possible superiority,” and he said the improved
leak numbers are in part because, “we’re doing the procedure
better.” He said the modified skirt on the Sapien 3 gives the
interventionalist more breathing room, but he added, “even with
negative sizing, we still got lower rates” of adverse events.
PAGE 7 OF 10
Embolic events tend to revolve around device positioning
issues, Kodali added, but he pointed out that the Sapien 3 is a
lower profile device than its antecedents, and thus, “you’re not
manipulating the valve as much during positioning.”
Popma prefaced his remarks by advising all in attendance
he might say something provocative, but he was one of several
who cheered the numbers. “The bar keeps getting higher and
higher” for TAVR, Popma enthused, at which point he posed the
question of whether such data (presumably coupled with OUS
experience) should suffice for regulatory approval. Edwards
obtained a CE mark for the Sapien 3 in January 2014.
Not all the discussants were on board with Popma, and
one of them asked Kodali whether he thought more data are in
order before device approval. “Absolutely,” Kodali responded,
explaining, “in terms of late events, were not going to see signals”
until five years out. “Now, maybe TAVR should be the preferred
therapy,” for the higher-risk patients rather than surgical
AVR, Kodali stated, but of the intermediate risk population,
“conversations are going to be different moving forward.”
Popma nonetheless held his ground, asserting that the
Sapien 3 “is a progressive iteration of what’s already been done”
with prior models. “Do we still need a 1,000-patient trial for each
device iteration that comes along?” he asked. Kodali seemed to
acknowledge that Popma had a point on the high-volume trial
question for each TAVR device iteration, musing, “we don’t do
that with surgical valves.”
Sapien scores well on durability
Regulators are enamored of longer-term data than are often
available when a sponsor completes a PMA, and Michael Mack
of Baylor Heart Center (Plano, Texas) dove into the five-year
numbers behind the Partner 1A cohort, comparing the Sapien
to surgical valve replacement in high-risk patients. Most of the
data were similar across the two groups, but device durability
provoked most of the commentary.
Mack said he saw no evidence of structural valve
deterioration in either arm, but the original Sapien is still
dogged by paravalvular leakage, which accounted for most of
the regurgitation in the device arm. On the other hand, surgery
was associated with more bleeding events, and the rates of
re-hospitalization varied within the TAVR arm, occurring more
frequently by eight percentage points for those undergoing
transapical implant than those placed transfemorally.
Popma asked Mack, “is it time now to say that the durability
. . . is the same as a surgical valve, or do you still need more
information?” Mack replied, “I don’t think we can put that to
bed yet.” He pointed out that durability is calculated only by
those who are still alive, adding, “although there is no signal of
structural valve deterioration … at five years, there are a lot of
surgical valves that are still good, too.”
Mack emphasized that the data offer “some degree of
reassurance,” but declined to characterize this as a closed
debate. Edwards is said to have agreed to follow these patients
for another five years. //
MEDICAL DEVICE DAILY™ Medtronic
Reardon said the two-year data in this population “will set
a new standard” for TAVR, and made note of moderate to severe
valve leakage for high-risk patients on the CoreValve, which
was steady at year two compared to year one (6.1% compared
to 6.0%, respectively). The analysis of 390 patients on the
device and 357 controls (surgical AVR, or SAVR) disclosed that
all-cause mortality favored the device over SAVR (roughly 22%
for the device vs. more than 28% for the comparator), a wider
interval than seen in one-year data. Death rates at one year were
14.2% for the device and 19% for surgical replacement. “The
superior survival we saw at one year was sustainable, durable
and actually widening,” Reardon said.
Nearly 11% of patients in the device arm experienced stroke
of some severity while 16.6% of those on surgical AVR likewise
had stroke indications, but the percutaneous device also held
the edge on major stroke (6.8% compared to 9.8% on SAVR).
However, the rate of pacemaker implantation for the device was
more than double that seen in the surgical arm (25.8% and
12.8%, respectively) and 2.5% of the CoreValve patients needed
