Penumbra, an Alameda, California firm, obtained FDA 510(k) clearance to introduce its ACE64 aspiration thrombectomy device in the U.S. The device is indicated for clearing large vessel occlusions in patients suffering from acute ischemic stroke. The ACE64 is essentially a micro-vacuum that can be snaked through the vasculature to suck and remove the entire clot.
The ACE64 device is a larger version (0.064” distal inner diameter) of the company’s ACE system, having the ability to tackle clots that were previously too big for ACE to handle. This is now the largest lumen aspiration thrombectomy device on the market, and it’s been cleared for use in Europe late last year.
From the announcement:
Early experience from a European multicenter study, 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, MD, 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.”