FDA approves implantable artificial heart
06 September 2006
The US Food and Drug Administration (USFDA) has approved the first fully implantable artificial heart - the AbioCor Implantable Replacement Heart - made by the Danvers-based company Abiomed Inc.
The whirring 2-pound pump made of plastic and titanium, is the result of three decades of research and three years of human trial.
One of the most complex and expensive devices in medical history, the $250,000 device may not help keep patients alive indefinitely, but rather extend the lives of dying people too sick to receive a transplant.
The device would help patients whose hearts are so weak that they can no longer keep blood flowing to vital organs.
The artificial heart will be allowed to be sold for "humanitarian use", an exemption for products that help some patients with no alternatives.
FDA has set a sale limit of around 4,000 units for Abiomed's artificial heart. The company must also closely monitor patients who receive the devices.