Medtronic’s Solitaire stent retriever has notched another indication, this time for the reduction of stroke-related disability in some patients suffering from acute ischemic stroke.
Originally cleared in March 2012, the device is designed to restore blood flow in patients experiencing acute ischemic stroke by removing a clot from blood vessels in the brain. The new indication allows the company to market the device as an initial therapy to ward off disability brought on by acute ischemic stroke in patients with persistent, proximal anterior circulation, large vessel occlusion and smaller core infarcts, Medtronic said in a statement.
Acute ischemic stroke may result in paralysis and speech difficulties, among other disabilities. The Solitaire stent retriever should be used after patients have received the clot-dissolving drug IV-tPA and within six hours of symptoms appearing, according to the statement.
"Stroke is the fifth leading cause of death in the U.S. and the number one cause of severe disability," said Dr. Jeffrey Saver, a professor of neurology at UCLA’s Geffen School of Medicine and director of the UCLA Comprehensive Stroke Center, in the statement. "The availability and access to a technology that reduces stroke disability is critically important because with such innovations, stroke patients and their families may experience less physical, emotional and financial burdens from their condition."
This expanded approval is backed by data showing that treating patients with the Solitaire device in addition to administering IV-tPA “significantly” reduced disability following a stroke, according to the statement. The combined treatments also boosted the number of patients who were functionally independent within 90 days post-stroke.
Meanwhile, the FDA cleared two Stryker clot retrieval devices as a first-line therapy for ischemic strokes to be used alongside tPA with hopes of reducing stroke-related disabilities. The devices were first cleared in 2012 to retrieve blood clots in patients who were ineligible to receive tPA, or for whom the drug did not work.