Jan 2003 - IMDA.org

JANUARY 2003
GPO strives to open its doors
N
OVATION wants manufacturers to
know that it’s taking new —
make that “better” — technology
seriously.
The Irving, TX-based purchasing
group has taken a number of steps to
make sure that it creates opportunities
for manufacturers of new technologies,
including posting a “Technology Forum”
on its website and appointing a senior
director of safety, technology assessment and QA/RA.
Though she’s proud of Novation’s
record in assessing new technologies,
Cathy Denning, R.N., M.S.N., the newly
appointed senior director, says the program is steadily improving.
Much of that improvement is based
on Novation’s new “operating principles,” formulated in August 2002, in
which the GPO pledged to “ensure that
member hospitals have timely access to
new and innovative technologies.”
Among the GPO’s pledges were the following:
ate Subcommittee hearings about the
group purchasing industry, and a rash
of New York Times articles critical of
GPOs.
A registered nurse, Denning began
working for Novation three years ago as
IV systems product manager. For thirteen years prior to that, she worked in
the home infusion and high-tech home
care industries, including a program for
pediatric ventilator patients. She is an
oncology nurse by training.
In addition to making sure that Novation gives innovative technologies a
shot, Denning also is charged with ensuring that Novation considers the
safety aspects (to health care workers
and patients) of products under consideration, and the quality of those products and the companies who make them.
ANNUAL MANAGEMENT
CONFERENCE
Four days into the future
C
AN YOU SPARE four days in May
Novation has incorporated language
about innovative technology into its
standard invitation-to-bid, says Den-
to take a good look at your
future?
IMDA Conference Chairman Stan
Tangalakis has already lined up four
high-powered speakers for the Annual
Management Conference to help you do
just that. And planning continues!
“The future for specialty sales and
marketing organizations looks brighter
and more promising than ever,” says
Tangalakis, who is CEO of Mercury
Medical, Clearwater, FL. “But we have
to expand the scope of our corporations
in order to embrace that future. We have
to anticipate the technologies that we
will be selling and the health care system in which we will be operating. We
have selected our speakers carefully to
serve as practical guides to that future.”
The conference will be held from May
28 through May 31, at the luxurious Stein
Eriksen Lodge outside Salt Lake City. As
see “GPO,” page 3
see “Conference,” page 2
Opening up the bid process
䡲 Novation’s review of innovative technology will include increased involvement of hospital members and, where
appropriate, outside experts.
The Stein Eriksen Lodge
䡲 Novation will increase communication about innovative technology to
all relevant audiences.
䡲 Novation will re-bid product agreements or add vendors to agreements
in the event that a new technology
enters the market offering incremental patient care or incremental safety
benefits, based on review and recommendation by member councils.
䡲 Future contracts for clinical preference products that demonstrate incremental patient care and/or
incremental safety benefits will be
dual/multi-source awards, subject to
member review and approval.
The operating principles were published in the wake of last spring’s Sen-
IMDA Update
1
January 2003
in years past, the conference will include
a Manufacturers Forum, in which manufacturers seeking representation will
exhibit their devices. It will also mark
the first meeting in which manufacturers can attend as allied members.
Time has been allotted on Friday and
Saturday afternoons for attendees and
their families to play golf or enjoy the
spectacular surroundings. The Stein
Eriksen Lodge is the winner of the
Conde Naste #1 and #2 Best Mainland
Resort, the AAA Four Diamond Award
and Mobile Four-Star Award. It is located amidst aspens and pines, surrounded by the Wasatch Mountains,
8,200 feet above sea level. Given the
affordable rate being extended to IMDA
members, many will no doubt stay the
weekend and beyond.
The scenery will be grand. So will the
speakers, promises Tangalakis. They
will address topics specially selected to
help guide IMDA members to success
in the 21st century.
Dr. Peter Salgo. A medical correspondent for CBS and CNBC, as well as a
practicing physician and recognized futurist, Salgo will help IMDA members
figure out who’s going to be calling the
shots in healthcare in
the years ahead.
