Millipede 070 Aspiration Catheter is designed for the safe and rapid removal of clots and addresses critical unmet needs in the treatment of stroke, while Millipede 088 Access Catheter is designed for the safe insertion and guidance of microcatheters during neurointerventional or diagnostic operations
Perfuze has secured FDA clearance for two stroke treatment catheters. (Credit: Business Wire)
Ireland-based Perfuze has received the US Food and Drug Administration (FDA) approval for the Millipede 070 Aspiration Catheter and the second generation of the Millipede 088 Access Catheter for stroke treatment.
Millipede 070 Aspiration Catheter is designed for the safe and rapid removal of clots and addresses critical unmet needs in the treatment of stroke.
The new catheter is said to offer a more improved method of re-establishing blood flow to the brain during endovascular thrombectomy treatments.
It is engineered for superior deliverability and high procedural efficiency, according to Perfuze.
Millipede 070 is part of the firm’s expanding range of endovascular interventional devices that are intended to enhance and improve stroke treatment.
Currently, the medical device firm is enrolling patients for the MARRS clinical trial, which will help with the Millipede System’s regulatory applications.
Perfuze CEO Wayne Allen said: “Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions to maximise their opportunity to completely restore blood flow to the brain on their first attempt.
“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.”
Furthermore, Perfuze’s second-generation Millipede 088 Access Catheter also secured 510k clearance.
It is designed for the safe insertion and guidance of microcatheters during neuro-interventional or diagnostic operations.
Initially, Millipede 088 received the US FDA 510(k) clearance last year.
The medical device company works to improve all aspects of stroke treatment, from vessel access to thrombectomy, using a physician-led approach to device innovation.
Perfuze said that the 510(k) approvals represent a significant accomplishment for the business and demonstrate its dedication to improving neurovascular treatment.
Last year, the Irish medical device firm raised €22.5m in a Series A financing round to develop its catheter-based aspiration technology.