KALAMAZOO, Mich., June 29, 2015 /PRNewswire/ -- New guidelines released today by the American Heart Association and American Stroke Association give hope for better outcomes to the hundreds of thousands of patients who experience an acute ischemic stroke each year. Stryker's Trevo® Retriever was one of the key products used in the clinical trials that provided data for this development.
The new AHA/ASA guidelines strongly recommend endovascular therapy with stent retrievers for ischemic stroke patients who meet certain treatment criteria. One such criterion is that endovascular treatment be administered within six hours of symptom onset. This treatment time window is vital to providing stroke patients with the best chance for good outcomes.1
Five recent clinical trials provided pivotal evidence justifying changes to the current AHA/ASA recommendations guiding the way physicians treat patients suffering from an acute ischemic stroke in which one of the large vessels in the brain is occluded.
The first and largest of these trials leading to new guideline recommendations was the MR CLEAN trial (Multicenter Randomized Clinical trial of Endovascular treatment for acute ischemic stroke in the Netherlands). In this 500 patient study, investigators found that using intra-arterial treatment to remove a stroke-causing blood clot in a large vessel supplying blood to the brain provides better outcomes than trying to dissolve the clot using a clot-busting drug (lytic) alone, which was the previous standard of care. Stryker's Trevo Retrievers were used to treat 66% of the patients receiving intra-arterial treatment in this trial, making it the most used device in this study.2
MR CLEAN, along with four other studies from Canada, the United States, Europe and Australia, account for a significant amount of high-quality evidence demonstrating improved outcomes for patients receiving endovascular therapy with stent retrievers in addition to clot-busting drugs (lytics).
"This is a watershed moment in the treatment of stroke patients, not just in the United States but in much of the world," says Donald V. Heck MD, Director of Interventional Neuroradiology and co-Director of the Novant Health Forsyth Comprehensive Stroke Center in Winston-Salem, NC. "The technology has progressed to the point that there is now overwhelming evidence that treatment of the largest, most devastating type of stroke requires emergent endovascular intervention in addition to thrombolysis. We now have the mandate to organize our communities, emergency medical services, and hospitals to quickly deliver this life-saving treatment to those patients suffering from large strokes. That is the next necessary step if we are to realize the promise of fewer lives lost, and fewer lives disabled."
"The Stryker Trevo® Retriever was used to successfully treat the majority of patients in the first and largest of the recent stent retriever trials, which speaks to the product's ability to reliably remove clot during these difficult procedures in a wide range of patients," says Mark H. Paul, President of Stryker Neurovascular. "The Trevo ProVue Retriever also received the Prix Galien USA award for best medical technology in 2014. We are pleased to see the impact of our commitment to 'Complete Stroke Care®' and providing the best tools, services and training for physicians who treat stroke patients."
An animation and images of Stryker's Trevo XP ProVue Retriever are available here: www.trevoxp.com
For more information on how to detect a stroke and how to get help, please download our patient information booklet here: www.trevopatientinfo.com
- Powers, W., Derdeyn, C. et. Al. 2015 AHA/ASA Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment. Stroke.ahajournals.org/content/early/2015/06/26/STR. 0000000000000074. Accessed June 29, 2015.
- Data on file at Stryker Neurovascular.
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Douglas Petkus, Ketchum Inc.