Galway-based Perfuze announced today the completion of patient enrollment in its pivotal U.S. clinical trial for acute ischemic stroke treatment, alongside a strategic addition to its executive leadership team.
The company has successfully enrolled over 180 patients in its MARRS (Millipede Aspiration for Revascularization in Stroke Study) trial ahead of schedule. The study, conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), evaluates the safety and effectiveness of Perfuze's flagship Millipede 088 Superbore aspiration catheter.
The Millipede 088 catheter is designed specifically for rapid and complete clot removal in patients suffering from large vessel occlusion (LVO) strokes, with the aim of improving treatment outcomes while reducing procedural complexity.
Clinical Trial Achievement
The MARRS study enrolled patients across multiple centers in both the United States and Europe. This multi-center approach provides a diverse patient population that strengthens the validity of the trial results.
Dr. Raul Nogueira, Endowed Professor of Neurology and Neurosurgery at University of Pittsburgh School of Medicine and Principal Investigator of the MARRS Study, expressed his appreciation for the collaborative effort:
"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. Nogueira. "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."
Dr. Nogueira emphasized the potential impact of the study, noting that "The data generated from MARRS will provide important insights that have the potential to meaningfully impact the future of stroke treatment."
Strategic Leadership Expansion
In parallel with this clinical milestone, Perfuze announced the appointment of Joe Rotger as Executive Vice President of Sales. Rotger brings over 25 years of commercial leadership experience in the medical device industry, with particular expertise in neurovascular technologies.
His background includes senior positions at leading neurovascular organizations, including Stryker Neurovascular and Boston Scientific, where he successfully led sales teams and drove significant revenue growth.
This strategic hire positions Perfuze to build out its commercial infrastructure as the company prepares for potential market entry following the completion of the MARRS trial and subsequent regulatory review.
Addressing a Critical Medical Need
Acute ischemic stroke remains one of the leading causes of long-term disability and death worldwide. Large vessel occlusion strokes, which account for approximately 20-30% of ischemic strokes, are particularly severe and often result in significant neurological damage without prompt intervention.
Current treatment approaches for LVO strokes include mechanical thrombectomy, which involves the physical removal of the blood clot blocking the vessel. The Millipede 088 catheter represents Perfuze's contribution to advancing this treatment modality.
Wayne Allen, CEO and Co-Founder of Perfuze, highlighted the significance of the enrollment completion: "This marks a major milestone for 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."
Next Steps for Perfuze
With patient enrollment now complete, Perfuze will focus on patient follow-up, data collection, and analysis. The results from the MARRS trial will be crucial for the company's submission to the FDA for potential market approval in the United States.
The addition of Joe Rotger to the executive team signals Perfuze's preparation for commercialization activities, pending favorable trial results and regulatory clearance.
The company's dual announcement of clinical progress and leadership enhancement demonstrates Perfuze's commitment to advancing both its technological innovation and organizational capabilities in the competitive neurovascular market.
