An artificial heart is a mechanical device that is implanted into the body to replace the biological heart.
The term “artificial heart” has often inaccurately been used to describe ventricular assist devices (VADs), which are pumps that assist the heart but do not replace it.
An artificial heart is also distinct from a cardiopulmonary bypass machine (CPB), which is an external device used to provide the functions of both the heart and lungs. CPBs are only used for a few hours at a time, most commonly during heart surgery.
FDA Approved Artificial Hearts
CardioWest temporary Total Artificial Heart
The CardioWest temporary Total Artificial Heart (TAH-t) (SynCardia Systems, Inc.) is the world’s first and only FDA-approved Total Artificial Heart. It received FDA approval on Oct. 15, 2004, following a 10-year pivotal clinical study.
Originally designed as a permanent replacement heart, it is currently approved as a bridge to human heart transplant for patients dying because both sides of their hearts are failing (irreversible end stage biventricular failure). There have been more than 780 implants of the CardioWest artificial heart, accounting for more than 150 patient years of life on this device.
In the 10-year pivotal clinical study of the CardioWest artificial heart 79% of patients receiving the 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. See
AbioCor Replacement Heart
The AbioCor Replacement Heart (Abiomed) received FDA approval under a Humanitarian Device Exemption (HDE) on Sept. 5, 2006. 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. The AbioCor has been implanted 14 times. The most recent implant was May 24, 2004. See FDA Summary of Safety and Probable Benefit
0 comments:
Post a Comment