Friday, November 03, 2023
Perfuze, a privately held medical device company focused on pioneering technology for the treatment of acute ischemic stroke, has announced the commencement of patient enrollment in its pivotal clinical trial known as MARRS (Millipede AspiRation for Revascularization in Stroke). This trial is a multi-center investigation designed to assess the performance of the Millipede System, and it marked the enrollment of its first patient at Stony Brook University Hospital in Stony Brook, New York.
The MARRS study is an interventional, open-label, single-arm, multi-center, prospective pivotal study that aims to enroll a maximum of 220 patients across 25 clinical sites in the United States and Europe. The primary objective of this study is to evaluate both the performance and safety of the Millipede System in patients diagnosed with acute ischemic stroke. The study results are intended to provide the clinical evidence required to support an application for FDA clearance.
Superbore aspiration, a technique with the potential to significantly enhance reperfusion in stroke patients, is central to the Millipede System's approach to treatment. This innovative technology is poised to make a valuable contribution to the management of acute ischemic stroke by improving blood flow restoration to the affected brain tissue.