Freedom® Portable Driver

For patients dying from end-stage biventricular
heart failure, there are only two options:
1. An immediate donor heart transplant, availability uncertain.
Both failing
ventricles
are removed.
2. The SynCardia temporary Total Artificial Heart as a bridge to transplant,
immediately available at SynCardia Certified Centers.
Donor Hearts: Only 3,500 Available Worldwide Annually
Quick connects are
sewn into the atria,
aorta and pulmonary
artery.
The Total Artificial
Heart (TAH) is implanted
and attached via four
quick connects.
When a donor heart
becomes available,
the TAH and quick
connects are
removed.
Europe Donor Heart Transplants
# of Donor Heart Transplants
2500 –
2000 –
1500 –
1000 –
500 –
0–
90
95
00
Year
05
2000 –
1500 –
1000 –
500 –
0–
10
010203 0405 0607 08
Year
Despite growing demand worldwide, only 3,500 donor hearts become available annually.
It is estimated that each year, up to 100,000 people in the U.S. alone could benefit
from mechanical circulatory support devices such as the SynCardia Total Artificial Heart.
SynCardia Total Artificial Heart
Originally used as a permanent replacement heart, the Total Artificial Heart is currently
approved as a bridge to transplant for transplant-eligible patients at risk of imminent
death from biventricular failure. It is the world’s first and only FDA, Health Canada and
CE approved Total Artificial Heart.
Bridge to Second Transplant
The SynCardia Total Artificial
Heart is the only device that
allows surgeons to remove the
failing transplanted heart and
stop immunosuppressant
medication until a second
matching donor heart can be
transplanted.
Survival Curve After Heart Transplantation
100
80
Survival (%)
The atria, aorta
and pulmonary
artery remain
intact.
US Donor Heart Transplants
2500 –
# of Donor Heart Transplants
The four
native valves
are removed.
60
40
20
N = 66,751
0
Years 0
4
8
12
16
21
Source: Journal of the American College of Surgery 2006; 203(2): 226-39.
The donor
heart is
transplanted.
“I have witnessed several patients who needed a second transplantation,
but died before a donor heart became available. Those patients would
have been excellent candidates for an immediately-available heart.
The Total Artificial Heart is the only device that allows us to remove the
failing donor heart completely and bridge patients to a second transplant
without immunosuppressive therapy.”
David Luís Simón Morales, MD
2
Executive Co-Director, The Heart Institute
Professor and Endowed Chair of Pediatric Cardiothoracic Surgery
Chief, Pediatric Cardiothoracic Surgery
Cincinnati Children’s Hospital Medical Center
The University of Cincinnati College of Medicine
SynCardia temporary
Total Artificial Heart
Human Heart
Similar to a heart transplant, the SynCardia Total Artificial Heart
is the only device that:
Eliminates the symptoms & source of end-stage biventricular heart failure
Replaces both failing ventricles
Replaces all four heart valves
Eliminates native heart complications
No ventricle dysfunction/failure
No diseased heart valves
No arrhythmias or need for pacemaker/defibrillator
Provides immediate, safe blood flow up to 9.5 L/min through each ventricle
Immediately restores normal Cardiac Index (CI)
Immediately restores normal Central Venous Pressure (CVP)
Overcomes high Pulmonary Arterial Pressure (PAP)
Restores normal hemodynamics and organ perfusion
Unlike a donor heart, the SynCardia Total Artificial Heart
Is immediately available at SynCardia Certified Centers
Does not require expensive, immunosuppressant medication, which can cause subsequent complications
Mr. Okeke received his first heart transplant at age 30 after a blood clot damaged
his coronary artery. Thirteen years later, his body began rejecting his donor heart and he was
implanted with the Total Artificial Heart. Since receiving his second heart transplant in January 2011,
Mr. Okeke has been enjoying life at home with his wife Natalie and their three young children.
Charles Okeke
UNITED STATES
Implanted: Sept. 3, 2008
Freedom® discharge: May 3, 2010
Transplanted: Jan. 15, 2011
CAUTION - The Freedom® portable driver is an investigational device, limited by United States law to investigational use.
3
Patients Recover Rapidly with the SynCardia Total Artificial Heart
According to March 2011
INTERMACS data,
72% of Total Artificial
Heart patients were
transplanted at 6 months
and 75% at 12 months.
Safe Blood Flow Up to 9.5 Liters per Minute
The Total Artificial Heart is the only device that provides immediate,
laminar blood flow of up to 9.5 liters per minute through each ventricle.
Implanting the Total Artificial Heart helps
make patients healthier transplant candidates:
Previous reports have shown that
almost all Total Artificial Heart patients
were classified in the two sickest INTERMACS
categories prior to implant, yet the SynCardia
Total Artificial Heart had the highest bridge to
transplant rate of all the devices tracked in INTERMACS.
