Perfuze has announced commencement of enrolment in its pivotal MARRS study—a multicentre trial set to evaluate the performance of aspiration thrombectomy with the company’s Millipede system for revascularisation in acute ischaemic stroke. The first patient was enrolled at Stony Brook University Hospital in Stony Brook, USA.
“I am delighted to begin enrolment in the MARRS pivotal study,” said David Fiorella (Stony Brook Cerebrovascular Center, Stony Brook, USA). “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.”
MARRS is an interventional, open-label, single-arm, prospective pivotal study that will enrol up to 220 patients at 25 sites across the USA and Europe. The study will evaluate the performance and safety of the Millipede system in patients with acute ischaemic stroke, and its results are intended to provide clinical evidence to support an application for US Food and Drug Administration (FDA) clearance, according to Perfuze.
Ameer Hassan (Valley Baptist Medical Center, Harlingen, USA) and Marc Ribó (Vall d’Hebron Hospital, Barcelona, Spain) are the principal investigators of the study.
“Super-bore aspiration has the potential to significantly improve reperfusion in stroke patients, and the Millipede system represents an elegant approach to treatment,” said Hassan.
“We are privileged to embark on our pivotal clinical trial with the dedicated MARRS investigators and anticipate continued momentum in our enrolment as the study progresses,” said Wayne Allen, co- founder and chief executive officer of Perfuze. “We firmly believe that the Millipede system has the potential to redefine the outcomes of neurovascular aspiration thrombectomy for large vessel occlusions.”
The Perfuze Millipede 088 access catheter received US FDA 510(k) clearance for neurovascular access in 2022, and a CE-mark for first-line aspiration thrombectomy in the European Union (EU) in 2021, a press release from the company notes.