Perfuze has enrolled the first patient in the MARRS pivotal study evaluating the performance and safety of its Millipede system for the treatment of acute ischemic stroke.
Perfuze’s Millipede is an access catheter system that guides microcatheters during neuro-interventional or diagnostic procedures. The device is US Food and Drug Administration (FDA) cleared for neurovascular access and CE marked for first-line aspiration thrombectomy.
Ireland-based Perfuze stated that the MARRS pivotal study is intended to produce data to support an application for FDA clearance for thrombectomy, as per a 2 November press release.
MARRS is an interventional, open-label, single-arm, multi-centre, prospective pivotal study. Perfuze aims to enrol up to 220 patients across 25 sites in the US and Europe.
Thrombectomy is a type of surgery used to remove a blood clot from an occluded blood vessel. The procedure can be used to treat strokes caused by a clot in a large artery in the brain. However, it has a time-limited window and is only effective if conducted within 4.5 hours after a stroke.
According to a market model by GlobalData, Medtronic owns the biggest market share of neurovascular thrombectomy devices, a 30.3% stake. Stryker owns 20.4%, followed by J&J and Terumo. The market was estimated to be worth $788m in 2022, with it expected to grow to $1.9bn by 2033.
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The first patient was enrolled at the New York Stony Brook Cerebrovascular Centre.
The centre’s director Dr David Fiorella said: “It is an exciting opportunity to evaluate the next wave of thrombectomy technology with the possibility of improving interventional stroke treatment. I anticipate the results of this study will benefit future stroke patients.”