Originally Published MX September/October 2005
COVER STORY
Cardiac-Assist Devices and FDA Efforts|
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Cardiac-assist devices—life-supporting products that incorporate a wide range of complex technologies—face a difficult regulatory environment. But according to D. Keith Grossman, CEO of Thoratec Corp. (Pleasanton, CA), the current clinical trials for his company's next-generation product are evidence of FDA's efforts to work with industry and clinicians in shortening the time-to-market for such products.
Thoratec's present version of its HeartMate left ventricular assist device (LVAD) is currently the only product to have FDA approval for destination therapy. Destination therapy refers to the device's use as a long-term permanent implant, designed for late-stage heart failure patients who do not qualify for transplants.
The new version of the device, HeartMate II, is currently being tested in pivotal clinical trials for both bridge-to-transplantation and destination-therapy indications. According to Thoratec, the current trials mark the first time that FDA has approved a clinical trial design that includes both indications in a single protocol.
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| The HeartMate II implantable LVAD. (click to enlarge) |
The HeartMate II is a 14-oz implantable LVAD consisting of a miniature axial-flow blood pump. It is intended for long-term support, and is designed to be smaller, simpler, quieter, and longer-lasting than current-generation devices.
The company anticipates FDA approval for the bridge-to-transplantation indication—designed for late-stage heart failure patients who are listed for cardiac transplants but are at imminent risk of dying—in 2007. It expects destination-therapy-indication approval in 2009.
In August, Thoratec announced that 100 patients have been implanted with the Heartmate II worldwide. The company anticipates European Union CE mark authorization for both the bridge-to-transplantation and destination-therapy applications to be issued by the end of this year. Such approval will allow the commercial launch of the device in Europe.
Looking further down the product pipeline, the HeartMate III is currently in animal trials and is likely going to clinical trials sometime in the next year and a half, according to Grossman. The HeartMate III is a fully implantable device, requiring no external connections.
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