In just the last two
years, Salgo has published articles on
drug pricing schedules in the United
States as compared to
other Western nations; chronic fatigue
syndrome; the current progress of fetal
surgery; and the effect of AIDS on its
victims. He has appeared on CBS Television Network, the CBS Radio Network
and the CNBC Television Network. Most
recently, he wrote, produced and anchored four broadcasts per week for
CNBC’s America’s Vital Signs.
For the past 10 years, as a correspondent with WCBS-TV News, Salgo has
written, produced, edited, directed and
commented on medical news and education issues, including AIDS and the
homeless, infertility, radiation treatment,
heart assist techniques and the future
of modern medicine. Salgo practices
anesthesiology and internal medicine at
Presbyterian Hospital in New York City,
and teaches anesthesiology and internal medicine at Columbia University.
Dr. Jeffrey Bauer. A health futurist
and medical economist, Bauer has become one of the country’s foremost experts on how automation is changing
IMDA Update
The Stein Eriksen Lodge ... is located amidst
aspens and pines ... 8,200 feet above sea level.
health care. He will show IMDA members how it will affect
their businesses and
those of their future
customers.
Bauer is senior
vice president of Superior Consultant
Company, Southfield,
MI, a provider of digital business transformation services to the healthcare industry. He has written 60 articles, nine
books and a number of videos on health
care delivery. His latest book is Telemedicine and the Reinvention of Health
Care: The Seventh Revolution in Medicine (McGraw-Hill, 1999). His two previous books are Not What the Doctor
Ordered: How to End the Medical Monopoly in Pursuit of Managed Care and
Statistical Analysis for Health Care Decision-Makers: Understanding and
Evaluating Critical Information in a
Competitive Market.
Bauer received his Ph.D. in economics from the University of Colorado-Boulder, and was a teacher and administrator at the University of Colorado Health
Sciences Center in Denver. He served
as health policy adviser to Colorado
Governor Richard Lamm from 1980 to
1984.
He is a senior fellow at the Center
for the New West in Denver, where he
participates in studies of advances in
medical science and technology and
their impact on the delivery of health
services.
John “Dr. Revenue” Haskell. Since
1974, Dr. Revenue has delivered a
unique brand of “in
the trenches” consulting services to a
wide variety of clients. He has written
over 400 marketing
and sales plans for
mid-size and smaller
companies. His clients consistently see
exceptional sales and profit growth as
a result of his prescriptions. IMDA members will too.
His message is loud and clear: The
most important action you can take to
help your business grow and prosper is
to develop a written marketing and sales
plan. In his workshop at the Annual Conference, Dr. Revenue will show IMDA
2
members how to do just that.
A columnist for the Los Angeles Business Journal and other industry publications, Haskell has served in senior
marketing positions with Abbey Rents
Furniture Division, Sara Lee Corp.,
Gamble Rents Division, and Haskell of
Pittsburgh.
William Prows. Prows will show
IMDA members the difference between
a successful IDN and a dysfunctional
one. He’s an expert on the topic, given
the fact that he is vice president of
shared and affiliated services at Intermountain Health
Care, Salt Lake City.
Intermountain was
recently ranked the
No. 1 IDN in America
by Modern Healthcare magazine.
Prows is responsible for the management and direction of
Shared Services, a division of IHC Hospitals Inc., which includes laboratory
services, pharmacy services, radiology,
materials management and other support service areas. Additionally, he is
responsible for the marketing, management and strategic development of IHC
Affiliated Services Inc. (a for-profit subsidiary of not-for-profit IHC), which supports IHC’s affiliated members of
AmeriNet, of which IHC is a founding
member.
Prows will show IMDA members
how Intermountain has successfully
managed to keep its prices to its customers 27 percent below the market;
how it has earned the support of its
2,500 physicians for its programs; and
how it decides which new medical technologies to buy.
And there’s more...