a second intervention, compared to 0.4% of the SAVR patients.
Physicians and FDA will have to consider those numbers as
well as the rates of major bleeding events, which favored the
CoreValve group by a hefty margin (18% vs. 39% for SAVR).
Reardon observed that the Partner trials likewise disclosed
a bump in stroke for the study article, but indicated that
Medtronic put more effort into determining the incidence than
Edwards. “This is the most rigorous trial looking for neurological
complications I know of,” he testified. Reardon added that the
numbers showed significant improvements in New York Heart
Association classification of heart failure. Most of the patients
enrolled in class III or IV, but he said, “by the end of year one,
they’re almost all in class I or II.”
Device durability is a concern, Reardon acknowledged,
echoing comments heard in connection with the Sapien as well,
but he noted that imaging offered no indication of deterioration.
He said also that valve orifice and pressure gradients “were
statistically superior for TAVR at every time point during the
trial.”
Reardon emphatically touted the implications of the data,
stating that TAVR “is the preferred alternative in this (high-risk)
group,” concluding that the device “sets the bar, and it sets the
bar high.”
Medtronic; no 30-day stroke for Evolut R
Edwards Lifesciences (Irvine, California) may have enjoyed
the spotlight for the presentation of 30-day data for the Sapien
3, but Medtronic had to make do with a poster session for getting
the news out about the second-generation CoreValve Evolut
R. The 60-patient study conducted in Australia, New Zealand
PAGE 8 OF 10
and the UK for high- and extreme-risk patients demonstrated
“exceptionally positive outcomes with no incidents of all-cause
mortality or stroke,” the company said in a March 14 statement.
The Evolut R relies on a 14-French delivery system dubbed
the EnVeo, and Medtronic made a point of emphasizing
paravalvular leak numbers and the ease with which the device
can be implanted. The company said that practitioners were able
to implant all but one patient transfemorally, which Medtronic
said was due to the EnVeo.
Another problem seen in only one patient was incorrect
valve position, and Medtronic added that no cases of valve
dysfunction occurred, either. Other outcomes that did not occur
were procedural death, annular rupture, coronary occlusion,
valve embolization, and conversion to surgery. The statement
said the rate of pacemaker implant “was low at 11.7%.”
The company said nearly 97% of patients experienced no
worse than mild paravalvular leak at 30 days, credited to the
“new, extended sealing skirt” on the 26 and 29 millimeter sizes
(the device is also configured at 23 millimeters). Medtronic
reminded that the device is available in more than 60 countries
thanks to a CE mark awarded the device in September 2014.
Outside-U.S. implants total in excess of 75,000, the statement
indicated.
Ian Meredith of Monash Heart - Monash Health (Melbourne,
Australia), said in the statement that the early experience
with the device “ushers in a new era of TAVR technology that
provides increased confidence with recapturability, excellent
procedural results, and impressive clinical outcomes. Meredith,
a co-principal investigator of the study, said the EnVeo system
“allowed transfemoral access for most patients, and the
recapturable technology enabled implanters to optimize valve
placement for improved annular sealing and reduced conduction
disturbances without compromise on mortality or stroke.” //
HIT BITS
HeartIT launches CloudCMR
for cardiovascular MRIs
Staff Report
HeartIT (Durham, North Carolina) said it has launched a
brand new solution, CloudCMR, designed to promote worldwide
sharing of de-identified cardiovascular magnetic resonance
images for education, research, and quality control purposes.
CloudCMR takes research and collaboration to the next level
by offering a centralized location where colleagues can collect
cases from multiple geographically or politically separated centers.
Brent Reed, Chief Technology Officer said in a release, “Heart
Imaging Technologies has always been focused on promoting
CMR research and now offers an advanced, secure sharing
platform which both clinicians and researchers can leverage. By
integrating the cloud into physicians’ clinical workflow solutions,
CloudCMR provides unprecedented levels of accessibility and
sharing potential for CMR professionals.” //
MEDICAL DEVICE DAILY™ Keystone
lesions thanks to the Keystone device whereas none of the
