Fewer than 4,000 people per year are eligible for treatment with the Wingspan stent system, which has been used for an extremely small patient population, according to the company. In each year since the HDE was approved in August 2005, an average of fewer than 2,000 patients have received a Wingspan stent, according to Stryker.
At the meeting, the lead investigator of SAMMPRIS, Dr. Marc Chimowitz, medical professor of neurosciences at the Medical University of South Carolina, Charleston, said based on the data available in April 2011, one has to conclude that medical treatment is superior, but added that the final answer is not available, because longer-term data will be reviewed next year. (Dr. Chimowitz presented the results of SAMMPRIS at the meeting; he was not there on behalf of Stryker.)
The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, and at this meeting, three panelists were given waivers because their places of employment were SAMMPRIS study sites.