In addition to these speakers,
Tangalakis has enlisted executives from
key manufacturers, including Datascope
and Masimo, to dialogue with IMDA
members on how to tune up relations
between manufacturers of innovative
technologies and specialty sales and
marketing organizations.
IMDA members will receive a full
Conference brochure and registration
form around Valentine’s Day. In the
meantime, reserve May 28-31 for the
year’s premier event for specialty sales
and marketing companies. 䡺
January 2003
GPO
...continued from page 1
ning. If a manufacturer wants Novation
to consider its technology new and innovative, it must submit FDA and patent
information. Novation will sign non-disclosure agreements, if the manufacturer
wishes.
“When we receive information about
a particular product, we will research
the literature and access third-party assessment groups if necessary,” she says.
Ultimately, the information will be
brought to one of Novation’s approximately 35 member councils and task
forces, who decide whether or not the
technology is indeed innovative and
better than the existing standard, and
if so, whether it should be brought on
contract. “It could be innovative but not
better, and it could be new but not innovative,” she says. “So we have to triage and sort through that.”
Novation can call upon its member
market research department for more
information, says Denning. The department surveys the general membership
or segments of it to obtain further information about particular products being
considered for contract, or about particular features of products.
Technology Forum on the Web
Visitors to the Novation Website
(www.novationco.com) will find a new
section called Technology Forum. Open
to the public and all suppliers (both off
and on contract), the section allows
suppliers to publicize their new technologies.
The Technology Forum links to each
supplier’s site, for visitors interested in
additional information. An on-line form
is provided where the GPO’s members
can share their comments on the technology, and/or request that Novation
consider bidding or adding the technology to its portfolio of agreements, with
a link to the Novation bid calendar.
Other featured links include those to the
FDA and the Advanced Technology
Program of the U.S. Department of
Commerce.
“We believe this will offer us an opportunity to look at companies that may
offer technologies we may never have
been aware of,” says Denning.
Education process
A major part of Novation’s emphasis
on innovative technology is education.
“I educate smaller companies, innovative companies, and others about how
to participate in our bidding process and
how to work through our technology
IMDA Update
assessment group,” says Denning.
“We’re hopeful that the Technology
Forum will provide a consistent avenue
for us to obtain information from anybody out there who would like to submit a bid.”
She also says that Novation is educating third-party technology assessment companies about just what the
GPO is looking for. “A lot of these firms
look at technology assessment as space
planning, cost per procedure, cost/benefit,” she says. “But our needs are a little
different than that. Our technology assessment process looks at whether one
product offers benefits over another
from a patient-care or safety perspective, and whether it’s new, innovative
and better than what we’ve had.” Such
companies have to be educated as to
what Novation is seeking, she adds.
Boils down to contracts
Novation is seeking both consistency
and flexibility when it comes to innovative technologies, says Denning. “Consistency” in the sense of instituting a
standard protocol for assessing all new,
innovative technologies, and “flexibility” in the sense of accommodating technologies that emerge to contend with
those of existing Novation contract vendors. Hence the GPO’s pledge in its operating principles to re-bid product
agreements or add vendors to existing
agreements in the event that a new and
better technology emerges.
As part of the bid extension or re-bid
process, Novation’s contracting staff
routinely checks on the existence of new
technologies, and then decides whether
an existing agreement should be renewed or re-bid, or if other products
need to be added to the existing agreement, says Denning.
Clinical preference products
Because innovative technologies tend
to be clinician-sensitive, Novation has
taken an especially hard look at how it
contracts for clinical-preference products. In short, the GPO will strive to sign
dual- or multi-source awards for such
technologies whenever possible, except
where it’s not in the members’ best interest to do so.
The GPO’s recent contract for needles
and syringes demonstrates its new
approach.
While standard needles and syringes
may be commodities, safety products
remain clinically sensitive, concluded
the member council and task force that
orchestrated the agreement. For that
reason, they gave the contract for standard products to Kendall and BD, but
opened up the agreement for safety
products to those two suppliers as well
as Abbott Labs and Portex Inc.
