Penumbra, Inc. Launches 5MAX™ ACE – The Newest Clot Extraction Device To Treat Acute Ischemic Stroke Patients
Third Generation Procedure Makes Treating Acute Stroke Patients Easier and Lowers Costs
Alameda, CA – July 8, 2013 – Today, 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.
“I’ve used every generation of device for clot removal since the early days, including most recently, the stent retriever devices,” said Blaise Baxter, MD, FRCPC, Director of Interventional Services at Erlanger Hospital in Chattanooga, Tennessee. “I can say with certainty after using the 5MAX ACE that this device is clearly superior to all the others. I am now able to get to the clot more quickly, and remove it more completely than ever before. The results are really just stunning.”
The 5MAX ACE makes use of more than 6 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 5MAX ACE has made it not only possible, but also cheaper, faster, safer, simpler and easier to utilize a pure aspiration approach as the primary tool for revascularization,” said Quill Turk, DO, Professor of Radiology, Director of Neurointerventional Division, Medical University of South Carolina in Charleston, South Carolina. “The increased size of the device’s inner lumen and end-hole diameter, make it possible to simply engage the clot, and if that doesn’t aspirate it completely, then to remove the remaining clot in one piece by simply withdrawing the device under continuous suction,” Dr. Turk explained. “This new Direct Aspiration First Pass Technique (‘ADAPT’) is optimized with the 5MAX ACE, and is showing superior clinical and angiographic outcomes as a first line approach with results far better than that of earlier generation devices,” concluded Dr. Turk.
“Having used the 5MAX ACE early on, I’m convinced that it represents the best of its kind. In my opinion this new method will be a significant game changer for interventional stroke treatment,” said Jeffrey Farkas, MD, Director of Interventional Neuroradiology at Lutheran Medical Center in Brooklyn, New York. “In each of our first three cases with 5MAX ACE, we literally had the clot completely removed in 1 minute of aspiration and the patients made astounding recoveries. This is really a revolution in our extensive experience with acute stroke devices.”
“At our center, we now see complete thrombus removal without distal embolization—which is the highest level on the reperfusion scale—in a significant majority of our cases using 5MAX ACE and the ADAPT technique. This is an immediate clinical outcome that we’ve never seen before. On top of that, we’re able to get these results in 1 to 3 minutes,” said Don Frei, MD, Director of Neurointerventional Surgery, Radiology Imaging Associates/Swedish Medical Center in Denver, Colorado. “The results we are getting from the 5MAX ACE help maintain the high degree of confidence our referral centers have in us to take care of their patients. I think that’s one factor in the growth we continue to see in our acute stroke business,” Dr. Frei added.
“The enthusiasm I hear from colleagues treating stroke patients is at an all-time high,” said 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 concluded.
“We can see the widespread enthusiasm that Dr. Mocco refers to when we look at our stroke business here at Penumbra,” said 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.”
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.
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
ABOUT Penumbra, Inc.
Penumbra, Inc. is a global interventional therapies company committed to delivering clinically beneficial products that help patients suffering from stroke and other vascular diseases. Penumbra’s global headquarters is located in Alameda, California with sales operations in North and South America, Europe, Australia and Asia.
Penumbra Media Relations:
Rachael Kopeck, 510-748-3200
1Turk AS, Spiotta A, Frei D, et al. J NeuroIntervent Surg. Published Online First: April 27, 2013. doi:10.1136/neurintsurg-2013-010713