|Cleveland Clinic Names Stent Retriever Technology One of the Top Medical Innovations for 2016|
Medtronic Pioneered the First Stent Retriever in 2007 with the Introduction of the SolitaireTM Stent Retriever Device
DUBLIN - October 28, 2015 - The Cleveland Clinic has named stent retriever technology, which includes Medtronic plc's (NYSE: MDT) SolitaireTM stent retriever device, to a list of the top medical innovations for 2016. The top medical innovations list was revealed today at the Cleveland Clinic's 2015 Medical Innovation Summit.
This news comes months after the American Heart Association/American Stroke Association (AHA/ASA) published new stroke treatment guidelines that recommend the use of stent retriever technology in conjunction with the current standard of care, IV-tPA, as a first-line treatment for eligible patients. The guidelines were 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, all of which studied the Solitaire device, 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.
"Since Medtronic's invention of the first stent retriever in 2007, our commitment to fighting stroke and bringing medical innovations to patients continues to grow," said Brett Wall, president of the Neurovascular business, which is part of the Restorative Therapies Group at Medtronic. "The five landmark global clinical trials have proven the Solitaire device as a major advancement in the treatment of stroke, reducing functional disability in patients. Having this technology recognized by the Cleveland Clinic's prestigious medical innovations list as well as the new AHA/ASA guidelines has further validated our belief in stent retrievers."
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.
"The Cleveland Clinic's recognition of stent retrievers as a top medical innovation further demonstrates that this technology is a game-changer in stroke care," 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. "Stroke remains the number five killer and the number one cause of severe disability in the U.S. and we must ensure patients have access to these new therapies that have ushered in a new era of stroke care."
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 Solitaire FR stent retriever device received U.S. Food and Drug Administration 510(k) clearance in 2012 and Solitaire FR received CE Mark approval in 2009.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.