In addition, Novation signed a contract in November with St. Jude Medical for its atrial fibrillation suppression
technology, a unique offering missing
from Novation’s pacemaker vendor contracts. “By identifying what are clinicalpreference items at the front end, we
are able to provide the evidence necessary for our councils and task forces to
think critically down the road,” says
Denning. 䡺
Promotions at CVC
Richard Manley, president and CEO of Arlington, TX-based CVC Inc.,
(cvcinc.com) announced the promotions of two of the company’s executives.
Bruce N. Cheatham, Jr. has assumed the responsibilities of chief operating
officer and will be accountable for overall operations of the company in the tenstate region that it serves. His responsibilities will also include supervision of
operations in the Arlington, TX, corporate headquarters and distribution facility. Since May 2000, Cheatham had been chief financial officer of CVC. As CFO,
he directed a plan that increased corporate profit and reduced debt, positioning
CVC to achieve the growth it has experienced over the last 18 months.
Meanwhile, Jack Burgess has been promoted to the position of executive
vice president, with responsibility for the company’s primary and secondary
sales forces. Burgess envisioned and implemented CVC’s new sales and marketing team, which now consists of eight primary sales representatives servicing acute healthcare facilities in 10 states. This group is supported by a secondary sales force expected to exceed 20 by year-end. Burgess has been with CVC
for over 10 years in a variety of sales, marketing and management positions.
CVC’s primary sales reps are the account managers and primary contact for CVC, while the secondary
sales force allows CVC to provide new technology and
procedures to smaller facilities, alternative care providers and to remote locations that previously were
poorly serviced by specialty companies, such as CVC.
3
January 2003
N · E · W
M · E · M · B · E · R
ERRY HINCHLIFFE may be new to IMDA, but not to specialty sales and marketing.
Hinchliffe and his wife, Joan, own Advanced Medical Systems Inc., Littleton, CO, a distributor of neonatal, labor
and delivery, respiratory and fall prevention equipment to hospitals; and patient lifts and tubs,
security systems and bed alarms
to long-term-care facilities.
Hinchliffe began his medical
career selling for Becton Dickinson on the East Coast. Eventually he became a product manager in the Vacutainer and needles/syringes division. After
10 years with BD, he was approached by a Colorado-based
company, Hemotec, a manufacturer of disposables and equipment used in open heart surgery. They were looking for an
East Coast regional manager. Hinchliffe took the job.
Three years later, the company brought him to Colorado as
national sales manager and director of sales and marketing.
One thing was certain: He had found something he liked —
Colorado. “We loved it here,” he says.
While at Hemotec, Hinchliffe had worked with independent dealers and reps, and liked what he saw. “So I decided
to give it a try.” He left the company and became an independent rep, calling primarily on OB/GYNs in their offices in a
four-state area. Then he moved into the hospital market, selling birthing beds. “That was our transition into the hospital,”
he says.
Hinchliffe’s young company made another transition — from
repping to distribution. “We had products for which we had
exclusive distribution. So if we did the work, we got the
rewards.”
Selling disposables forced Hinchliffe to improve his shipping and billing practices, That’s when Joan came into the
business. Today, she’s responsible for much of the inside work,
T
Joan and Terry Hinchliffe
such as payroll, accounts receivable, accounts payable and
customer service.
Their son, Craig, has held a sales territory in Colorado for
four years, and sells L&D, nursery and neonatal products.
Advanced Medical Systems has seven reps altogether, covering the states of Utah, Montana, New Mexico, Idaho, Wyoming, Nevada, Arizona, California and Colorado.
“We consider ourselves a niche company,” says Hinchliffe.
“We’re always looking for opportunities in the areas where
we have strength.”
He’s also looking forward to being a member of IMDA and
“learning how other companies became successful, and how
we as a group can work together on trends that seem to be
working away from small distributors.”
Hinchliffe can be reached at (303) 797-6123 or via e-mail at
[email protected]. 䡺
IMDA ANNOUNCEMENT
What Business Are You In?
