Penumbra launches 5Max-Ace to treat acute ischaemic stroke

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On 8 July, Penumbra 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 that cause an acute ischaemic stroke.

“I have used every generation of device for clot removal since the early days, including most recently, the stent retriever devices,” said Blaise Baxter, director of Interventional Services, Erlanger Hospital, USA. “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 has made it not only possible, but also cheaper, faster, safer, simpler and easier to utilise a pure aspiration approach as the primary tool for revascularisation,” said Quill Turk, professor of Radiology, Director of Neurointerventional Division, Medical University of South Carolina in Charleston, USA. “The increased size of the device’s inner lumen and end-hole diameter, make it possible to simply engage the clot, and if that does not aspirate it completely, then to remove the remaining clot in one piece by simply withdrawing the device under continuous suction,” Turk explained. “This new Direct Aspiration First Pass Technique (‘ADAPT’) is optimised 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 Turk.

“Having used the 5Max Ace early on, I am 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, director of Interventional Neuroradiology, Lutheran Medical Center in Brooklyn, USA. “In each of our first three cases with 5Max Ace, we literally had the clot completely removed in one minute of aspiration and the patients made astounding recoveries. This is really a revolution in our extensive experience with acute stroke devices.”

“At our centre, 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 have never seen before. On top of that, we are able to get these results in one to three minutes,” said Don Frei, director of Neurointerventional Surgery, Radiology Imaging Associates/Swedish Medical Center in Denver, USA.

“The enthusiasm I hear from colleagues treating stroke patients is at an all-time high,” said J Mocco, associate professor of Neurological Surgery, Vanderbilt University Medical Center, Nashville, USA, and principal investigator for the prospective, randomised 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 is reason for great optimism in acute stroke interventional treatment,” Mocco concluded.