There was an update today on the long-awaited FDA status of Atritech’s WATCHMAN® device. If approved, it would provide an alternative to taking Coumadin or warfarin to prevent strokes for those with atrial fibrillation.
Here are some quotes from the press release.
Minneapolis (March 18, 2010) — Atritech, Inc., an emerging medical device company, announced today that it has obtained clarity from the U.S. Food and Drug Agency (FDA) on the regulatory path towards full approval of its WATCHMAN® Left Atrial Appendage (LAA) Closure Technology in the United States.
In a recent letter received from the FDA, the agency requested that a confirmatory study be conducted to further substantiate the safety and effectiveness of the WATCHMAN® LAA Closure Technology in patients with atrial fibrillation at risk of stroke and eligible for anticoagulation therapy. Atritech will be working closely with the FDA to finalize the study design and is looking to start the confirmatory study later this year.
Also mentioned in the press release was the presentation this week at the American College of Cardiology meetings of data related to the WATCHMAN®.
Earlier this week, American College of Cardiology’s (ACC) President-Elect Dr. David Holmes, presented 1350 patient years of follow up data from the PROTECT AF clinical trial at the annual ACC meeting in Atlanta. Highlights of the data include a 31% risk reduction in all stroke, cardiovascular death and systemic thromboembolism [blood clots] in the WATCHMAN group as compared to patients on Warfarin. The results presented were comparable to those presented in the initial data published in The Lancet, August 2009.
It’s good to find out where this stands with the FDA as it has been nearly 11 months since the FDA Advisory Committee voted 7-5 in favor of recommending approval. The small study size and safety concerns were at issue, and this announcement clarifies what is still needed for FDA approval.
For more information and background about the FDA’s review of the WATCHMAN device, read: Watchman Device as Alternative to Warfarin or Coumadin – Updated 4/24/09