Are you in the sales and marketing business, or the employee business?
Chances are, you started your company because you
loved selling and marketing innovative medical technologies. Yet, as your business has grown, you find yourself
spending less time on sales and marketing, and more time
taking care of people issues: Who’s entitled to what benefits? Is my employee manual up to date? What’s the policy
on maternity leave? How do I fire somebody without getting sued? How do I ensure my next hire is the right one?
And on and on.
Administaff is a professional employer organization that
can provide you with an outsourced human resources de-
partment. As an Administaff client, you still direct your
people to grow your business. What you don’t have to do,
however, is administer benefits and safety, and tend to all
the other HR tasks that you never thought about before,
don’t know how to do, and don’t particularly want to do.
IMDA and Administaff have signed a “Center of Influence” agreement, which entitles IMDA to a finder’s fee for
every member who signs up. At least two IMDA members
— Vital/Med Systems and Grandview Medical Resources
— have already done so.
To find out more about Administaff, visit the company’s
Website at www.administaff.com, or call IMDA headquarters at (800) 398-5632.
GET BACK TO BUSINESS. YOUR BUSINESS.
IMDA Update
4
January 2003
IMDA ANNOUNCEMENT
LETTER TO THE EDITOR
Last month, IMDA UPDATE published a list of “Questions for prospective principals,” that is, questions that specialty distributors and reps should ask manufacturers whose products they are considering selling. The following letter was
written by Debbie Kielman of IMDA’s insurance administrator (Schifman, Remley
and Associates) in response to the article.
Make a clear
case for
your value.
Forgot to ask one question:
You know that manufacturers of in-
Another important question/request of a potential supplier: Every distributor should request that their company name be shown as an additional
insured under the supplier’s product liability policy, and request a Certificate of Insurance evidencing current coverage. Being added to a supplier’s
policy is not possible in every situation, but it should be requested as part
of your due diligence. At the very minimum, current Certificates of product
liability insurance from the supplier should be maintained in the distributor’s
file. This is to the distributor’s benefit. Just as your hospitals and clients
ask to be provided with proof of your insurance, you should get same from
your manufacturers.
Debbie Kielman
Schifman, Remley and Associates
IMDA Insurance Administrator
novative devices save money by
outsourcing sales and marketing
rather than bringing on an expensive
direct sales force. But perhaps you
haven’t been able to prove it.
Relax, you don’t have to anymore.
Your manufacturers can do it themselves, with a tool developed for you
by IMDA.
This four-page brochure, titled
“It’s decision time,” is a worksheet
that manufacturers can fill out to actually compare the cost of going direct vs. that of outsourcing sales and
marketing. The worksheet prompts
them to compare the specialty
distributor’s or rep’s margin vs. the
costs of sales reps, sales managers,
administrative assistants, trade
shows, customer service reps, returned goods and all the other costs
of going direct.
This booklet should be an essential part of your marketing package.
It is available free to IMDA members.
Order copies today by calling IMDA
headquarters at (800) 398-5632 or via
e-mail at [email protected].
Stuffed supply chain
PPARENTLY, inventory stuffing
doesn’t occur only in the med/
surg business.
Drug maker Bristol-Myers Squibb is
in hot water for alleged “channel stuffing,” that is, convincing wholesalers to
buy more drugs than needed to meet
patient demand. According to The Wall
Street Journal, such efforts in 2001 cut
sharply into 2002 sales, as wholesalers
had too much product on hand.
The company announced in July 2002
that the Securities and Exchange Commission had begun investigating its
A
practices. The Justice Department followed suit in October.
More than dozen former employees
of Bristol-Myers have said that company
CEO and Chairman Peter Dolan knew
about efforts to bolster sales with
wholesaler incentives. Dolan himself
has refused to say what he knew about
the wholesalers’ inventory situation,
according to the newspaper report.