patients on the Medtronic (Dublin) CoreValve were entirely free
of such lesions.
It should be pointed out also that only 32% of those
randomized to embolic protection received the CoreValve,
whereas those implanted with the Edwards Lifesciences
Sapien series (including the original, the XT and the Sapien 3)
accounted for close to two thirds of those receiving protection.
The remaining 2.3% of those on the study device received other
TAVR offerings, but the gap between CoreValve and Sapien
among controls (those who received no TriGuard) grew to 40
percentage points (26% and 66%, respectively).
While at first glance this data could look like just another
clash between the two of med-tech’s largest firms - Medtronic
and Edwards - in the TAVR space, the key player in the story is
undoubtedly Keystone Heart, a company founded in 2004 and
funded by OrbiMed Advisors and OrbiMed Israel Partners.
TriGuard, the firm’s flagship product, is designed to cover all
three aortic cerebral branches to minimize the risk of cerebral
damage during TAVR and other cardiovascular procedures. It
designed for placement via one of two femoral artery access
ports. The TriGuard accommodates most anatomical variations
of the aortic arch and uses a Nitinol frame and mesh — flexible
and atraumatic, yet robust and sturdy, according to the company
“DEFLECT III was an exploratory study,” Shuki Porath
president/CEO of Keystone Heart, told Medical Device Daily.
“It is the first time ever that anyone has done a multi-center
randomized trial on this. We were very much pleased with what
we have seen in the results.”
Since it is an exploratory study, data on 30-day follow-up
won’t be available until April 4.
The preliminary findings of the DEFLECT III trial were
presented by Alexandra Lansky, associate professor of medicine
(cardiology) at Yale School of Medicine.
“One of the major findings is, for the first time, we’re showing
that with protection, 55% more patients have completely clean
brains - with no ischemic brain lesions at all,” said Lansky in a
release. “Brain lesions increase risk of dementia and stroke twoto three-fold.
Researchers noted that the neurocognitive function data
also stands out.
The researchers used the Montreal Cognitive Assessment
(MoCA) to evaluate the impact of TriGuard on cognitive factors
such as language, memory, attention, recall, and orientation.
“Whether we’re looking at MoCA or looking at short-term
memory or delayed memory, we’re seeing an improvement
in cognitive function as early as hospital discharge among
protected patients, compared to controls,” she said in a release.
Results show that use of the TriGuard was safe with
PAGE 9 OF 10
numerically better in-hospital procedure safety; patients
protected with TriGuard during TAVR were more likely to be
free of new brain lesions post-procedure, particularly when
TriGuard was used during implantation of Edwards’ Sapien
family of valves; complete freedom from ischemic brain lesion
was observed in 50% of TriGuard protected patients treated
with Sapien 3 – an unprecedented level not previously reported
in any study; on DW-MRI post-procedure, single and maximum
brain lesion volume was reduced by about 40% as compared to
control patients who did not have TriGuard protection.
Next steps call for further studies and seeking approval. The
company has had CE mark for the device for nearly two years
now, but plans are underway for it to begin its journey down the
regulatory pathway in the U.S.
“[DEFLECT TRIAL III] will lead us into an IDE trial for the
U.S.,” “We’re already in the process of working on the trial.”
The medical community is witnessing heightened focus
and scrutiny on cerebral injury concurrent with cardiovascular
procedures – and research on possible preventative measures
and devices to protect against brain injury has increased. Data
from the PARTNER A study show nearly twice as many strokes
in the TAVR group compared with the surgical Aortic Valve
Replacement group at 30 days, the majority of strokes being
peri-procedural and within the first two days. In addition, newer
“next generation” TAVR devices have so far have apparently
failed to reduce TAVR-related risk of stroke.
Keystone Heart is hoping that the data shows that
TriGuard may provide such protection during TAVR and other
cardiovascular procedures. //
M&A
EPS accretion to BD in the first full year, and is also expected to
be accretive to GAAP EPS in fiscal year 2018.
In other M&A activity;
• Elekta (Stockholm, Sweden) reported its acquisition of
RTA (Warszawa, Poland), as announced Aug. 25, 2014. This deal
