Featuring 0.064 distal inner diameter and 0.068 proximal inner diameter, ACE64 has been designed to evacuate large clot burdens from the neurovasculature.
According to the firm, the system’s MR Clean and subsequent confirmatory trials showed the efficacy of endovascular treatment for patients with acute ischemic stroke.
The study investigator Dr Werner Weber said: "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."
In the ACE64 trial, acute ischemic stroke patients with large vessel occlusions reached revascularization rates of 96% Thrombolysis in Cerebral Infarction (TICI) 2b/3, with complete revascularization at 62% TICI 3, said Penumbra.
The company enrolled 117 patients at nine centers in Germany, the Netherlands, Switzerland, Spain, Denmark and Italy.
With the help of ACE tracking technology platform, ACE64 allows easy delivery and enables optimal clot engagement for even faster and more complete clot removal.
ACE64 obtained CE mark approval in December 2014 and 510(k) approval from the US Food and Drug Administration in May 2015.
