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.

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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.