Penumbra's Ace64 Thrombectomy System Receives 510(k) Clearance for Acute Ischemic Stroke

May 27, 2015—Penumbra, Inc. announced that the Ace64 aspiration thrombectomy system has received 510(k) clearance from the United States Food and Drug Administration for the revascularization of large vessel occlusions in patients with acute ischemic stroke. The device enables interventionists to evacuate large clot burdens using a minimally invasive aspiration technique. Ace64, which received CE Mark clearance in December 2014, is intended for acute ischemic stroke patients with large vessel occlusive disease within 8 hours of symptom onset.

The safety and efficacy of mechanical thrombectomy for acute ischemic stroke was confirmed by the MR CLEAN trial. Since then, data from other studies, such as ESCAPE and EXTEND-IA, has supported the effectiveness of endovascular neurointerventional procedures.

Summarizing the early clinical experience from a European multicenter study, Penumbra cited high rates of revascularization at 96% TICI 2b/3, an average procedure time of 37 minutes, and mRS scores ≤ 2 at discharge of 48%. 

“Ace64 is the latest technology improvement in mechanical thrombectomy,” commented Rob T. Lo, MD, in the company’s press release. Dr. Lo is with University Medical Center Utrecht in Utrecht, The Netherlands, a center that participated in the MR CLEAN trial. “With the new Ace64, I am achieving even higher revascularization rates, particularly TICI 3, while reducing procedure times and minimizing overall procedure costs.”