Perfuze® Announces FDA Clearances for Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment

GALWAY, Ireland--(BUSINESS WIRE)-- Perfuze, a private medical device company dedicated to developing pioneering technology to treat acute ischemic stroke, proudly announces FDA clearance for the Millipede 070 Aspiration Catheter and the 2nd generation of the Millipede 088 Access Catheter.

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The Millipede 070 Aspiration Catheter is built upon a pioneering, distinctive technology that enables physicians to address critical unmet needs in ischemic stroke treatment. It is designed to remove clots rapidly and safely. This novel, unique catheter is designed for superior deliverability and high procedural efficiency, making it a more refined approach for restoring blood flow to the brain during endovascular thrombectomy procedures.

“In our initial experience with Millipede 070, the system easily delivered to the target occlusion allowing rapid, effective and safe reperfusion,” stated David Fiorella, Director of the Stony Brook Cerebrovascular Center, NY, USA. Millipede 070 has a unique design with a rib-and-recess surface architecture designed to improve navigability and reduce tip stiffness, while maintaining durability.

“Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximize their opportunity to completely restore blood flow to the brain on their first attempt,” said Wayne Allen, CEO of Perfuze. “The 510(k) clearance for the Millipede 070 Aspiration Catheter is a key addition to our portfolio of products and is designed to simplify removal of the clot and improve clinical outcomes.”

The Millipede 070 Aspiration Catheter is part of Perfuze’s growing catalog of endovascular interventional devices designed to refine and improve stroke treatment. The company is currently enrolling patients for the MARRS pivotal clinical study, which will support regulatory submissions for the Millipede System.

Additionally, Perfuze received 510k clearance for its 2nd generation Millipede 088 Access Catheter. This catheter is designed to facilitate the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures. The Millipede 088 Access Catheter initially received U.S. FDA 510(k) clearance in 2022. Perfuze takes a physician-led approach to device innovation, working to advance all aspects of stroke treatment from vessel access through to thrombectomy. These 510(k) clearances are a major milestone for the company, underscoring its commitment to continually advancing the field of neurovascular care.

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, just 10 percent of eligible stroke patients receive thrombectomy treatment today.

About Perfuze

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.

For more information, please visit www.perfuze.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20231220858228/en/

Contacts

Wayne Allen, CEO
Perfuze
Email: wayne@perfuze.com

Source: Perfuze

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