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AHA-Tucson Division Names SynCardia Co-Founder Copeland a Heart Hero for His Pioneering Work With Heart Transplants & the SynCardia Total Artificial Heart


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[STK]

[IN] HEA MTC BIO

[SU] AWD

-- 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

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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