Abbott’s Xact Carotid Stent To Join Guidant’s Acculink In U.S. Market
This article was originally published in The Gray Sheet
Executive Summary
Abbott plans to focus its initial marketing of the Xact carotid stent on physicians most experienced with the device, which Abbott will launch immediately
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ACC In Brief
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)...
ACC In Brief
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)...
Asymptomatic Carotid Stenting Demands Strict Safety Evidence – TCT Debate
The morbidity and mortality rate for carotid stenting in asymptomatic patients must drop below 1% before the procedure should become standard of care for that population, Christopher Zarins, MD, Stanford University argued Oct. 17 at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in Washington, D.C