October 13, 2014 — The use of brain stents may actually increase the risk of stroke compared to patients who receive drug-therapy alone, according to a study from researchers in Germany.
Brain stents are tube-like implants that are designed to widen arteries in the brain, which is supposed to reduce the risk of stroke. However, in recent years, a growing amount of evidence has shown that the stents may actually increase the risk of stroke for all but a small minority of patients.
The researchers found that, after dilation of blood vessels in the brain, patients who were implanted with a stent had a slightly higher risk of stroke compared to patients who only received blood-thinning medications.
The largest and most relevant clinical study, the SAMMPRIS trial, involved 451 patients. Of these, 59 patients (26.3%) who were implanted with a stent had a stroke, compared to 42 patients (18.5%) who were only given medications. Researchers concluded that mechanical manipulation during placement of the stent was probably to blame for the increased risk.
Soon after this study was published, the FDA restricted the approval of brain stents to patients who met a strict criteria, including at least 70% stenosis due to atherosclerosis of the intracranial artery.
The findings primarily impact Stryker’s Wingspan brain stent, which was originally approved in 2005 with a “Humanitarian Use” exemption. This loophole allows for fast-track approval of new devices that are intended to treat fewer than 4,000 people per year. Manufacturers only need to prove that the implant does not pose unreasonable safety risks to a patient.
Do I have a Wingspan Brain Stent Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting Wingspan brain stent induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a stroke, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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