Penumbra said today that it has received 510(k) clearance from the FDA for its Ace64 aspiration thrombectomy device, based on data from the Mr. Clean trial and additional randomized controlled stroke trials.
The Ace64 uses a minimally invasive "vacuum" inside arteries to remove blood clots, the Alameda, Calif.-based company said. The device is the largest-lumen aspiration thrombectomy device on the market, according to Penumbra.
The Ace64 is a larger version of its predecessor Ace device, which CEO Adam Elsesser told MassDevice.com can make a serious difference in removing clots.
"What may not seem like a lot makes a significant difference in the ability to directly aspirate clots in the brain," Elsesser told MassDevice.com in an interview. “In treating ischemic stroke, the challenge is always to get the complete clot out as fast as possible, because time matters and the completeness of the revascularization matters. Those are really the 2 factors that devices can control to some degree. We at Penumbra are very excited, because this seems to, in our early experience, improve the completeness of revascularization and lower the time of the procedure, which benefits patients.”
The Ace64 won CE Mark approval in the European Union in December 2014, with an indication for acute ischemic patients with large vessel occlusive disease within eight hours of symptom onset.
"Ace64 is the latest technology improvement in mechanical thrombectomy. I have used Merci and the different stent retrievers as well as the prior Ace aspiration thrombectomy system. With the new Ace64, I am achieving even higher revascularization rates, particularly TICI 3, while reducing procedure times and minimizing overall procedure costs. Ace64 is now my frontline tool for treating patients with acute ischemic stroke," Dr. Rob Lo of the University Medical Center in Utrecht, Holland, said in a press release.
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