Perfuze announced it completed enrollment in its U.S. FDA investigational exemption (IDE) trial evaluating its stroke treatment. Galway, Ireland-based Perfuze also shared a new personnel appointment, naming Joe Rotger EVP of sales.
According to a news release, Perfuze completed enrollment in the MARRS (millipede aspiration for revascularization in stroke) study. The study enrolled more than 180 patients in the U.S. and Europe ahead of schedule. It evaluates the effectiveness of the Millipede 088, the company’s flagship superbore aspiration catheter.
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Perfuze designed the catheter for rapid and complete clot removal in patients suffering from large vessel occlusion (LVO) strokes. The company aims to improve stroke treatment outcomes and reduce procedural complexity. The catheter is currently in a limited U.S. market release along with the Millipede 070 aspiration catheter and Zipline family of delivery assist catheters. Perfuze hopes to gain insight from MARRS to support an FDA submission for expanded use in stroke thrombectomy.
“This marks a major milestone for Perfuze,” added Wayne Allen, CEO and co-founder of Perfuze. “Completion of enrollment in MARRS brings us closer to making the Millipede system available to stroke physicians across the U.S. We’re incredibly grateful to the investigators, clinical teams, and most importantly, the patients who participated in the study.”
Perfuze also added significant medtech experience to its leadership team with the appointment of Rotger. He held senior positions at neurovascular organizations including Stryker and Boston Scientific. At those stops, he led sales teams and drove significant revenue growth.
“I am excited to join Perfuze at this critical juncture,” Rotger said. “The opportunity to introduce innovative devices such as the Millipede and Zipline catheters to the U.S. stroke market is immense, and I look forward to working with the team to make a meaningful impact on stroke care.”
