Penumbra ACE64 Cleared for Marketing by U.S. Food & Drug Administration for Acute Ischemic Stroke Patients
New Advancement in Intra-Arterial Treatment of Stroke
ALAMEDA, Calif. – May 27, 2015 – Penumbra, Inc., a global interventional therapies company and innovator in intra-arterial stroke therapy, today 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 is the most advanced innovation in thrombectomy technology since these trials were conducted. With a unique construction that leverages breakthrough technology in materials science, ACE64 enables physicians to bring the most powerful clot extraction capability directly to the occlusion and remove clot en masse. 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.”
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.
“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.”
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, ACE64 accomplishes exceptionally easy delivery, enabling optimal clot engagement for even faster and more complete clot removal. 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. Aspiration thrombectomy with the ACE64 represents the foundation of intra-arterial therapy for acute ischemic stroke patients, working seamlessly with adjunct devices to simplify procedures and lower procedural costs.
Penumbra, Inc. (www.penumbrainc.com) is a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices. We have a broad portfolio of products that address challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. The conditions that we address include, among others, ischemic stroke, hemorrhagic stroke and various peripheral vascular conditions that can be treated through thrombectomy and embolization. Penumbra has over 850 employees and its global headquarters is located in Alameda, California, with sales operations around the world.
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