In October, Bristol-Myers said it
would restate its sales and earnings
going back at least as far as 2000, as a
result of the wholesaler practices. 䡺
REPRESENTATION NEEDED
Champion Manufacturing LLC
5406 Gwynne Road
Memphis, TN 38120
Contact ............................... Doug Keeslar
Phone ................................... (574) 295-6893
Fax ....................................... (574) 293-5760
E-mail .... [email protected]
Product: Medical treatment recliners,
sleeper chairs, loveseat sleeper,
stools, task chairs, and other seating products.
Do the
math!
Marketed to: Hospitals, clinics, longterm-care facilities, doctors’ offices.
Territory: Several.
IMDA Update
5
January 2003
GPO hosts Tech Forum
M
EDASSETS HSCA, the St. Louis-
based purchasing group,
opened its arms to developers
of new technologies by hosting a Technology Forum in conjunction with the
Medical Device Manufacturers Association, Washington, DC.
Eleven MDMA members, including
Masimo and Retractable Technologies—
two of the most outspoken critics of
GPOs — met to show their products to
dozens of materials managers that sit
on MedAssets HSCA’s advisory committee and whose organizations are
MedAssets HSCA members. Also on
hand were various clinicians, including
OR nurses, laboratory managers and
clinical resource managers.
“Our members evaluated some interesting products,” said Gene Banner,
senior vice president of contracting,
MedAssets. “The event allowed great
one-on-one interaction with the smaller
manufacturers that we likely would not
have received otherwise.” Banner says
he looks forward to hosting the event
again in the future.
GPOs faced a barrage of criticism in
2002 following a rash of unfavorable
articles in The New York Times and public hearings in front of the Senate Judiciary Subcommittee on Antitrust, Competition, and Business and Consumer
Rights.
In June 2002, MDMA called for GPOs
to adhere to a strict code of conduct,
which would prohibit them from (among
other things):
䡲 Asking for or accepting any type of
financial value or remuneration of any
form (such as administration fees,
marketing fees, advertising fees, research grants, etc.) from vendors.
䡲 Creating incentives for hospital purchasers to select certain products
over others through bundling or tying together unrelated products, or
directing or encouraging the use of
particular distributors of products.
䡲 Entering into private-label arrangements with manufacturers.
䡲 Entering into sole-source contracts
with manufacturers.
䡲 Discouraging or penalizing participating hospitals for evaluating or using
FDA REPORTS
DEVICE: DISTAL RADIUS FRACTURE REPAIR
SYSTEM
HAND INNOVATIONS INC.
510 STONEMONT DRIVE
WESTON, FL 33326
510(k) NO: K023007
DEVICE: ALPHA MIRAGE TOP TIGHTENING
SPINAL SYSTEM
ALPHATEC MANUFACTURING, INC.
6110 CORTE DEL CEDRO
CARLSBAD, CA 92009
510(k) NO: K023299
DEVICE: AUTOMED 3300 AND 3400 INFUSION
PUMP SYSTEM
HELP TECHNOLOGIES
24312 ARMADA DRIVE
DANA POINT, CA 92629
510(k) NO: K023491
DEVICE: TRELLIS RESERVE INFUSION SYSTEM
BACCHUS VASCULAR, INC.
3110 CORONADO DRIVE
SANTA CLARA, CA 95054
510(k) NO: K023514
DEVICE: JOWIRE NEO’S PTCA CATHETER
GUIDEWIRES
JOMED, INC.
15330 AVENUE OF SCIENCE
SUITE 200
SAN DIEGO, CA 92128
510(k) NO: K022762
DEVICE: EBI TARGETCATH FLUORO-GUIDED
STEERABLE CATHETER SYSTEM
EBI, L.P.
100 INTERPACE PKWY.
PARSIPPANY, NJ 07054
510(k) NO: K023233
IMDA Update
DEVICE: KSEA DEPLOYABLE CARDIOVASCULAR
CLAMP
KARL STORZ ENDOSCOPY-AMERICA
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600
510(k) NO: K014277
DEVICE: OLYMPUS PSD-20 ELECTROSURGICAL
SYSTEM AND ACCESSORIES
OLYMPUS OPTICAL CO. LTD.
