European Data Supporting Penumbra's Ace64 Thrombectomy System Presented at SNIS

July 28, 2015—Penumbra, Inc. announced that results of a European multicenter study of the company’s Ace64 thrombectomy system were revealed in the abstract presentations session at the Society of NeuroInterventional Surgery’s 12th annual meeting in San Francisco, California.

According to the company, the study enrolled 117 patients at nine centers in Germany, the Netherlands, Switzerland, Spain, Denmark, and Italy. Acute ischemic stroke patients with large vessel occlusions treated with the Ace64 device achieved high revascularization rates of 96% Thrombolysis in Cerebral Infarction (TICI) 2b/3, a complete revascularization rate of 62% TICI 3, a fast procedure time of 35 minutes, and modified Rankin scale ≤ 2 at discharge in 46% of patients.

The Ace64 system received European CE Mark approval in December 2014. In the United States, the device received 510(k) clearance from the US Food and Drug Administration in May 2015.

Penumbra’s aspiration thrombectomy devices use a minimally invasive “vacuum” inside the artery to remove blood clot en masse. The Ace64 device, which is built on the Ace tracking technology platform, features a 0.064-inch distal inner diameter and a 0.068-inch proximal inner diameter that is designed to evacuate large clot burdens from the neurovasculature, stated the company.

In the company’s press release, study investigator Prof. Werner Weber, MD, commented, “We were able to show that Ace64 achieved high revascularization rates, particularly TICI 3 scores. 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.” Prof. Weber is Director of the Institute for Diagnostic and Interventional Radiology, Neuroradiology and Nuclear Medicine at the University Hospital Knappschaftskrankenhaus Bochum, Germany.

Blaise Baxter, MD, Chief of Radiology at Erlanger Hospital in Chattanooga, Tennessee, added, “The multicenter European experience has demonstrated the effectiveness of Ace64. 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.”