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Perfuze® Granted FDA Approval for Advanced Neurovascular Catheters in Stroke Treatment

Thursday, December 21, 2023

Perfuze, a dedicated medical device company focusing on advancing acute ischemic stroke treatment, proudly announces FDA clearance for its groundbreaking Millipede 070 Aspiration Catheter and the second generation of the Millipede 088 Access Catheter. The Millipede 070 introduces pioneering technology to address crucial unmet needs in ischemic stroke treatment, providing a swift and secure mechanism for clot removal. Its distinctive design ensures superior deliverability and procedural efficiency during endovascular thrombectomy procedures, offering an enhanced approach to restoring blood flow to the brain.

Perfuze is committed to equipping neurovascular interventionists with cutting-edge thrombectomy solutions, aiming to maximize successful blood flow restoration on the initial attempt. The recent 510(k) clearance for the Millipede 070 Aspiration Catheter is a significant addition to the company's product lineup, streamlining clot removal and improving clinical outcomes. As part of Perfuze's expanding range of endovascular interventional devices, the Millipede 070 contributes to the ongoing MARRS pivotal clinical study, supporting regulatory submissions for the Millipede System.

In a parallel achievement, Perfuze has obtained 510(k) clearance for the second generation Millipede 088 Access Catheter. This catheter facilitates the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures. These clearances mark notable milestones for Perfuze, demonstrating its unwavering commitment to advancing neurovascular care. Globally, strokes impact around 16 million people annually, resulting in approximately 6 million deaths.

In the United States and Europe, over 1.5 million patients experience acute ischemic stroke each year, with an annual healthcare cost exceeding $100 billion. Recognizing the time-sensitive nature of stroke, Perfuze's innovations aim to address the critical need for timely diagnosis and treatment, as a majority of patients face permanent disability or death without appropriate intervention. Despite recent strides in endovascular treatment, only 10 percent of eligible stroke patients currently receive thrombectomy treatment.