Perfuze announced FDA clearance for the Millipede 070 Aspiration Catheter and the second generation of the Millipede 088 Access Catheter.

The Millipede 070 Aspiration Catheter is built upon a distinctive technology that enables physicians to address critical unmet needs in ischemic stroke treatment. It is designed to remove clots rapidly and safely. The 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.

Millipede 070 has a unique design with a rib-and-recess surface architecture designed to improve navigability and reduce tip stiffness, while maintaining durability.

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% of eligible stroke patients receive thrombectomy treatment today.

“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.