Perfuze celebrates a ‘major milestone’ for new-look stroke catheter
Perfuze, a medical device company based out of Ireland, has wrapped up enrollment for a pivotal investigational device exemption (IDE) trial focused on the safety and effectiveness of its Millipede 088 superbore aspiration catheter.
The Millipede 088 was designed to treat large vessel occlusion (LVO) stroke patients by “ingesting” the blood clot as opposed to carrying it through the patient’s blood vessels. According to Perfuze, this “first pass effect” limits the risk of vessel damage or other procedure-related complications.
The MARRS pivotal trial has now enrolled 180 adult patients throughout the United States and Europe. The study’s primary outcomes are successful reperfusion and symptomatic intracerebral hemorrhage within 24 hour of treatment. While the Millipede 088 has already received U.S. Food and Drug Administration clearance, the company hopes data from MARRS will support an expanded approval for the device in the future.
“This marks a major milestone for Perfuze,” Wayne Allen, CEO and co-founder of Perfuze, said in a statement. “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.”
“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,” added MARRS principal investigator Raul Nogueira, MD, a professor with University of Pittsburgh School of Medicine and former president of the Society of Vascular and Interventional Neurology. “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.”