Abiomed Delays Implanting Device
BOSTON (AP) _ The maker of the world’s first self-contained artificial heart said Wednesday it is holding off implanting the device in nine more people while it studies the lessons learned from the first six patients.
Four of those patients have died, one of them during the implantation procedure.
Abiomed Inc. had planned to implant the experimental plastic-and-titanium heart in a total of 15 patients by the end of the June.
The company previously delayed trials of the device to determine the cause of strokes suffered by three patients, one of whom died. But spokesman Edward Berger said that Abiomed had fixed the piece suspected of playing a role in the strokes, and that was not the cause of the latest delay.
He said only that the Abiomed will spend the time ``focusing on integrating what we have been learning from the first five patients in order to maximize the clinical success with the next group of patients.″
Berger said Abiomed still expects to seek Food and Drug Administration approval by the end of next year.
Only patients with end-stage heart failure who have more than a 70 percent chance of dying within a month are eligible to receive the experimental device.
Chief financial officer John F. Thero said that ``given the extraordinarily fragile and compromised condition of the patients enrolled so far in this initial clinical trial, the clinical results have exceeded our expectations.″
Berger said no new timetable for implanting the device in more patients has been set.
``We are fully capable in the physical sense and the regulatory sense of doing an implant at any time and expect to resume implants quite soon,″ he said.
``But we’ve just been focussing on making sure that we have all of our ducks in a row so we’re fully integrated in what we’re learning so the next patients will do better than the last one.″
On the Net:
Abiomed Inc.: http://www.abiomed.com