DUBLIN - June 29, 2015 - Today, the American Heart Association/American Stroke Association (AHA/ASA) published new stroke treatment guidelines that recommend the use of stent retriever technology - such as Medtronic plc's (NYSE: MDT) SolitaireTM stent retriever device - in conjunction with the current standard of care, IV-tPA, as a first-line treatment for eligible patients.
The guidelines are based on a panel of experts' analysis of the results from five global clinical trials published in The New England Journal of Medicine (NEJM) that found the addition of stent retriever technology, a surgical procedure that manually removes blood clots from the brain, to current medical therapy such as IV-tPA, has a therapeutic benefit over medical therapy alone. These trials showed that the addition of stent retriever technology reduced disability, improved neurological outcomes and increased the rate of return to functional independence in patients suffering stroke.
"This is a tremendous leap forward in establishing the best possible protocol for the treatment of stroke, the number five killer and the number one cause of disability in the U.S.," said Elad Levy, MD, MBA, FACS, FAHA, chairman of neurological surgery and professor of neurosurgery and radiology at State University of New York at Buffalo. "The panel believes strongly that these changes will provide great benefit to patients and our broader society as we continue to elevate the level of care needed to significantly reduce the impact of this devastating disease."
The primary stent retriever studied in the global trials was the Solitaire device. Three of the five trials - SOLITAIRE(TM) FR With the Intention For Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME), Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours (REVASCAT) and EXtending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial (EXTEND-IA) - studied the Solitaire stent retriever exclusively, making it the only stent retriever that was used in every one of the five NEJM-published randomized trials.
The Solitaire stent retriever uses a micro-sized catheter to access arteries in the brain affected by stroke through an incision in the leg. Once delivered, the device helps to immediately restore blood flow and remove the blood clots causing the stroke.
"Since Medtronic's invention of the first stent retriever in 2007, our commitment to fighting stroke has not wavered," said Brett Wall, president of the Neurovascular business, which is part of the Restorative Therapies Group at Medtronic. "We helped to bring the five global trials to bear that have proven this device can be a gamechanger in the treatment of stroke, reducing functional disability in patients. The AHA/ASA guidelines have validated our commitment to and belief in this technology, and we will work hard to make it accessible to as many stroke patients as possible."
Of the 695,000 acute ischemic stroke victims in the U.S., about 240,000 are eligible for treatment with stent retrievers. However, while these devices are available at more than 500 hospitals in the U.S., only about 13,000 procedures are performed annually.
"The new national guidelines recognize stent retrievers as a major advance in stroke care, and indicate that we should strive to deliver catheter-based reperfusion to patients widely and rapidly," said Jeffrey L. Saver, MD, FAHA, FAAN, FANA, professor of Neurology, Geffen School of Medicine at the University of California, Los Angeles (UCLA) and director, UCLA Comprehensive Stroke Center. "And since time lost is brain lost in acute stroke, patients with emergency large vessel occlusions should be transported as rapidly as possible to a center capable of providing this treatment option expertly and efficiently."
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