will allow Elekta to leverage RTA’s existing relationships in order
to strengthen Elekta’s position in Poland’s private and public
health care sectors.
With this finalization, RTA will change its name to Elekta
and become a subsidiary.
• HealthStream (Nashville, Tennessee), a provider of
workforce development and research/patient experience
solutions for the healthcare industry, has completed the
acquisition of HealthLine Systems (San Diego).
Through this transaction, market-leading products for
credentialing, privileging, quality management, and contact
center optimization are added to HealthStream’s comprehensive
solution offering for healthcare organizations.
The purchase price for the acquisition was approximately
$88 million, which was paid in cash. //
MEDICAL DEVICE DAILY™ U-Light
(Vancouver, Canada).
Point-of-care applications represent the fastest-growing
segment of the overall market for ultrasound equipment,
according to iData’s 2015 report, “U.S. Market for Ultrasound
Imaging Equipment.”
Introduced in November 2014 at Medica in Dusseldorf, the
U-Lite made its U.S. debut at the meeting of the Radiological
Society of North America (RSNA) in December, 2014. As a
testimony to the novelty of the device, visits by professionals from
competing companies at the European Congress of Radiology in
Vienna in March, 2015 crowded out curious radiologists.
The POC segment for ultrasound includes dozens of higher
performing 10-pound laptop computer versions that technically
are portable, but there are only a handful of truly hand-held
models that vie to replace the stethoscope. Here the market
leaders include SonoSite (Bothell, Washington), GE Healthcare
(Chalfont, UK) and Siemens (Erlangen, Germany).
And here, the trade-off for pocketable portability is image
quality, notably with a 3.5-inch screen size that looks like a
throwback to dumb phones.
What is drawing ultrasound companies and doctors to the
U-Lite is its high definition 7-inch tactile screen that looks and
acts like a tablet computer with fingertip control of functions
and menus. The view also rotates from portrait to landscape.
In contrast, the handheld Vscan from GE or the Acuson P10
from Siemens have dials and buttons for navigation and a fixed
display.
“The heart deserves better than a postage-stamp view,”
said Bruno Richard, the Scientific Director from Sonoscanner
who spoke with Medical Device Daily from his office in the center
of Paris.
“We are the first to present this level of technology
integration in a true, hand-held tablet format with all the
features of conventional ultrasound scanners, such as color
Doppler, pulse wave Doppler, tissue harmonic, or compound
imaging,” he said.
While the U-Lite can slip into the side pocket of a doctor’s
lab coat, and is less than one-inch in thickness, packing these
diagnostic capabilities into a hand-held model makes for a hefty
tablet weighing 1.7 pounds, though that includes the ultrasound
probe.
Another advantage for the U-Lite is that it comes with
four interchangeable probes: linear, convex, phased array and
endovaginal. Siemens has a single probe and GE offers a dualpurpose probe for their hand-held models.
A useful battery life or three hours of continuous scanning
also largely exceeds competitive models.
Selling at $10,500, the U-Lite price comes in above the
Siemens Acuson P10 and GE Vscan priced at $7,500 but below
PAGE 10 OF 10
the Philips VISIQ tablet scanner priced at $15,000.
The U-Lite holds a CE mark for commercialization in Europe
and approval is currently pending with the FDA.
Created in 2003, Sonoscanner is privately held and selffunded, running off a revenue stream generated by sales of two
existing ultrasound platforms, the Orcheo Lite and Orcheo XQ.
The U-Lite is manufactured by the company in Paris, and
Richard said there is sufficient capacity at the facility to meet
orders expected for the near term.
Except in France where the company sells direct,
commercialization is through distributors in all geographies.
In the U.S. the company is currently setting up a distribution
network in anticipation of FDA approval. //
PEOPLE IN PLACES
• Apollo Endosurgery (Austin, Texas) has named Stefanie
Cavanaugh as chief financial officer. Prior to joining Apollo,
Cavanaugh was senior VP of finance for Harden Healthcare from
2010 until its sale to Gentiva Health Services in 2014. Apollo
Endosurgery specializes in minimally invasive endoscopic
surgical products for bariatric and gastrointestinal procedures.
• Stephanie Tortorici joined Jarrard Phillips Cate & Hancock
