03/08/2016
5MAX ACE Available
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The Newest Clot Extraction Device to Treat Acute Ischemic Stroke Patients
Officials from Penumbra Inc. announced the launch and wide availability of the 5MAX ACE, a next generation clot extraction device that uses aspiration alone to engage and remove blood clots causing an acute ischemic stroke.
The 5MAX ACE makes use of more than six years of experience in advanced, large lumen medical device design to accomplish both exceptionally easy delivery and the highest aspiration flow rate of any such device on the market.
“The enthusiasm I hear from colleagues treating stroke patients is at an all-time high,” says J Mocco, MD, MS, associate professor of neurological surgery, Vanderbilt University Medical Center in Nashville, Tennessee and Principle Investigator for the prospective, randomized THERAPY Trial. “This enthusiasm is well deserved. We have seen brisk enrollment in THERAPY, a study designed to definitively establish whether modern stroke intervention is beneficial…physicians are eager to engage and understand the best treatments for their patients. We have recently seen private insurance company reimbursement decisions that are in line with current evidence-based medicine, and support the continued offering of endovascular stroke treatment to patients. Furthermore, the newest technologies have dramatically increased the rapidity and completeness of thrombus removal. Simply said, at all levels today: advanced trials, reimbursement, and device innovation, there’s reason for great optimism in acute stroke interventional treatment,” Dr. Mocco concludes.
“We can see the widespread enthusiasm that Dr. Mocco refers to when we look at our stroke business here at Penumbra,” states Adam Elsesser, CEO. “This enthusiasm has led to a dramatic increase in our stroke cases over the last several months. The initial feedback on our new 5MAX ACE device is so encouraging that we feel it’s well-poised to take advantage of this new excitement in the field.”
About Adapt
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ADAPT is the newest technique in treating Acute Ischemic Stroke caused by the blockage of blood flow to an area of the brain. Published in April 2013 in the Journal of NeuroInterventional Surgery (JNIS) by a consortium of Stroke Centers from around the US, the technique involves placing a 5MAX or 5MAX ACE aspiration device at the face of the clot and aspirating until the device becomes occlusive. The device is then gently withdrawn under continuous aspiration until the intact thrombus is removed.
About Therapy
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The THERAPY Trial is a landmark randomized-control trial designed to demonstrate the effectiveness of aspiration thrombectomy for stroke patients with large vessel occlusions. THERAPY employs a novel, state-of-the-art imaging-based patient selection algorithm that has the potential to define a population of patients particularly resistant to intravenous clot-busting drug, but particularly responsive to aspiration-based clot removal. This unique trial design, combined with the latest innovations in thrombectomy tools, may provide high quality evidence of the benefit of inside-the-artery clot removal treatment for patients suffering an acute stroke. THERAPY will enroll up to 692 patients at up to 75 sites around the world. www.ClinicalTrials.gov Identifier: NCT01429350
