
Perfuze Announces Completion of Enrollment in Pivotal US Clinical Study and Appointment of Joe Rotger as Executive Vice President of Sales
The MARRS pivotal study, conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), has successfully enrolled over 180 patients across multiple centers in the United States and Europe ahead of schedule. The study evaluates the safety and effectiveness of the Millipede 088, Perfuze's flagship Superbore aspiration catheter. Designed for rapid and complete clot removal in patients suffering from large vessel occlusion (LVO) strokes, Millipede 088 aims to improve stroke treatment outcomes and reduce procedural complexity.
'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 Dr. Raul Nogueira, Endowed Professor of Neurology and Neurosurgery at University of Pittsburgh School of Medicine and 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, 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.'
Additionally, Perfuze is pleased to welcome Joe Rotger as Executive Vice President of Sales. Joe has over 25 years of commercial leadership experience in the medical device industry, with a strong focus on neurovascular technologies. He has held senior positions at prominent neurovascular organizations, including Stryker Neurovascular and Boston Scientific, where he successfully led sales teams and drove significant revenue growth.
Expressing his enthusiasm about the new role, Rotger stated, 'I am excited to join Perfuze at this critical juncture. 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.'
Perfuze is currently in a Limited Market Release (LMR) in the United States 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 FDA submission for expanded use of the Millipede System in stroke thrombectomy.
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About Perfuze
Perfuze is a privately held medical device company headquartered in Galway, Ireland, dedicated to developing innovative catheter-based aspiration technology for treating acute ischemic stroke. With a mission to simplify stroke treatment, Perfuze's proprietary Millipede System delivers powerful clot retrieval performance through a simple, elegant design. The company's vision is to significantly improve clinical outcomes for stroke patients worldwide.
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