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Bear Stearns Healthcare Conference In Brief

This article was originally published in The Gray Sheet

Executive Summary

HeartMate II trial: Thoratec will submit a protocol to FDA for its second-generation destination therapy left-ventricular assist device clinical trial "fairly soon," President & CEO Keith Grossman told Bear Stearns Healthcare Conference attendees in New York Sept. 14. The study likely will include two arms: a 50-100 patient, non-randomized, non-controlled bridge-to-transplant arm and a 150-200 patient destination therapy arm with two-year follow-up, randomizing HeartMate II to HeartMate. The trial will support a PMA filing for the bridge indication and subsequent PMA supplement for destination therapy (1"The Gray Sheet" Dec. 8, 2003, p. 26)....LVAD reimbursement: The number of centers qualified by CMS to receive reimbursement for destination therapy should increase from 68 to about 100 in the next few years, Thoratec's Grossman predicts. CMS is creating a "more formal certification program that probably within the next six to 12 months will be in place" and should allow centers to get certified in a more fluid way...
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