Record Number of ISHLT Abstracts Discuss SynCardia’s Total Artificial Heart

April 5, 2012

Medical meeting presentations to include post-market surveillance study results and comparison of survival to transplant/INTERMACS profile among MCS devices.

Tucson, AZ (PRWEB) April 05, 2012

SynCardia Systems, Inc., manufacturer of the world´s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that this year´s annual meeting of the International Society for Heart & Lung Transplantation (ISHLT) being held April 18-21 in Prague, Czech Republic, features a record number of abstracts discussing the SynCardia temporary Total Artificial Heart.

“With more than 1,000 implants, use of the Total Artificial Heart worldwide is accelerating rapidly. During Q1, 26 hospitals implanted the Total Artificial Heart, 12 of which were new centers,” said Michael Garippa, SynCardia Chairman/CEO/President. “The number of ISHLT presentations is a testament to the growing acceptance of the Total Artificial Heart as the new standard of care for end-stage biventricular heart failure.”

Two key ISHLT presentations discussing the SynCardia Total Artificial Heart include:

Session: Mini Oral Session: 4 Mechanical Circulatory Support II (1:15-2:45 p.m.)

Date/Time: Friday, April 20 — 2:20 p.m.

Location: Panorama Hall

Purpose: The Total Artificial Heart (SynCardia Systems) was approved in the U.S. by the FDA in 2004 as a bridge-to-transplantation (BTT) for patients at imminent risk of death from irreversible biventricular failure. The original PMA study leading to regulatory approval was conducted from 1993 — 2002 at 5 medical centers with 58/81 (78%) of TAH implants performed at a single center. A BTT rate of 79.9% was achieved. The question remains as to the translatability of this outcome, and the general facility of use of the TAH, in the hands of multiple surgeons, across varying implanting medical centers. We report the results of the FDA-required post-market surveillance study (PMSS) examining the efficacy of the TAH in general use across the U.S.

Session: Concurrent Session 43: VAD Bad (11:30 AM-12:45 PM)

Date/Time: Saturday, April 21, 2012 – 11:42 AM

Room: Meeting Hall I

Purpose: Bi-ventricular support has historically shown poorer survival to transplant than LVAD alone. Survival studies, however, have generally not distinguished between those supported with the Total Artificial Heart (TAH) and other strategies for bi-ventricular support (BiVAD). This study compares survival to transplant among patients receiving BTT using BiVAD, LVAD or TAH support.

During ISHLT, on April 20, SynCardia is holding a Clinical Investigator´s Meeting for the Freedom® portable driver, the world´s first wearable power supply for the Total Artificial Heart. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

Caution — The Freedom® portable driver is an investigational device, limited by United States law to investigational use.


About the SynCardia temporary Total Artificial Heart

SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world´s first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart“¦ read more

For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/4/prweb9372740.htm

Source: prweb

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