Immediately increases Cardiac Index (CI)
n Immediately restores normal Central Venous Pressure (CVP)
n
n
French Total Artificial Heart
patient Mr. Lediouron
pictured at home with the
Freedom® portable driver in
Sept. 2010 with his wife
Karene and their two
daughters, Wendy
and Sidney.
Resuscitates kidneys, liver, GI tract, brain, other vital organs
Overcomes high Pulmonary Arterial Pressure (PAP)
n Restores normal hemodynamics and organ perfusion
n
Christian Lediouron
FRANCE
Implanted: May 17, 2010
Freedom® discharge: June 30, 2010
Transplanted: March 3, 2011
In comparison, approximately 25% of patients with other
mechanical circulatory support devices were classified in less
sick categories prior to implant.
Data from the 10-year pivotal clinical study of the Total Artificial Heart, published in the New England Journal of Medicine
(N Engl J Med 2004; 351:859-867)
Immediate Increase in Cardiac Index
Organ Recovery at Two Weeks
Physical Recovery
Liver function had returned to normal at two weeks
Post-Operative Day 5: Approximately 65% of the
core Total Artificial Heart patients were out of bed.
Bridging the Sickest Patients to Transplant
Highest bridge to transplant rate: Survival to transplantation was
achieved in 79% of patients who received the SynCardia Total Artificial
Heart according to protocol, as compared with 46% of the controls who
did not receive the device. This is the highest bridge to transplant rate of
any approved heart device.
Overall survival: The one-year survival rate among patients who received
the Total Artificial Heart was 70%, as compared with 31% among the
controls. One-year and five-year survival rates after transplantation
among patients who had received the Total Artificial Heart were
86% and 64%.
Prior to implant, patients in need of the Total Artificial Heart had a
baseline cardiac index of 1.9 L/min/m2.
Immediately following implant, the patient’s cardiac index
increased to an average of 2.9 L/min/m2.
4
Kidney function had improved significantly, trending to normal
Post-Operative Day 14: 60% of core Total Artificial
Heart patients were walking more than 100 feet.
5
Additional Benefits of the
SynCardia Total Artificial Heart
No right ventricular dysfunction/failure
No acquired von Willebrand syndrome (AVWS) reported
Right Ventricular Dysfunction/Failure after LVAD Implant
HeartWare HVAD - ADVANCE Clinical Study Results
22%
The SynCardia Total Artificial Heart powered
by the Freedom® portable driver
of patients developed right heart failure requiring either a
Right Ventricular Assist Device (RVAD) or inotropic support*
HeartMate II LVAD - Pre-Market Approval Results
19%
of patients developed right heart failure during the
pre-market approval of the HeartMate II**
*Source: Evaluation of the HeartWare HVAD Left Ventricular Assist System for the Treatment of
Advanced Heart Failure: Results of the ADVANCE Bridge to Transplant Trial; Keith Aaronson,
Mark Slaughter, Edwin McGee, et al. for the HeartWare ADVANCE Investigators; American Heart
Association Scientific Sessions November 2010
**Source: HeartMate II FDA Summary of Safety and Effectiveness
http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060040b.pdf
“Acquired von Willebrand syndrome in patients with
ventricular assist device or total artificial heart”
Left ventricular assist device (LVAD)
Authors: C. Heilmann, U. Geisen, F. Beyersdorf, L. Nakamura, C. Benk, M. Berchtold-Herz,
G. Trummer, C. Schlensak, B. Zieger; University Medical Center Freiburg, Freiburg, Germany
Published in Thrombosis and Haemostasis 2010 103 5: 962-967
Summary:
“Unexplained bleeding episodes are associated with ventricular assist devices (VAD) and can occur in part due to
acquired von Willebrand syndrome (AVWS)… We studied 12 patients who required mechanical support of their
native heart for terminal cardiac insufficiency. Nine patients underwent placement of a VAD, while three
underwent placement of a total artificial heart (TAH)…
AVWS was present within two weeks of implantation in eight of nine patients… AVWS was not observed in the
TAH patients studied. Our findings demonstrate that patients with an implanted VAD experience a rapid onset
of AVWS that is quickly and completely reversed after device explantation.”
Prof. Dr. Friedhelm
Beyersdorf, Director of
Cardiovascular Surgery
at University Medical
Center Freiburg,
Germany
On July 22, 2011, Shawn Galloway became the first of four patients
to receive the Total Artificial Heart at Texas Heart Institute during a 12-day period.
A month after her surgery, she was discharged home to wait for a matching donor heart with
her husband Joel and their daughter Hannah. She received her heart transplant on Sept. 20, 2011.
Shawn Galloway
UNITED STATES
Implanted: July 22, 2011
Freedom® discharge: Aug. 23, 2011
Transplanted: Sept. 20, 2011
CAUTION - The Freedom® portable driver is an investigational device, limited by United States law to investigational use.