(Brentwood, Tennessee) as managing director for the Chicago
office. Tortorici, a former executive vice president with Edelman,
was most recently director of health in Chicago for Edelman’s
Zeno Group after serving as EVP in the health practice at Edelman
PR. Jarrard is the a communications and public affairs firm for
any hospital or health system in the nation experiencing a time
of significant change, crisis or opportunity. The firm publishes
healthcare newsletter Inside Baseball and ranks among the top
15 healthcare PR firms in the U.S.
• MRI Interventions (Irvine, Califorina) said that seasoned
medical device financial executive Harold Hurwitz has been
named the company’s next chief financial officer. Hurwitz will
join the company on March 30 initially as VP, finance, and
he will then assume the CFO position following the filing of
the company’s quarterly report on Form 10-Q for 1Q15. Most
recently, Hurwitz served concurrent roles as CEO, CFO, treasurer
and secretary of Pro-Dex. MRI Interventions makes platforms for
performing the next generation of minimally invasive surgical
procedures in the brain and heart. The company’s ClearPoint
system uses a hospital’s existing diagnostic or intraoperative
MRI scanner to enable a range of minimally invasive procedures
in the brain.
• Sequenom (San Diego), a life sciences company
committed to enabling healthier lives through the development
of innovative products and services, said its board elected
Kenneth Buechler as chairman, effective April 1. Buechler
succeeds Harry Hixson, Jr, who will retire from the position
effective March 31, after 11 years of service. Buechler, has served
on the board of directors since December 2009. Sequenom
serves patients and physicians by providing early patient
management information.
ONCOLOGY EXTRA
Keeping you up to date on recent developments in oncology
Radiotherapy for pediatric patients linked
to lifetime risk of panhypopituitarism
Radiotherapy and radiosurgery are lower-risk undertakings
than in times gone by, but a recent statement at cancernetwork.
com indicates that these procedures performed on the skulls
of children can damage pituitary function. A study appearing
in the Journal of Clinical Oncology spelled out some of the
findings gleaned by a team led by Wassim Chemaitilly of St.
Jude Children’s Research Hospital (Memphis, Tennessee)
after a retrospective review of the records for more than 700
participants in the St. Jude Lifetime Cohort (SJLIFE) study, said to
have been designed to evaluate late-onset endocrine effects of
radiotherapy. All the subjects involved had been diagnosed and
treated for childhood leukemia (accounting for more than 72%),
lymphoma, and brain and other cancers, and had undergone
brain radiotherapy.
The numbers indicate that more than 51% of these patients
had a deficiency in at least one hormone, while another 11% had
more than one hormonal deficiency. Nearly 53% of the subjects
were male, and the mean age of the cohort was 34 years, with
an average of 27 years elapsed since the diagnosis of childhood
cancer. Growth hormone deficiency affected 46% of the patients,
while nearly 11% experienced a lowering of gonadotropin
secretion. As might be expected given the distribution of cells
across the volume of the pituitary, only 7.5% had a thyroidstimulating hormone deficiency, and one in 25 had had a
problem with output of adrenocorticotropin.
Chemaitilly was quoted as saying that the data “underscore
the need for the nation’s growing population of childhood
cancer survivors to get recommended health screenings, and
the challenges they face in trying to navigate the healthcare
system and follow that advice.” The title of the article is “Anterior
Hypopituitarism in Adult Survivors of Childhood Cancers Treated
With Cranial Radiotherapy: A Report From the St Jude Lifetime
Cohort Study.”
Radiosurgery For brain cancer
There were approximately 1,252,000 new cases of
invasive cancer diagnosed in the U.S. in 1995. Symptomatic
brain metastases would have developed in 13.5% (169,020)
of these patients. Half of these patients would have solitary
brain metastases by computed tomography (CT) scan, and
somewhat fewer (an estimated 60,000) would have solitary
brain metastases by magnetic resonance imaging (MRI) scan.
Resection versus Radiosurgery (U.S.): Based on the experience
at the University of Minnesota between 1973 and 1993, about 40%
(34,649 by CT and 24,600 by MRI) of these patients will have
controlled systemic disease and adequate performance status to
WEDNESDAY, MARCH 18, 2015
