Irish medical device firm, Perfuze announced it has bagged FDA 510(k) clearance to bring its Millipede 070 Aspiration Catheter to the US market.
The Galway-based company said it also received US Food and Drug Administration (FDA) clearance to market the 2nd generation of the Millipede 088 Access Catheter devices designed to treat ischaemic strokes by removing blood clots during endovascular thrombectomy procedures.
The Millipede 070 Aspiration is a device designed to provide neurovascular interventionists with a thrombectomy solution designed to completely restore blood flow to the brain on the first attempt.
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.”
Strokes affect approximately 16 million people each year, resulting in an estimated 6 million deaths globally, with more than 1.5 million European and US patients suffering from an acute ischaemic stroke each year.
Perfuze says that the Millipede 070 is designed with a rib-and-recess surface designed to improve navigability and reduce tip stiffness while maintaining durability.
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Now, the company is enrolling patients for its MARRS pivotal clinical study, which is intended to support further regulatory submissions for the Millipede System.
The MARRS pivotal study is intended to produce data to support an application for FDA clearance for the device’s use in the indication of thrombectomy.
At the same time, the company also received FDA 510(k) clearance for its 2nd generation Millipede 088 Access Catheter, intended to facilitate the insertion and guidance of microcatheters for neurointerventional or diagnostic procedures.
In February 2023 the company acquired the initial FDA 510(k) clearance for the Millipede 088 Access Catheter for use in stroke patients, but is now looking to extend the indications in which it can be used.
A report by GlobalData details how Interventional Neuroradiology is estimated to be worth approximately $3.2bn by the end of 2023, with that figure expected to rise to $4.5bn by the end of 2030.
