מתוך medicontext.co.il
WASHINGTON (Reuters Health) – Abiomed Inc. said on Monday that it has received permission from the US Food and Drug Administration (FDA) to implant its mechanical heart in five additional patients.
The Danvers, Massachusetts-based company said the FDA gave it the green light to proceed with its AbioCor Implantable Replacement Heart clinical trial, which calls for a total of fifteen implants to be done in groups of five.
So far, the company has implanted the device in five patients.
The first patient was Robert Tools, who suffered a serious stroke about 10 days ago. Tools received the implantable heart on July 2. The device meant he would be susceptible to blood clots–as with any artificial heart valve–but doctors were unable to deliver the necessary doses of anticoagulants because of Tools' tendency to bleed internally.
Abiomed said the overall success of its mechanical heart is being measured by the degree to which it can extend the lives and improve the quality of life of patients who otherwise have less than 30 days to live and have no other therapeutic option.
All five of the original patients are now in varying stages of rehabilitation and the AbioCor hearts have themselves functioned flawlessly, according to the firm.
"The first five AbioCor patients have demonstrated that we have made significant progress toward the ultimate goal of providing meaningful life extension to end-stage heart failure patients with no other alternative," said Abiomed CEO Dr. David M. Lederman in a statement. "But there is much left to prove and many lessons to be learned as we proceed. We look forward to these next implants with great hope and high expectations."
In Monday afternoon trading on the NASDAQ, shares of the company were up 0.80 at 20.13.
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