Alameda, California–based Penumbra’s real-world, prospective, multi-center study will collect safety and efficacy data on mechanical thrombectomy. That includes computer-assisted vacuum thrombectomy (CAVT) and modulated aspiration in the management of acute ischemic stroke with distal occlusions.
Dr. Keith Woodward, a neurointerventional radiologist at Vista Radiology in Knoxville, Tennessee, treated the first FORWARD patient.
FORWARD (Functional Outcomes in Real‑World Treatment and Revascularization of Non-dominant and Distal M2 Occlusions) will enroll up to 250 participants across approximately 40 sites. Penumbra aims to evaluate its RED reperfusion portfolio, which includes the Thunderbolt CAVT platform.
Thunderbolt expands the company’s CAVT portfolio to address acute ischemic stroke through the use of modulated aspiration. It recently picked up both FDA clearance and CE mark approval. Penumbra — set to be acquired by Boston Scientific for $14.5 billion — said it’s the first CAVT platform to deliver modulated aspiration for acute ischemic stroke, to address M2 occlusions.
FORWARD includes patients treated with medical management alone and those treated with mechanical thrombectomy and medical management.
Commentary from Penumbra leadership and study investigators
Dr. James F. Benenati, chief medical officer at Penumbra, said:
“FORWARD will deepen the medical community’s understanding of how mechanical thrombectomy, specifically our latest catheter and CAVT technology, can more effectively address the complexity of M2 stroke. Penumbra’s commitment to clinical research offers more insight into how our innovations translate to real-world patient outcomes, reinforcing our mission to develop the most meaningful treatment options for challenging medical conditions.”
Dr. Alex Spiotta, co-principal investigator and chief of the neurosurgery department and director of neuroendovascular surgery at the Medical University of South Carolina, said:
“Enrolling the first patient in FORWARD is an important milestone in understanding the true impact of mechanical thrombectomy on distal occlusions. We have already seen how mechanical thrombectomy can positively benefit patients with acute ischemic stroke by rapidly restoring blood flow to the brain and improve patient outcomes. The results of this study will help inform physicians on treatment selection for stroke patients with M2 occlusions, potentially supporting wider adoption of mechanical thrombectomy for this challenging condition.”
Dr. Nitin Goyal, co-principal investigator and endovascular neurologist at Semmes-Murphey Neurologic and Spine Institute in Memphis, Tennessee, said:
“Distal occlusions are among the more difficult strokes to treat as medical interventions for patients in this population have historically provided limited benefit. FORWARD is a prospective study designed to evaluate whether that paradigm can change. Mechanical thrombectomy has an established safety profile and a strong track record in treating large vessel occlusions. With the latest advancements designed for navigating deeper into the brain, the FORWARD study aims to determine whether these same benefits can extend to distal occlusions and help pave the way for an important treatment option for a patient population that has limited choices.”
