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[IN] HEA MTC BIO
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-- WITH PHOTO -- TO BUSINESS, HEALTH, AND MEDICAL EDITORS:
American Heart Association Honors Dr. Jack Copeland, Total Artificial
Heart Pioneer
TUCSON, Ariz., March 4, 2014 /PRNewswire/ -- Internationally renowned
heart transplant pioneer Dr. Jack G. Copeland was honored recently as
a "Heart Hero" by the American Heart Association in Tucson, Arizona,
for his trailblazing work saving lives with heart transplantation, the
SynCardia temporary Total Artificial Heart and the use of heart assist
devices.
-- Watch tribute to Dr. Copeland video
http://www.syncardia.com/news/american-heart-association-honors-dr-jack-copeland/itemid-1683.html
In his 33 years as head of the cardiothoracic surgery program at the
University of Arizona Medical Center (UAMC) in Tucson, Copeland
performed Arizona's first heart transplant (1979) and its first
heart-lung transplant (1985). He also conducted the first U.S. implant
of a pediatric ventricular assist device designed for newborns and
toddlers (2000).
In 1985 he became the first surgeon to use the Jarvik 7 artificial
heart, an early version of the SynCardia Total Artificial Heart, to
successfully bridge a patient dying from end-stage heart failure to a
donor heart transplant. Without the Total Artificial Heart or an
immediate donor heart transplant, the patient would have died. The
first five implants of the Jarvik 7 were implanted as permanent
replacement hearts.
Copeland was driven by his desire to save patients. He needed to have
an option if a transplanted donor heart failed to restart. For close
to 30 years he turned that need into a lifesaving reality through the
use and refinement of the SynCardia Total Artificial Heart. His
countless contributions to the Total Artificial Heart include
advancing surgical techniques, patient care protocols and
anticoagulation (blood) management.
According to data published in the New England Journal of Medicine
from the 10-year pivotal clinical study that led to FDA approval, 79%
of patients who received the Total Artificial Heart were bridged to
transplant. This is the highest bridge to transplant rate for any
approved heart device in the world. Copeland served as Principal
Investigator for that study.
While at UAMC, Copeland was involved in more than 100 SynCardia Heart
implants. In 2001, he, biomedical engineer Richard G. Smith and Dr.
Marvin J. Slepian formed SynCardia Systems, Inc. in order to
commercialize the SynCardia Heart. The company is the privately held
manufacturer of the SynCardia Total Artificial Heart, the first and
only FDA, Health Canada and CE approved Total Artificial Heart in the
world.
Nearly 1,300 SynCardia Hearts-about 300 in the last 26 months-have
been implanted worldwide, accounting for more than 350 years of
patient support. The 13.5-pound Freedom@ portable driver that powers
the SynCardia Heart is Health Canada and CE (for Europe) approved with
FDA approval pending. The wearable Freedom portable driver is one of
the biggest advances for the SynCardia Heart; it allows clinically
stable patients to recover at home while they wait for their donor
hearts.
Patients without human hearts are able to eat home-cooked meals, sleep
in their own beds and socialize in their community. Most patients
exercise to get their bodies in better shape for their heart
transplants. One patient hiked 607 miles with his Freedom portable
driver before his successful heart transplant.
"We thank Dr. Copeland for his tremendous contributions that provide
end-stage biventricular heart failure patients a second chance at
life," says Michael P. Garippa, SynCardia's CEO and President. "The
SynCardia Total Artificial Heart saves lives and the Freedom portable
driver provides nearly unrestricted mobility to help patients enjoy a
life worth living."
Copeland's ongoing contributions continue to expand the benefits of
using the SynCardia Heart.
A 50cc Total Artificial Heart is in development and awaiting FDA
approval for a clinical study. It is intended for adults of smaller
stature and adolescents and will triple the population who can use the
Total Artificial Heart. Both sizes will make SynCardia Hearts
available to almost all adults and many adolescents.
SynCardia also is working with the FDA to make the SynCardia Heart
available for "destination therapy" (permanent use). Approval will
allow up to 4,000 U.S. patients annually to receive the SynCardia
Total Artificial Heart as a permanent replacement heart.
Dr. Copeland co-founded and served as one of the first presidents of
the International Society of Heart & Lung Transplantation, the first
trade association of its kind that brings together the best
practitioners in transplantation, mechanical support and innovative
therapies that improve the care of patients with advanced heart and/or
lung disease. His life's work was recognized when ISHLT honored him
with the 2013 Pioneer in Transplantation Award.
Today Copeland is a cardiothoracic surgeon at University of
California, San Diego. As one of SynCardia's surgical proctors, he
helps the world's finest heart transplant centers perform their first
SynCardia Heart implants. There are 97 SynCardia Certified Centers
with 39 hospitals in the process of certification.
The 50cc Total Artificial Heart is designed for use as a bridge to
transplant in patients of smaller stature, including women and
adolescents. It has been designated as a Humanitarian Use Device (HUD)
by the FDA for destination therapy in adults and as a bridge to
transplant in pediatric patients. Prior to clinical study, an
Investigational Device Exemption (IDE) application that includes each
indication must be approved by the FDA.
CAUTION - The Freedom portable driver is an investigational device,
limited by United States law to investigational use.
About the SynCardia temporary Total Artificial Heart
Photo - http://photos.prnewswire.com/prnh/20140304/LA75986
SOURCE SynCardia Systems, Inc.
-0- 03/04/2014
/CONTACT: Don Isaacs, VP of Communications, SynCardia Systems, Inc., Cell: (520) 955-0660, disaacs@syncardia.com
/Photo: http://photos.prnewswire.com/prnh/20140304/LA75986
PRN Photo Desk, photodesk@prnewswire.com
/Web Site: http://www.syncardia.com
CO: SynCardia Systems, Inc.
ST: Arizona
IN: HEA MTC BIO
SU: AWD
PRN
-- LA75986 --
0000 03/04/2014 14:00:00 EDT http://www.prnewswire.com
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