FDA Clears Penumbra’s ACE64 Thrombectomy System for Stroke Treatment

Penumbra, Inc., says its ACE64 aspiration thrombectomy system has received U.S. FDA 510(k) marketing clearance for the revascularization of large vessel occlusions in patients with acute ischemic stroke.

Background

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.

ACE64 features the largest lumen aspiration thrombectomy device on the market with a 0.064” distal inner diameter and a 0.068” proximal inner diameter, designed to evacuate large clot burdens from the neurovasculature. Built on the innovative ACE tracking technology platform, Penumbra says its ACE64 system boasts exceptionally easy delivery, enabling optimal clot engagement for even faster and more complete clot removal.
Its unique construction leverages breakthrough technology in materials science enabling physicians to bring the most powerful clot extraction capability directly to the occlusion and remove clot en masse.

ACE64 received CE Mark in December 2014 and is intended for acute ischemic patients with large vessel occlusive disease within eight hours of symptom onset.

Penumbra is positioning its ACE 64 system as the foundation of intra-arterial therapy using aspiration thrombectomy for acute ischemic stroke patients, working seamlessly with adjunct devices to simplify procedures and lower procedural costs.

Underpinning the FDA clearance is the superbly named MR CLEAN trial, subsequently confirmed in additional randomized controlled stroke trials.

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.

Investigator comments

“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.”

Company comments

“We are at an exciting moment in history when the effectiveness of mechanical thrombectomy is now firmly established, allowing the stroke community to focus on optimizing the delivery of care in stroke and improving patient outcomes,” said Adam Elsesser, chairman and chief executive officer. “At Penumbra, we are continuing the pace of innovation to bring ever more effective tools to physicians in the fight against a devastating disease affecting so many patients worldwide.”

Source: Penumbra, Inc.

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