Perfuze has announced two “significant milestones” in its mission to improve stroke care: the completion of patient enrolment in its US pivotal investigational device exemption (IDE) clinical trial, MARRS, and the appointment of medtech executive Joe Rotger as the company’s executive vice president of sales.
The MARRS pivotal study—conducted under an IDE from the US Food and Drug Administration (FDA)—has successfully enrolled more than 180 patients across multiple centres in the USA and Europe ahead of schedule.
The study is evaluating the safety and effectiveness of the Millipede 088, Perfuze’s flagship super-bore aspiration catheter. Designed for rapid and complete clot removal in patients suffering from large vessel occlusion (LVO) strokes, the device aims to improve stroke treatment outcomes and reduce procedural complexity, as stated in a Perfuze press release.
“I would like to extend my sincere congratulations to all the hospitals and clinical investigators involved in the MARRS study for their exceptional commitment and collaboration throughout the trial,” said Raul Nogueira (University of Pittsburgh School of Medicine, Pittsburgh, USA), principal investigator of the MARRS study. “Your dedication has been instrumental in executing a rigorous and high-quality study. Most importantly, I want to express my deepest gratitude to the stroke patients and their families who participated. Their courage and generosity in the face of acute illness made this crucial research possible. The data generated from MARRS will provide important insights that have the potential to meaningfully impact the future of stroke treatment.”
“This marks a major milestone for Perfuze,” added Wayne Allen, chief executive officer (CEO) and co-founder of Perfuze. “Completion of enrolment in MARRS brings us closer to making the Millipede system available to stroke physicians across the USA. We’re incredibly grateful to the investigators, clinical teams and, most importantly, the patients who participated in the study.”
Additionally, Perfuze has welcomed Joe Rotger as executive vice president of sales. Rotger has over 25 years of commercial leadership experience in the medical device industry, with a focus on neurovascular technologies. He has held senior positions at Stryker Neurovascular and Boston Scientific, where he successfully led sales teams and drove significant revenue growth.
“I am excited to join Perfuze at this critical juncture,” Rotger commented. “The opportunity to introduce innovative devices such as the Millipede and Zipline catheters to the US stroke market is immense, and I look forward to working with the team to make a meaningful impact on stroke care.”
Perfuze is currently in a limited market release (LMR) in the USA with its FDA-cleared Millipede 088 access catheter, Millipede 070 aspiration catheter and Zipline family of delivery assist catheters. Insights from MARRS will support a future US FDA submission for expanded use of the Millipede system in stroke thrombectomy, according to Perfuze.
