Penumbra, Inc. (NYSE: PEN) has enrolled the first patient in its FORWARD study, an international, prospective, multi-center trial evaluating mechanical thrombectomy for distal acute ischemic stroke, according to a company press release.

The first patient was treated by Keith Woodward, M.D., a neurointerventional radiologist at Vista Radiology in Knoxville, Tenn. The study plans to enroll up to 250 participants across approximately 40 sites.

FORWARD — an acronym for Functional Outcomes in Real-World Treatment and Revascularization of Non-dominant and Distal M2 Occlusions — will collect safety and efficacy data on mechanical thrombectomy, including computer assisted vacuum thrombectomy (CAVT) and modulated aspiration, for strokes caused by distal vessel occlusions. The study will include patients treated with medical management alone and those treated with a combination of mechanical thrombectomy and medical management.

The study will evaluate Penumbra's RED reperfusion catheter portfolio, including THUNDERBOLT, a CAVT platform that recently received CE Mark and FDA clearance. Penumbra describes THUNDERBOLT as the first CAVT platform to deliver modulated aspiration for acute ischemic stroke.

Distal vessel occlusions account for roughly 25–40% of acute ischemic strokes, with M2 occlusions estimated to occur in approximately 3–7% of such cases, representing an estimated 21,000–66,000 M2 strokes annually, according to published research cited by the company.

"Distal occlusions are among the more difficult strokes to treat as medical interventions for patients in this population have historically provided limited benefit," said Nitin Goyal, M.D., co-principal investigator of FORWARD and endovascular neurologist at Semmes-Murphey Neurologic and Spine Institute in Memphis, Tenn.

Alex Spiotta, M.D., co-principal investigator and chief of neurosurgery at the Medical University of South Carolina, said the results will help inform physicians on treatment selection for stroke patients with M2 occlusions.