The FDA is requiring Atritech to perform another study to confirm the safety and efficacy of the Watchman left atrial appendage closure device before it can receive full approval. Atritech said it will work closely with the FDA on the study design and that it hopes to start the study later this year.
The device was widely introduced to the cardiology community a year ago at the ACC with the presentation of the PROTECT AF trial. Despite a positive reception at the ACC, the Watchman received somewhat more critical reviews from the FDA staff, though it eventually received a positive, though hardly unanimous, vote of approval from the FDA’s Circulatory System Devices Panel. Publication of the trial in the Lancet was accompanied by a critical comment.
Here is the Atritech press release:
Atritech Announces FDA Regulatory Update
Confirmatory study required for final FDA approval, Latest data presented at the 59th annual ACC meeting in Atlanta earlier this week.
MINNEAPOLIS, March 18 /PRNewswire/ — 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.
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 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.
The PROTECT AF clinical trial evaluated the WATCHMAN® LAA Closure Device versus the current standard of care, Warfarin, in patients with non-valvular atrial fibrillation. February 2010 marked the 5-year anniversary of the first enrollment in the PROTECT AF trial. The trial enrolled a total of 800 patients and now has an average follow up of two years. PROTECT AF is the only prospective, randomized clinical trial comparing an LAA closure device to long term Warfarin therapy. In August 2008, the company began enrolling patients in a Continued Access Study in the U.S. and now has over 420 patients implanted.
“The adoption of the WATCHMAN technology in markets outside of the US has been largely due to the compelling data contained in the PROTECT AF clinical trial. The initiation of a confirmatory study combined with the continued follow up of our study patients will further establish the clinical significance of this important technology,” said Jim Bullock, President and CEO of Atritech.
Atritech is a privately held company based in Plymouth, Minnesota. Major investors in Atritech include Split Rock Partners, Thomas, McNerney and Partners, Prism Venture Partners, Tullis Health Investment Funds, The Vector Group, Thoma Cressey Funds, The Rahn Group, SightLine Partners and Affinity Capital. For more information, visit http://www.atritech.net.
SOURCE Atritech, Inc.