FDA Limits Use of Stryker Brain Stent Due to Heightened Risk of Death or Stroke
August 9th, 2012 tmccoy
Yesterday, the FDA announced that it has just narrowed the approved usage of a Stryker SYK -0.02% brain stent that is used to help widen the arteries of patients who have had multiple strokes. This stent, also known as the “Wingspan Stent System” was approved by the FDA in 2005 to treat stroke victims who have had 50% or more narrowing of their brain arteries that have not responded to drug treatment. The buildup of plaque in these arteries leads to the narrowing, which can lead to strokes from the reduced blood flow to the brain.
The FDA has narrowed the use of the Wingspan Stent System. Now, doctors can only use this stent on people aged 22 to 80 who have arteries that are narrowed between 70% to 99%, have had 2 or more previous strokes, and have made a ‘good recovery’ from those strokes, and the most recent stroke must have occurred at least seven days prior to the placement of the stent.
In March, an FDA advisory panel said that even though the clinical data did not show that patients truly benefited from the device, a few members had the belief that the stent may be appropriate for a small segment of the patient population. The FDA declined to entirely remove the device from the market.
A study that was published in the New England Journal of Medicine last September stated that 14% of patients who had the Wingspan device placed along with drug treatment had another stroke or died, while only 5.8% of the drug only group died or had another stroke. All of the adverse events were within six days of the stent placement, most happening within a day. Within a year, 20% of patients with the stent and 12.2% of patients taking only drugs had died or suffered another stroke. The study was ended early after it was discovered that the stent created a heightened risk of death or stroke.
The FDA decided that there were differences in the patients who were in the group that was enrolled in the study which supported the 2005 approval of the medical device than in the recent study that was halted. The FDA found that a very specific subgroup could benefit because they have exhausted all other treatment options.
Source: Wall Street Journal
