FDA Approves Implantable Artificial Heart

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Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 06 Sep 2006 - 10:00 PDT


An artificial heart that can give dying heart failure patients a few extra months of life has been approved by the US Food and Drug Administration (FDA). The device is the size of a grapefruit and is made of titanium and plastic. Its makers, Abiomed Inc. named it 'AbioCor'.

The device will be used for patients with severe heart failure - heart failure on both sides of the heart (bi-ventricular) - who cannot have a heart transplant and are not expected to survive more than one month. Clinical trials showed a patient's life can be extended by four and a half months, giving more time to spend with family and friends. It is the first completely self-contained artificial heart - there are no wires or tubes piercing through the skin.

AbioCor, which costs $250,000, replaces the patient's heart (which is removed). The device has a power transfer coil which recharges the internal battery. A controller, and internal battery are placed in the abdomen.

The FDA approved the artificial heart under its Humanitarian Use Device Exemtion (HDE). Up to 4,000 units can be used each year. HDE approval is for patients facing death and no comparable alternative therapy. To receive HDE approval a device must be proven to be safe and have probable benefit for patients.

In the USA 57,000 people died from chronic heart failure in 2006, of which 2,200 received transplanted donor hearts.

Michael R. Minogue, Chairman, CEO and President of Abiomed Inc., said "FDA approval of the AbioCor provides new hope for heart failure patients who cannot recover their natural heart or receive a transplant. Abiomed has been a leader in recovering patients' hearts following an acute event and with this approval, we have expanded our product portfolio to treat patients with chronic heart failure as well. We are pleased with this landmark decision and extremely proud of the extensive efforts of our employees, scientists, numerous healthcare professionals, FDA staff and individuals and families who have been actively involved in the clinical study of the AbioCor to advance the future of medical technology."

http://www.abiomed.com.
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