justify surgical resection. It is estimated that one-third of these
patients will require relief from mass effect, an absolute indication
for surgery. The other two-thirds (or 23,215 by CT and 16,482 by
MRI) of these patients represent the group that is currently treated
with surgical resection and whole brain radiation therapy who
could be treated with radiation plus stereotactic radiosurgery.
The marginal cost of radiation plus surgical resection compared
to radiation plus radiosurgery ranges from $10,609 (average
Medicare reimbursement) to $15,236 (average private insurance
reimbursement). To calculate the potential annual savings
to society based on the Medicare data, one multiplies 16,482
patients per year times $10,609 savings per patient for a total
savings of an astounding $175 million per year in the U.S. alone.
This represents the most conservative estimate and is based on
Medicare data, not private insurance reimbursement.
Recommendations: Standard therapy for patients with
a solitary brain metastasis should be as follows: patients with
uncontrolled systemic disease or poor performance status
(Karnofsky score less than 60) should receive whole brain
radiation therapy and steroids; patients with controlled systemic
disease and adequate performance status should receive
radiation plus stereotactic radiosurgery; and patients who
require relief from mass effect, have stable systemic disease,
and adequate performance status should undergo surgical
resection and whole brain radiation therapy (see Article Review:
“Radiosurgery, Cost-Effectiveness, Gold Standards, the
Scientific Method, Cavalier Cowboys, and the Cost of Hope”
as cited in the Incidence and Prevalence Database).
Study confirms MLL mutations to
blame for most pediatric leukemias
Sometimes it requires some legwork just to ensure you’ve
found your genetic target, and a recent statement by St. Jude
Children’s Research Hospital (Memphis, Tennessee) makes that
argument for the MLL gene and a rare subtype of pediatric acute
lymphoblastic leukemia (ALL). The March 6 statement points
to a study in Nature Genetics under the title “The landscape of
somatic mutations in infant MLL-rearranged acute lymphoblastic
leukemias,” which disclosed that the leukemia cells of as many
as four in every five infants with ALL have fusion of the MLL
gene to another gene located on a different chromosome,
creating an aberrant protein. The statement indicates that the
study entailed the use of whole genome sequencing “and other
techniques” to pinpoint the genetic alterations in 65 infants
with ALL, 47 of which bore the errant MLL fusion. Nearly half
the infants with MLL-rearranged ALL demonstrated activating
mutations in the tyrosine kinase-phosphoinositide-3-kinase
(PI3K)-RAS pathway, although the mutations were not present
Continues on next page
MEDICAL DEVICE DAILY™ EXTRA
PAGE 1 OF 2
ONCOLOGY EXTRA
Continued from previous page
in all leukemic cells. Researchers at St. Jude are investigating
compounds and combination therapies to improve cure rates for
infants with the MLL rearrangement, a big imperative given that
85% of pediatric ALL patients experience long-term, cancer free
survival compared to 36% or less of infants with the high-risk
subtype.
Going to the dogs for thyroid cancer
The canine nose is a marvel of nature, and a recent
statement by the Endocrine Society (Bethesda, Maryland)
offers yet more evidence that it’s a dog’s world sometimes
where cancer diagnosis is concerned. The statement points to
a paper to be presented at the association’s annual meeting
in San Diego offering details of a study of 34 patients who
presented a urine sample on their first visit to a clinic before
biopsy. Pathology indicated that 15 patients had thyroid cancer
while the remaining 19 had “benign” disease. and benign
thyroid disease in 19. These urine samples were presented, by
a gloved dog handler, one at a time to Frankie to sniff. Neither
the dog handler nor the study coordinator, who recorded the
dog’s responses after the handler announced them, knew the
cancer status of the 34 urine samples. The dog sniffed out the
correct interpretation in 30 of the 34 samples, for a sensitivity
of 86.7%. Canine specificity was just shy of 90%, (two falsenegative results and two false-positives) using canine scent
detection. Donald Bodenner of the University of Arkansas for
Medical Sciences (UAMS, Little Rock, Arkansas) said, current
tests “often yield uncertain results, leading to recurrent medical
procedures and a large number of thyroid surgeries performed
unnecessarily.” Bodenner added that the dogs “could be used
