* While patients are implanted with the AB5000 with the goal of recovering the heart, there have been some instances in which, after giving a patient's heart a full opportunity to recover, doctors have determined that recovery will not occur. Nearly thirty percent of survivors have received heart transplants after it was determined that native heart function would not return; their average duration of support on the AB5000 was nearly 40 days.
* 20 percent of all AB5000 patients were supported following AMI-
* 47 percent of all AB5000 patients required support on both sides of the heart.
* Nineteen patients have ambulated while on AB5000 support, walking
hospital grounds as well as using treadmills and stationary bicycles.
The AbioCor is the world’s first completely self-contained replacement heart. A product of three decades of research, development and testing, the AbioCor is central to ABIOMED’s mission to make real the day when heart failure need not mean the end of life or the ability to enjoy life. Designed to fully sustain the body's circulatory system, the AbioCor is intended for end-stage heart failure patients whose other treatment options have been exhausted.
In 2001, ABIOMED made history when Mr. Robert Tools, a 58-year-old telephone company employee and teacher suffering from end stage heart failure was successfully implanted with the first AbioCor. The initial clinical trial is continuing with the aim of gaining approval to market the AbioCor to support patients with irreversible end-stage heart failure. The company also recently submitted to the FDA for commercial approval for the AbioCor under a Humanitarian Device Exemption.
ABIOMED is also working on the next generation implantable replacement heart, the AbioCor II. Incorporating technology both from ABIOMED and Penn State, the AbioCor II is smaller and is being designed with a goal of five year reliability.