Abiomed, Inc. announced that it has received U.S. Food and Drug Administration (FDA) Humanitarian Device Exemption (HDE) supplement approval on system upgrades for its AbioCor Implantable Replacement Heart (AbioCor). The AbioCor is intended to replace the severely damaged native heart for patients who are not eligible for a transplant and have no other treatment alternative.
The AbioCor sustains the body's circulation and is designed to extend the lives of patients who would otherwise die of heart failure, while also offering a probable benefit for a satisfactory quality of life. The AbioCor is the first completely self-contained artificial heart that may allow patients more time at home, without wires or tubes piercing through their skin, reducing the chance of infection. Its remote diagnostics allow patients to return home where they can resume normal activities including bathing. The AbioCor is able to pump blood through the body, simulating the rhythm of a heartbeat. The complete AbioCor system consists internally of a thoracic unit, a rechargeable battery, a miniaturized electronics package, a power receiver coil, and externally, a power transmitter coil, power and battery pack, handheld alarm monitor, and sophisticated computer console.
"This is a momentous day for Abiomed and advanced heart failure patients who cannot recover their natural heart or receive a transplant. We have selected leading U.S. hospitals committed to the AbioCor program and expect patient implants with AbioCor to commence in early 2008," said Michael R. Minogue, Chairman, CEO and President of Abiomed.
Abiomed has selected four sites to date as AbioCor Centers including: The Johns Hopkins Hospital in Baltimore, MD; Robert Wood Johnson University Hospital in New Brunswick, NJ; Texas Heart Institute at St Luke's Episcopal Hospital in Houston, TX; and St. Vincent's Hospital in Indianapolis, IN.
HDE approval allows the AbioCor to be made available to a limited patient population, with no more than 4,000 patients receiving the technology in the United States each year. Abiomed expects to charge $250,000 per AbioCor unit in a controlled roll-out at up to five U.S. centers.
Abiomed News Release (01/22/08)
Trading Markets (01/22/08)
Medical News Today (01/24/08)
Medical Design Online (01/29/08)