October 13, 2014 — The safety risks of brain stents have been highlighted in a study confirming an increased risk of stroke compared to patients who received drug treatment alone.
The study found that the risk of stroke was higher in patients who, after dilation of blood vessels in the brain, were implanted with a stent and given clot-inhibiting medications. The researchers also found no evidence of a benefit from stenting.
These findings were based on data from four randomized clinical trials, including three that compared stenting with drug treatment alone. The largest and most relevant study was the SAMMPRIS clinical trial, which included 451 patients.
During this study, strokes occurred in 59 patients (26.3%) who were implanted with a stent, compared to 42 patients (18.5%) who were not. In many cases these strokes were apparently caused by mechanical manipulation during placement of the stent.
This study confirms findings that led the FDA to limit approval of brain stents in 2012. The FDA was also concerned about higher rates of stroke in the SAMMPRIS clinical trial.
Stryker’s Wingspan Brain Stents was originally approved in 2005 with a “Humanitarian Use” exemption, which fast-tracks approval for devices that are intended to treat fewer than 4,000 individuals per year. This process allows approval of devices that have not been proven effective for its intended purpose, so long as it does not pose unreasonable safety risks to a patient.
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