June 5, 2015 - Penumbra Inc. announced that the company's ACE64 aspiration thrombectomy system received 510(k) marketing clearance from the U.S. Food and Drug Administration for the revascularization of large vessel occlusions in patients with acute ischemic stroke.
The efficacy and safety of mechanical thrombectomy has been demonstrated in the MR CLEAN trial and confirmed in additional randomized controlled stroke trials. ACE64 enables physicians to bring powerful clot extraction capability directly to the occlusion and remove the clot en masse. Early experience from multicenter study in Europe, where ACE64 is already available, reported high rates of revascularization at 96 percent TICI 2b/3, a fast procedure time of 37 minutes on average and mRS scores ≤2 at discharge of 48 percent.
"ACE64 is the latest technology improvement in mechanical thrombectomy," said Rob T. Lo, M.D., University Medical Center Utrecht, The Netherlands, a center in the MR CLEAN trial. "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."
Penumbra's aspiration thrombectomy devices use a minimally invasive "vacuum" inside the artery to remove a blood clot. The next-generation ACE64 features an even larger aspiration lumen compared with ACE to evacuate large clot burdens.
For more information: www.penumbrainc.com
November 12, 2025 
