Study of Penumbra’s ACE64 Demonstrates High Revascularization Rates, Quick Procedure Times in Stroke Patients
European Multicenter Study Results Presented at Society of NeuroInterventional Surgery 12th Annual Meeting
SAN FRANCISCO, Calif. – July 28, 2015 – Penumbra, Inc., a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices, today announced that the results of the European multi-center study of the company’s ACE64 thrombectomy system were presented in the Abstract Presentations Session at the Society of NeuroInterventional Surgery (SNIS) 12th Annual Meeting in San Francisco. ACE64 is the most recent innovation in mechanical thrombectomy technology since the landmark MR CLEAN and subsequent confirmatory trials demonstrated the efficacy of endovascular treatment for patients with acute ischemic stroke.
“We were able to show that ACE64 achieved high revascularization rates, particularly TICI 3 scores,” explained Professor Werner Weber, MD, Director of the Institute for Diagnostic and Interventional Radiology, Neuroradiology and Nuclear Medicine at the University Hospital Knappschaftskrankenhaus Bochum, Germany, and investigator in the study. “In Europe, my colleagues and I have long used many different variations of stent retrievers. ACE64 offers improvements over earlier technology by quickly removing clot en masse, often in a single attempt, to increase TICI 3, reduce procedure time and minimize the need for adjunctive devices. Working proximal to the occlusion, ACE64 also decreases clot disruption to create a favorable safety profile.”
In the ACE64 study, acute ischemic stroke patients with large vessel occlusions achieved high revascularization rates of 96 percent Thrombolysis in Cerebral Infarction (TICI) 2b/3, with complete revascularization at 62 percent TICI 3, a fast procedure time of 35 minutes and modified Rankin Scale (mRS) ≤2 at discharge of 46 percent.
The study enrolled 117 patients at nine centers in Germany, the Netherlands, Switzerland, Spain, Denmark and Italy.
“The multi-center European experience has demonstrated the effectiveness of ACE64,” said Blaise Baxter, MD, Chief of Radiology at Erlanger Hospital in Tennessee. “The innovative technology of the ACE64 allows reliable, easy tracking of a large bore aspiration catheter. By using ACE64 direct aspiration frontline, we achieve high revascularization rates and save on procedural cost while still maintaining the option to use adjunctive devices if needed. ACE64 is not only effective but also a very versatile stroke platform.”
Penumbra’s aspiration thrombectomy devices use a minimally invasive “vacuum” inside the artery to remove blood clot en masse. ACE64 features a 0.064” distal inner diameter and a 0.068” proximal inner diameter that is 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 510(k) clearance from the U.S. Food and Drug Administration in May 2015. ACE64 provides a very versatile platform for intra-arterial stroke therapy, working easily with adjunct devices, if needed, 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. The company has a broad portfolio of products that address challenging medical conditions and significant clinical need across two major markets, neuro and peripheral vascular. Penumbra has over 1,000 employees and sells its products to hospitals primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets.
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