Galway, Ireland. 2 November 2023. Perfuze, a private medical device company dedicated to developing pioneering technology to treat acute ischemic stroke, announced commencement of enrollment in its pivotal MARRS (Millipede AspiRation for Revascularization in Stroke) clinical study. MARRS is a multi-center trial to evaluate the performance of the Millipede System. The first patient was enrolled at Stony Brook University Hospital in Stony Brook, NY.
“I am delighted to begin enrollment in the MARRS pivotal study” said Dr David Fiorella, Director of the Stony Brook Cerebrovascular Center, NY. “It is an exciting opportunity to evaluate the next wave of thrombectomy technology with the possibility of improving interventional stroke treatment. I anticipate the results of this study will benefit future stroke patients.”
MARRS is an interventional, open label, single arm, multi-center, prospective pivotal study and will enroll up to 220 patients at 25 sites across the United States and Europe. The study will evaluate the performance and safety of the Millipede System in patients with acute ischemic stroke. Results of the study are intended to provide clinical evidence to support an application for FDA clearance. Dr Ameer Hassan (Valley Baptist Medical Center, TX, USA) and Dr Marc Ribo (Vall d’Hebron Hospital, Barcelona, Spain) are the Principal Investigators of the study. Dr Hassan commented “Superbore aspiration has the potential to significantly improve reperfusion in stroke patients, and the Millipede System represents an elegant approach to treatment.”
“We are privileged to embark on our pivotal clinical trial with the dedicated MARRS investigators and anticipate continued momentum in our enrollment as the study progresses” said Wayne Allen, Co- Founder and CEO of Perfuze. “We firmly believe that the Millipede System has the potential to redefine the outcomes of neurovascular aspiration thrombectomy for large vessel occlusions.”
The Perfuze Millipede 088 Access Catheter received U.S. FDA 510(k) clearance for neurovascular access in 2022, and CE Mark for first-line aspiration thrombectomy in the European Union in 2021. Each year, strokes affect about 16 million people resulting in an estimated 6 million deaths globally. In the United States and Europe, more than 1.5 million patients suffer from acute ischemic stroke each year, with an annual healthcare cost exceeding $100 billion. Stroke is a critically time-sensitive disease and without appropriate diagnosis and treatment, a majority of patients suffer permanent disability or death. Despite recent advances in life-saving endovascular treatment, only approximately 10 percent of eligible stroke patients receive thrombectomy treatment today.
Based in Galway, Ireland, Perfuze has developed Superbore aspiration technology (50% increase in surface area at the catheter tip facilitating increased vacuum power) that is designed to navigate complex neurovascular anatomy. The system is designed to provide superior navigation in challenging anatomy and robust support, with unparalleled simplicity and speed. The company’s pipeline of products is designed to facilitate fast, complete clot removal during acute ischemic stroke. Perfuze is committed to continuing its research and development efforts to advance the field of neurovascular care. www.perfuze.com
For further information, please contact Vicky La Touche-Price in Seroba on +3531 6334028.