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First Implantable artificial heart gets FDA’s approva

The first completely implantable artificial heart was approved by the U.S. Food and Drug Administration (FDA) on Tuesday.// The artificial heart has been approved for patients with severe heart problem, who are too ill for a heart transplant.

Under the FDA's Humanitarian Use Device provisions, the device, the AbioCor Implantable Replacement Heart, was approved. However, it restricts the use of more than 4,000 units of any device per year. The usage of this artificial heart is restricted to people with acute heart failure who cannot accept a heart transplant and are not likely to live for more than a month.

“We're talking about a small group of end-stage patients, whose choice is between immediate death or new, innovative technology,” said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.

Abiomed Inc. of Danvers, Mass. produced this replacement heart.
"This is an important step in this type of technology. We hope this approval will encourage the continued refinement and improvement of this technology," he said.
The clinical trial was conducted on 14 men who finally died.

"The device extended survival for an average of 4.5 months, allowing the patients to spend valuable time with family and friends," said Dr. Bram Zuckerman, director of the FDA's Division of Cardiovascular Devices. "In two cases, lives were extended by 10 and 17 months, respectively. One patient was discharged from the hospital."

The patient’s own heart is replaced by this device, which is a 2-pound mechanical heart. A power transfer coil charges the system across the skin and recharges the internal battery. A controller and an internal battery are implanted in the patient’s abdomen.

The functions of the controller are to monitor and control the device and also its pumping rate. The patient can be free from external connections for up to an hour because of the internal battery. There ar
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