by physicians to detect the presence of thyroid cancer at an early
stage and to avoid surgery when unwarranted.”
The value of a penny’s worth of copper
They say two cents won’t buy much today, but don’t believe it.
A recent statement by Bielefeld University (Bielefeld, Germany)
describes research into the use of a copper-containing molecule
“that binds specifically with DNA and prevents the spread of
cancer.” Early returns on this effort suggest this method might
beat cisplatin. The researchers integrated two metal ions of
copper into a molecule that binds with phosphates, at which
point, the DNA of the cancer cell is damaged, which disrupts
cellular processes sufficiently to prevent reproduction. The
molecule is described as bearing the two copper ions in a fashion
suggestive of a horseshoe, the gap between which is said to
match the gap between the phosphates in the DNA. The article
explaining all this appears in Inorganic Chemistry under the title,
“Rational Design of a Cytotoxic Dinuclear Cu2 Complex That
Binds by Molecular Recognition at Two Neighboring Phosphates
of the DNA Backbone.”
WEDNESDAY, MARCH 18, 2015
Graphene nanoparticles may prove
effective across cancer types
Honeycombs built by bees store a substance prized by
ursines and hominids alike, but the typical bear might not
appreciate the benefits of the carbon honeycomb we know as
graphene as much as an oncologist. Scientists at the University
of Manchester (Manchester, UK) prepared a variety of graphene
oxide formulations for testing against six different cancer types,
including breast and pancreatic cancer, turning out graphene
flakes said to have inhibited tumor sphere formation in all six
types. The graphene is credited with readily attaching to or
bypassing the cancer stem cell membrane, but the graphene
oxide used in this study seems to be an effective anti-cancer
treatment as a solo act by prompting those cells to differentiate
into non-cancer stem cells. The authors acknowledge that
this is very early-stage work and will need more development,
but the graphene oxide also appears to be minimally toxic to
adjacent cells. The article appeared recently in Oncotarget under
the title, “Graphene oxide selectively targets cancer stem cells,
across multiple tumor types: Implications for non-toxic cancer
treatment, via “differentiation-based nano-therapy.”
Berkeley Lab hits tabletop accelerator milestone
Particle accelerators are not yet the stuff of the hobbyist, but
Berkeley Laboratories, a unit of the U.S. Department of Energy,
has come up with a tabletop particle accelerator capable of
imparting acceleration energies in excess of four giga-electron
volts. A December 9 story at Gizmag.com states that scientists
at Berkeley pulled it off in a tube a mere 3.5 inches in length,
although the feat was assisted greatly by Berkeley’s laser
accelerator, the Bella laser, which can juice subatomic particles
with a petawatt of energy. Just to be on the safe side, the
scientists at Berkeley made use of the National Energy Research
Scientific Computing Center (NERSC) to ensure they would not
blow up themselves and their lab. The authors explain how they
did it in Physical Review Letters in an article titled, “Multi-GeV
Electron Beams from Capillary-Discharge-Guided Subpetawatt
Laser Pulses in the Self-Trapping Regime.”
MDD is on Twitter!
Stay Connected. Follow Us on Twitter!
www.twitter.com/meddevicesdaily
MEDICAL DEVICE DAILY™ EXTRA
PAGE 2 OF 2
Fuel
powerful
SUPER
advances.
Biotech is more than just a job. It’s a mission to feed, fuel and heal the world. And there’s no
better place to connect with biopharma’s top people and most innovative technologies than
at BIO 2015. The ideas and information shared at BIO go beyond professional development.
You’ll experience powerful business partnering, benefit from invaluable education sessions
and have the chance to network with 15,000 of the industry’s best and brightest. See how
the everyday becomes extraordinary — at BIO 2015.
Learn more at convention.bio.org #BIO2015
SUPERcharge your BIO experience.
convention.bio.org

medical device dailytm the daily medical technology news source

Transcription

Similar documents

BIOWORLD TODAY

Nursing and Residential Staffing Solutions

Inlandsbanan A3.indd

Publicatie Vijver Corten staal Eng2 2014

close to home short distances quick help child care employee

Enecsys Micro Inverters - Zelf Energie Produceren

Crankshafts - Texma Petroleum Machinery

View property schedule

Unbreakable

Property details 180816_11353434_1

the brochure.