u seller being touched at 75c
Abiomed looks to sell hearts By Jennifer Heldt Powell Thursday, September 9, 2004
The Danvers company that has put mechanical hearts into 14 patients has asked regulators to clear the device for sale.
Abiomed Inc. wants the U.S. Food and Drug Administration to approve the AbioCor Implantable Replaceable Heart under the humanitarian device exemption, which will restrict sales but allow the product to get to market sooner.
They cost about $250,000. Experts say the devices will be covered by insurance.
``We have shown that we can extend life and we can extend life with quality,'' said Michael R. Minogue, Abiomed chief.
Some patients in the final clinical test of the heart survived weeks while others gained months.
The plastic-and-titanium device is fully implanted in the body and runs with the help of a portable external battery.
The 13th recipient, who received a new heart about 120 days ago in Louisville, Ky., celebrated his 35th wedding anniversary, entertained family and friends for his birthday party at the hospital and received visits from his dog. He is now beginning to make some trips out of the hospital.
The 14th patient, with about 100 days on the heart, is also recovering, but is undergoing kidney dialysis and other treatments because of complications from before he received the heart.
The company has withheld the patients' names to protect their privacy.
Abiomed expects to enroll a 15th patient in the trial as originally planned, although that isn't required for the application.
The company hopes to win approval by the end of March. Officials are confident because they have worked closely with the agency throughout the process, Minogue said.
In addition to the results of the clinical trial, federal regulators will be looking at the mechanical ability of the heart. So far, units in the laboratory have been running more than four years.
Under the humanitarian exemption, Abiomed will be allowed to sell only 4,000 hearts in the United States annually. But that is in line with the company's plan to have a controlled rollout, Minogue said.
Each year about 16,000 patients are in need of heart transplants, but only 2,000 get them.
Abiomed's heart will be available only to a limited number of patients - those who have failure on both sides of their heart and less than two weeks to live.
Abiomed is also developing the next generation of the device, which is smaller and uses different mechanics.
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