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FDA approves first implantable artificial heart Print E-mail Disable live quotes RSS Digg it Del.icio.us By Val Brickates Kennedy, MarketWatch Last Update: 3:23 PM ET Sep 5, 2006
BOSTON (MarketWatch) -- The Food and Drug Administration has given the green light for the use of Abiomed's artificial heart device, called AbioCor, in terminally ill cardiac patients, the agency said Tuesday. According to the FDA, AbioCor is the first fully-implantable artificial heart for patients with advanced failure in both heart chambers. The device will be available only to patients who have about a month to live and are not eligible for a heart transplant. Danvers, Mass.-based Abiomed (ABMD : ABIOMED Inc News , chart, profile, more Last: 15.01+0.30+2.04% 3:25pm 09/05/2006 Delayed quote data Add to portfolio Analyst Create alert Insider Discuss Financials Sponsored by: 15.01, +0.30, +2.0% ) confirmed the approval, stating that it intends to roll out the product initially at five to ten heart centers around the U.S. The company added it is working with the government and private insurers to set reimbursement policies for the device. Chart of ABMD As opposed to earlier artificial heart devices, the AbioCor device is totally contained in the body. The heart is powered by external battery packs that can be recharged through a power outlet. In addition, the heart has an internal battery that allows the patient to be free from all external hook-ups for about an hour, during which time they could do such things as take a shower. Abiomed said last year that the initial cost of the AbioCor device could range between $200,000 and $250,000. The FDA made the approval under the Humanitarian Use Device provision of the Food, Drug and Cosmetic Act. The provision allows for the sale of up to 4,000 devices a year for patients who would otherwise have few or no treatment options. The provision also allows for devices to be marketed without large-scale human testing if such testing is considered to be impractical, and if the device will only be used on a limited number of patients. "This device represents a significant advance in artificial heart technology and holds promise for critically ill heart patients who are not candidates for heart transplants due to age or other medical conditions," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "We hope today's approval will encourage the continued development of potentially life-saving technologies for critically ill patients," Schultz added. The FDA noted that Abiomed will also conduct a 25-patient post-marketing study for AbioCor. The agency said the approval was made based in part on a small clinical study of 14 heart failure patients. In that study, the AbioCor device was able to extend the lives of some patients by several months, and one patient by 17 months. One patient responded well enough to be discharged from the hospital and return home. "FDA recognizes that not all patients who are eligible will choose this option, but for many patients faced with death, the chance to have additional time with family and friends-however limited-is a chance they are willing to take," said Schultz. End of Story
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