TWO CORPORATE CENTER DRIVE
MELVILLE, NY 11747-3157
510(k) NO: K023280
6
great one-on-one interaction with the smaller
manufacturers that we
likely would not have
received otherwise.”
medical products or technologies that
are not on contract.
䡲 Entering into contracts with manufacturers that exceed two years in
duration.
䡲 Incorporating terms into their contracts that require a supplier to use
an e-commerce vendor (independent
or affiliated with the GPO) for the purpose of selling product, or else face
penalties. 䡺
The following list of devices receiving 510(k)
marketing clearance in the month of December
2002 was gathered from the FDA Website
at www.fda.gov/cdrh/510k/sumdec02.html.
DEVICE: MONSOON CRITICAL CARE JET
VENTILATOR AND ACCESSORIES
ACUTRONIC MEDICAL SYSTEMS AG
PO BOX 85820
TUCSON, AZ 85754-5820
510(k) No. K012691
DEVICE: REINFORCED ABSORBABLE SYNTHETIC
SURGICAL MESH
CENTER FOR BIOMATERIALS AND ADVANC
11800 BALTIMORE AVE.NUE
SUITE 105
BELTSVILLE, MD 20705
510(k) NO: K023328
“The event allowed
DEVICE: NON-BIOABSORBABLE STAPLE
ONUX MEDICAL INC.
5 MERRILL DRIVE
HAMPTON, NH 03842
510(k) NO: K023372
DEVICE: PEDIATRIC ARTERIAL CANNULA
POLYSTAN A/S
WALGERHOLM 8
VAERLOSE, DENMARK DK-3500
510(k) NO: K023251
DEVICE: FEMOSTOP FEMORAL COMPRESSION
SYSTEM
RADI MEDICAL SYSTEMS AB
PALMBLADSGATAN 10
UPPSALA, SWEDEN S-754 50
510(k) NO: K024107
DEVICE: SPECTRUM CERVICAL SPINAL SYSTEM
SPINAL INNOVATIONS LLC.
7850 STAGE HILLS BLVD.
SUITE 105
BARTLETT, TN 38133-4029
510(k) NO: K022997
DEVICE: ADAPT BALLOON OPEN ACCESS PORT,
MODEL 41244
TAUT INC.
2571 KANEVILLE COURT
GENEVA, IL 60134
510(k) NO: K023261
January 2003
EP MedSystems (West Berlin, NJ)
submitted its ViewMate™ intracardiac
ultrasound catheter system product
dossier to the European Notified Body
for regulatory approval. Approval is
sought to affix the CE mark onto the
product, allowing sale of the system to
the European Community. The intracardiac ultrasound catheter system consists
of an ultrasound imaging console with
an image monitor, and a thin, disposable catheter fitted with a 64-element
phased-array transducer on its tip. The
system is said to allow cardiologists and
electrophysiologists to optimally view
the interior anatomy of the heart.
EP MedSystems also announced that
it received market clearance notification
from the U.S. Food and Drug Administration for its ALERT® System, a catheter system used for treating atrial fibrillation (an irregular rhythm of the
heart). ALERT delivers programmable,
low-energy, bi-phasic electrical impulses directly to the inside of a patient’s
heart to convert atrial fibrillation to a
normal rhythm. The electrical impulses
are delivered via the ALERT® catheter,
which is used in tandem with an energy
source called ALERT® Companion.
(www.epmedsystems.com)
Hatch Medical LLC (Snellville, GA),
a medical device incubator and technology brokerage firm, entered into an
agreement with HB Technology LLC to
broker, with an option to manufacture,
the company’s patented core-tissue biopsy instrument. HB Technology’s device is said to incorporate proprietary
design elements and proven core-tissue
biopsy technology to produce a minimally invasive device that yields histological tissue samples. For additional
information on this or other Hatch Medical products and services, e-mail the
company at [email protected].