6
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Jordan Merecka, 18, was the first pediatric SynCardia Total Artificial Heart patient to
be discharged from Texas Children’s Hospital to wait for a matching donor heart at
home using the Freedom® portable driver. Jordan, pictured with his mother Suzanne, received
his donor heart transplant on Oct. 29, 2011, after 160 days of life with the Total Artificial Heart.
Jordan Merecka
UNITED STATES
Implanted: May 22, 2011
Freedom® discharge: Aug. 31, 2011
Transplanted: Oct. 29, 2011
SynCardia Drivers Power the Total Artificial Heart
The Companion 2 “launch” driver powers the Total Artificial Heart in the hospital from the operating room implant until the patient’s
condition stabilizes. Stable patients who are eligible are then switched to the Freedom® portable driver for in-hospital ambulation
and home discharge*.
Companion 2 Hospital Implant Driver
CE approved for use in Europe
FDA approved for use in the U.S.
Design Features:
n Runs on hospital air for quieter operation
n Runs on internal compressors for improved mobility
n Longer service life
User-friendly touchscreen provides access to
all driver functions… no keyboard required
The Companion 2 driver can be docked in the Hospital Cart during patient recovery
and the Caddy for in-hospital ambulation.
Three Operating Modes
n Operating Room – all features and functions are available
n Intensive Care Unit – full access to alarm modes and
monitoring of critical functions
n Ambulatory – heart rate & drive pressures need no adjustment
Freedom® Portable Driver
CE approved for discharge in Europe
April 2012: Enrollment completed in FDA-approved
Investigational Device Exemption (IDE) clinical study
n
n
n
n
World’s first wearable power supply for the Total Artificial Heart
Weighs 13.5 lbs ( ~6 kg) including two onboard rechargeable batteries
Designed to be carried by the patient in the Freedom Backpack or Shoulder Bag
Batteries are charged using a standard electrical outlet or
car cigarette lighter adaptor
*CAUTION – The Freedom® portable driver is an investigational device,
limited by United States law to investigational use.
Companion 2 and Freedom drivers are serviced by replacement
No on-site repair required
n No inventory of parts required
n
The Freedom® portable driver with the
SynCardia temporary Total Artificial Heart
French Total
Artificial Heart
patient Mr. Amoussou,
pictured in September 2010,
carries his Freedom® portable
driver in the Shoulder Bag.
Antonio Amoussou
FRANCE
Implanted: Feb. 16, 2010
Freedom® discharge: July 5, 2010
Transplanted: Jan. 2, 2011
7
30 Years of Proven Reliability
Longest supported Total Artificial Heart patient, 1,374 days
(nearly 4 years) prior to transplant
1,000+ implants of the Total Artificial Heart account for more than 270 patient years of life
The valves in the Total Artificial Heart have never failed
The diaphragm has a failure rate of less than 1% over 2,000+ diaphragms
SynCardia Products Under Development
CAUTION - The Permanent Total Artificial Heart, 50cc Total Artificial Heart and Freedom® 2 prototypes are not for human use. These products
are in the research and development phase and will not be ready for sale in the U.S. or Europe until after all regulatory requirements have been met.
Permanent Total Artificial Heart
n
n
n
n
Intended for patients with a Body Surface Area (BSA) of 1.7m2 or greater
On March 2, 2012, the FDA approved a Humanitarian Use Device (HUD) designation
for the Total Artificial Heart to be used on a permanent basis.
SynCardia is currently working on submitting a Humanitarian Device
Exemption (HDE) to the FDA.
Once approved, the HDE will allow up to 4,000 U.S. patients annually who are not
transplant-eligible to receive the Total Artificial Heart on a permanent basis.
70cc SynCardia Total Artificial Heart
New 50cc Total Artificial Heart
n
n
n
Intended for patients with a BSA of 1.2 to 1.7m2
Designed for women, men of smaller stature and adolescents
Together, the 70cc and 50cc Total Artificial Hearts are designed to fit almost all
adult men and women, and most adolescents.
50cc SynCardia Total Artificial Heart
Freedom® 2 Portable Driver (In-hospital ambulation & home discharge)
Intended Design Features:
n Lighter and easier to carry
n Quieter operation for improved quality of life
n Longer service life
Freedom® 2 Portable Driver
For information about becoming a SynCardia Certified Center, contact:
VP of Global Certification & Logistics
Mary Pat Sloan +1 520 440-7593 | [email protected]
1992 East Silverlake Rd. | Tucson, AZ 85713
Managing Directors
Dr. Oliver Voigt & Markus Leinberger | [email protected]
+49 700 SYNCARDIA (796227342)
World’s Longest Supported Total Artificial Heart Patient
Mr. Zorzetto, wearing the Freedom® portable driver in the Backpack, is the world’s longest supported
Total Artificial Heart patient at 1,374 days. He received a matching donor heart after nearly 4 years of support.
Pietro Zorzetto
www.syncardia.com
ITALY
Implanted: Dec. 6, 2007
Discharged: Feb. 4, 2008
Transplanted: Sept. 9, 2011