December 20, 2011

Dear Dr. Wolfe

I write this note in support of your petition to the FDA to withdraw the HDE approval from the Wingspan  stent and to request a recall of this device.

When the Wingspan stent was first approved using the HDE mechanism in 2005, there was limited data  on safety and effectiveness. In the interim, more data have been collected, and the FDA should now be  in a better position to evaluate its risks and benefits. With the conclusion of the recent SAMMPRIS trial  showing that Wingspan has a much higher complication rate than modern medical management, it is  imperative that the FDA take swift and decisive action. I have looked at the FDA website and tried to  find out whether the Agency has even warned clinicians using a Medical Device Safety  Communication. I cannot locate such a notice and would ask the FDA to explain why they have been so  silent in the face of this significant trial showing clear concerns about this regulated medical device.   I  can see no reason why this device should continue to be available.  I agree with your petition to the FDA  to immediately withdraw the HDE approval for this device.

As you know, I spent over 6 years as Director of the Office of Surveillance and Biometrics and over 6  years as Director of the Office of Science and Engineering Laboratories at CDRH/FDA. I understand that  the FDA needs to use its regulatory authority in flexible and not dogmatic ways and granting of HDEs  when data about safety and effectiveness are not complete is a legitimate exercise of regulatory  authority. However, for that flexibility, the FDA must realize it has an equally important duty to move  swiftly to make regulatory changes and announcements when device problems are uncovered.

These compelling postmarket data about the Wingspan stent provide an opportunity for the FDA to  show to industry, the clinical community, and most of all to patients that the Agency is serious about  exercising its authority by withdrawing the HDE immediately and insisting on a recall to ensure the  devices on the US market are both safe and effective.  

Sincerely,

Larry Kessler, Sc.D.
Professor and Chair
Department of Health Services
School of Public Health
University of Washington
H664 Health Sciences Center
1959 NE Pacific Street
Box 357660
Seattle, WA 98195
Phone: 206-543-2703
Fax: 206-543-3964
email: kesslerl@uw.edu