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LVAD Makers Must Grow Patient Pool Or Some Competitors Will Wilt

This article was originally published in The Gray Sheet

Executive Summary

FDA is unmoved by developers' pleas to relax clinical data requirements for destination ventricular assist devices so more competitors can enter the VAD market

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Heartmate II trial

Thoratec expects to launch a Phase II pivotal trial for the second-generation, destination therapy left-ventricular assist device (LVAD) "in the next several weeks," CEO Keith Grossman says. Presenting at the JPMorgan Healthcare Conference Jan. 12, Grossman touted the rotary pump-driven device as being one-fifth the size and roughly one-third the weight of the HeartMate I. HeartMate III, featuring a pumping rotor that hovers inside a magnetic field to minimize wear, is slated for clinical study "in the next year or two," according to Grossman. The exec predicted that HeartMate I, currently the only FDA-approved destination therapy LVAD, will have sole possession of the market for "at least the next three to five years." MicroMed (DeBakey), WorldHeart (Novacor) and Arrow (LionHeart) currently are developing LVADs (1"The Gray Sheet" Oct. 18, 2004, p. 5)...

Heartmate II trial

Thoratec expects to launch a Phase II pivotal trial for the second-generation, destination therapy left-ventricular assist device (LVAD) "in the next several weeks," CEO Keith Grossman says. Presenting at the JPMorgan Healthcare Conference Jan. 12, Grossman touted the rotary pump-driven device as being one-fifth the size and roughly one-third the weight of the HeartMate I. HeartMate III, featuring a pumping rotor that hovers inside a magnetic field to minimize wear, is slated for clinical study "in the next year or two," according to Grossman. The exec predicted that HeartMate I, currently the only FDA-approved destination therapy LVAD, will have sole possession of the market for "at least the next three to five years." MicroMed (DeBakey), WorldHeart (Novacor) and Arrow (LionHeart) currently are developing LVADs (1"The Gray Sheet" Oct. 18, 2004, p. 5)...

Thoratec May Be Acquisition Target For Firm With Access To Cardiologists

Thoratec may seek to be acquired by a larger cardiac rhythm management or heart surgery concern to help bolster referrals for its HeartMate left-ventricular assist device (LVAD) destination therapy

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