FDA Approved Artificial Hearts
SynCardia temporary Total Artificial Heart
The SynCardia temporary Total Artificial Heart (formerly known as the CardioWest TAH), manufactured by SynCardia Systems, Inc. was the first FDA-approved total artificial heart. It received FDA approval on October 15, 2004, following a 10-year clinical study.
Originally designed as a permanent replacement heart, it is currently approved as a bridge to donor heart transplant for patients dying because both sides of their hearts are failing (irreversible, end-stage biventricular failure). SynCardia claims there are more than 1000 implants of the Total Artificial Heart, accounting for more than 270 patient years of life on this device. During the 10-year pivotal clinical study, 79% of patients receiving the Total Artificial Heart survived to transplant (New England Journal of Medicine 2004; 351: 859–867). This is the highest bridge-to-transplant rate for any heart device in the world.
In 2010, SynCardia’s Freedom portable driver, the world's first wearable power supply for the Total Artificial Heart, received the CE Mark for use in Europe and FDA approval to undergo an Investigational Device Exemption (IDE) clinical study in the U.S. Weighing 13.5 pounds (6.1 kilograms), the Freedom driver allows stable Total Artificial Heart patients who meet discharge criteria to leave the hospital and resume their lives at home and in their communities while they wait for a matching donor heart. On April 24, 2012, SynCardia completed the minimum enrollment required by the clinical study. The company plans to submit the Freedom portable driver for FDA approval through a post-market approval supplement in Q4 2012.
According to SynCardia, the longest a patient has been supported with the Total Artificial Heart is 1,374 days (nearly four years) before he received a successful heart transplant.
AbioCor Replacement Heart
Unlike the CardioWest TAH, the AbioCor Replacement Heart by AbioMed is fully implantable, meaning that no wires or tubes penetrate the skin, and, therefore, there is less risk of infection.
The AbioCor is approved for use in severe biventricular end-stage heart disease patients who are not eligible for heart transplant and have no other viable treatment options. As of April 2011, 14 patients have been implanted with the AbioCor, with one patient living for 512 days with the AbioCor.
The AbioCor received FDA approval under a Humanitarian Device Exemption (HDE) on September 5, 2006. The first implant of the AbioCor since receiving FDA approval in 2006 took place on June 24, 2009, at Robert Wood Johnson University Hospital, New Brunswick, New Jersey. This patient later died on August 23, 2009. (See FDA Summary of Safety and Probable Benefit.) Abiomed is no longer actively marketing the AbioCor. In a November 2009 article in the Boston Globe, Abiomed’s CEO Mike Minogue said, “I consider this thing the sports car you watch on television, but you can’t buy from your dealer.”
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