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ACC In Brief

This article was originally published in The Gray Sheet

Executive Summary

Thoratec's HeartMate II: Thoratec expects FDA to approve its continuous-flow left-ventricular assist device as a "bridge to transplant" in heart failure patients this summer. Results of a 133-patient pivotal trial, submitted to FDA in December, were announced at the American College of Cardiology Scientific Sessions in New Orleans March 24-27 by Leslie Miller, M.D., Georgetown University. In the trial, 75% of patients met the primary endpoint of remaining eligible for transplant for at least 180 days or completing a cardiac transplant. Compared to adverse event rates observed in the clinical trials of Thoratec's first-generation HeartMate VE, the rate of percutaneous lead infections declines 90%, stroke is down 50%, and bleeding requiring surgery is down 40%. "The safety profile is really the most important [finding]," Jeff Nelson, president of Thoratec's cardiovascular division, told "The Gray Sheet." Thoratec expects to finish a trial to support a "destination therapy" indication for HeartMate II by the middle of this year (1"The Gray Sheet" Jan. 1, 2007, In Brief)...

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Thoratec Pushes Back Approval Timeline For HeartMate II After FDA Meeting

Thoratec has pushed back the expected approval timeframe for its HeartMate II continuous flow left ventricular assist device following a "100-day" meeting with FDA on May 1

Thoratec Pushes Back Approval Timeline For HeartMate II After FDA Meeting

Thoratec has pushed back the expected approval timeframe for its HeartMate II continuous flow left ventricular assist device following a "100-day" meeting with FDA on May 1

People In Brief

Northstar names CEO: Chief Operating Officer John Bowers assumes the top spot at Northstar Neuroscience June 29. Prior to joining Northstar in 2004, Bowers served 10 years at Guidant in marketing, business development and sales management, for a time leading the marketing and business development efforts for the company's drug-eluting stent business now owned by Abbott. He replaces Alan Levy, who will become chairman of the board. The firm is on track to submit a PMA by early next year for its cortical stimulation device for hand and arm rehabilitation in stroke victims. Clinical trials are ongoing for the device's use in treating stroke-related aphasia, tinnitus and treatment-resistant depression (1"The Gray Sheet" Oct. 9, 2006, In Brief). On April 26, Northstar reported a net loss of $4.3 million for the first quarter of 2007...

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