Latest news with #Perfuze
Business Wire
22-04-2025
- Business
- Business Wire
Perfuze Announces Completion of Enrollment in Pivotal US Clinical Study and Appointment of Joe Rotger as Executive Vice President of Sales
GALWAY, Ireland--(BUSINESS WIRE)-- Perfuze, a leader in next-generation catheter-based technology for the treatment of acute ischemic stroke, today announced two significant milestones in its mission to improve stroke care: 1) the completion of patient enrollment in its U.S. pivotal IDE clinical trial, MARRS (Millipede Aspiration for Revascularization in Stroke Study), and 2) the appointment of seasoned medtech executive 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. For more information, visit 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.
Yahoo
13-03-2025
- Business
- Yahoo
Perfuze Receives FDA 510(k) Clearance for Zipline™ Access Catheters and Secures €22M in Additional Funding
GALWAY, Ireland, March 13, 2025--(BUSINESS WIRE)--Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA 510(k) clearance for its Zipline™ Access Catheters. This regulatory milestone strengthens Perfuze's growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischemic strokes with greater speed, ease, and precision. In addition, Perfuze has secured €22 million in follow-on funding in a round led by existing investors including Earlybird, EQT Life Sciences, Seroba and SV Health. Transforming Stroke Care with Zipline™ Every minute counts in stroke care. As a stroke progresses, human brain tissue is quickly and permanently lost, making urgent therapeutic intervention critical. The Zipline™ Access Catheters are engineered to enhance the trackability and delivery of large (070) and superbore (088) aspiration catheters, simplifying neurointerventional procedures and enabling faster, more efficient stroke treatment. By providing increased support and navigational ease, Zipline™ aims to optimize clot removal efficiency, ultimately improving procedural success rates and patient outcomes. The FDA clearance marks a significant step forward in Perfuze's mission to simplify and improve stroke treatment and outcomes through technological innovation. "The FDA clearance of our Zipline™ Access Catheter is a testament to Perfuze's commitment to developing best-in-class stroke solutions," said Wayne Allen, CEO of Perfuze. "This regulatory approval strengthens our growing presence in the U.S. market and supports our vision of delivering novel, effective, and easy-to-use technologies that can make a real difference in stroke care." Dr. Jay Dolia, Assistant Professor, Neurology, Emory University School of Medicine stated: "The Zipline catheters represent an innovative technology that I believe will simplify stroke intervention, reduce costs and accelerate reperfusion. In my initial experience, they have enabled rapid clot access and aspiration, even in complex anatomy." Fueling Growth: €22 Million Investment to Drive Commercial Rollout Perfuze has successfully closed a €22 million funding round, led by existing investors. This investment will support the Limited Market Release of the Zipline™ and Millipede™ catheters while advancing ongoing clinical and R&D initiatives to further enhance stroke treatment capabilities. Perfuze has initiated a Limited Market Release in the U.S. in prestigious US Comprehensive Stroke Centres. The company's growing portfolio is designed to provide physicians with highly effective tools to simplify stroke treatment and improve patient outcomes. "The continued support from our investors underscores the confidence in Perfuze's technology and vision," stated Perfuze Chairperson, Hooman Hakami. "With this funding, we are well-positioned to initiate our U.S. Limited Market Release and drive adoption in select centers of our transformative stroke treatment solutions." For more information about Perfuze and its innovative stroke treatment solutions, visit About Perfuze Perfuze is a medical device company headquartered in Galway, Ireland, dedicated to developing next-generation catheter-based aspiration technology for the treatment of acute ischemic stroke. The company's proprietary platform is designed to maximize clot removal efficiency, enhance procedural simplicity, and improve clinical outcomes. View source version on Contacts Media Contact: Freskida GoniCommunications Consultant +44 7473678178