Lumenis Inc. (Santa Clara, CA) said
that its Novus Varia multicolor photocoagulation laser system received mar-
IMDA Update
keting approval from the FDA for the
treatment of a range of retinal diseases.
The system is said to be the world’s first
solid-state, multi-wavelength ophthalmic laser to operate on any standard
electrical outlet. (www.lumenis.com)
Merit Medical Systems (South Jordan, UT) received FDA clearance to
market its new safety needle, the
Majestik™ Shielded Needle. The potential market for the needle is approximately 10 million angiography procedures each year worldwide, according
to the company. Angiography needles
are used specifically for vascular access,
usually to a patient’s femoral artery during a diagnostic or therapeutic procedure. The hollow needle provides an
opening through which other devices
such as guide wires can be placed. Merit
Medical’s shielded needle design involves a one-piece molded part that
folds down over the needle tip following removal.
(www.merit.com)
Norwood Abbey said that it developed a needle-less injection device in
conjunction with the Massachusetts Institute of Technology. The company says
the new device is an improvement on
existing needle-less technologies as it
uses a new propulsion system, allowing it to deliver doses without the associated sound common in other devices.
The drug is delivered through the skin
using a small hand-held device. The system uses a patented contractile fibreactivated pump, which fires the drug at
the skin with sufficient velocity to penetrate without the use of needles. The
drug vial is designed as a single-use disposable, which is inserted into the portable applicator device. Existing needleless injection devices typically use either
compressed gas or, via a fast chemical
reaction, produce a gas to force a fixed
quantity of drug out through a small orifice at a velocity that is high enough to
penetrate skin.
(www.norwoodabbey.com)
Medtronic Inc. (Santa Rosa, CA) said
that its Bridge Extra Support Balloon
Expandable Stent system has received
approval from the FDA for the treatment
7
of renal artery stenosis, which is a blockage in the vessels of the kidneys. Physicians can use the stent to help prop open
renal vessels that remain blocked by a
sub-optimal balloon angioplasty procedure. The system for renal artery stenosis also recently received licensure from
the Therapeutics Products Directorate in
Canada, and is now available for treating this indication in the U.S., European
and Canadian markets.
Meanwhile, Medtronic also announced that the FDA cleared for marketing its Medtronic Magellan™ Autologous Platelet Separator. The system is
said to process surgical patients’ own
blood in a manner that can help patients
in a variety of ways, including elimination of uncomfortable, inconvenient
drains and reducing the risk of infection.
The separator uses density differences
and gentle centrifugal forces to separate
platelet-rich plasma containing important growth factors from a blood sample,
and deposits these components into a
separate sterile syringe.
(www.medtronic.com)
Smith & Nephew Inc., Endoscopy Division (Andover, MA) introduced an enhanced version of its Dyonics™ Access
15 Arthroscopic Irrigation System, a
fluid distension system for use in articular cavities for diagnostic and operative
arthroscopic procedures. It contains a
software package providing Advanced
Flow Regulation for optimal flow performance and pressure maintenance.
Smith & Nephew’s Endoscopy Division also introduced its Decompression
Catheter, a heat-based procedure for
lower back and leg pain associated with
bulging or contained herniated discs.
Prescribed for symptomatic patients
who have failed conservative treatments
such as physical therapy, medication
and rest, the decompression procedure
uses thermal technology to modify
nuclear tissue and relieve the pressure
the herniation was creating on the spinal nerve root.
The procedure is performed on an
outpatient basis under local anesthesia,
taking approximately 40 minutes, according to the manufacturer.
(www.endoscopy1.com)
January 2003
update
President ........................ Dave Campbell
President-Elect ..........Bob Wahlenmaier
Treasurer............................Ed Boracchia
Secretary ........................ Tim McInerney
Director-at-Large .......... Stan Tangalakis
Immediate
Past-President........... Richard Manley
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Membership Services Director
The ideas presented in this newsletter
may or may not be applicable to your
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Mark Thill
Editor & Communications Director
847/255-0716
IMDA Update
2002-2003 Directors
of the Association:
8
January 2003