ALAMEDA, Calif., July 7, 2026
Penumbra, Inc., a global leader in thrombectomy technologies, has announced the first patient enrollment in its FORWARD (Functional Outcomes in Real-World Treatment and Revascularization of Non-dominant and Distal M2 Occlusions) Study, an important international clinical investigation evaluating mechanical thrombectomy and Computer Assisted Vacuum Thrombectomy (CAVT™) for patients experiencing distal acute ischemic stroke. The prospective, multicenter, real-world study represents a significant advancement in stroke research and is designed to generate clinical evidence supporting improved treatment options for patients with M2 occlusions, a challenging form of ischemic stroke that has historically had limited interventional therapies. The first patient was treated by Dr. Keith Woodward at Vista Radiology in Knoxville, Tennessee, marking the official launch of Penumbra’s latest global clinical research initiative. Stroke remains one of the leading causes of death and long-term disability worldwide, making continued innovation in minimally invasive neurovascular therapies essential for improving patient outcomes.
FORWARD Study Evaluates Advanced Thrombectomy Technology
The FORWARD Study will enroll up to 250 participants across approximately 40 leading clinical centers worldwide and will compare outcomes among patients receiving standard medical management alone and those treated with mechanical thrombectomy combined with medical therapy. Investigators will evaluate the safety, effectiveness, and real-world clinical performance of Penumbra’s advanced RED reperfusion catheter portfolio, including THUNDERBOLT™, the first Computer Assisted Vacuum Thrombectomy (CAVT) platform featuring modulated aspiration technology specifically developed for acute ischemic stroke.
This next-generation technology is designed to detect, fatigue, and completely remove blood clots while navigating deeper into the cerebral vasculature, potentially expanding the benefits of mechanical thrombectomy to patients with distal vessel occlusions. Clinical leaders participating in the study believe the research could reshape current treatment strategies for patients who previously had limited therapeutic options due to the complexity of distal brain vessel anatomy.
Clinical Evidence Aims to Expand Stroke Care
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According to Penumbra, distal vessel occlusions account for approximately 25–40% of acute ischemic strokes, while M2 occlusions represent an estimated 21,000 to 66,000 stroke cases annually. Although mechanical thrombectomy has become the standard of care for large vessel occlusions, its role in treating distal occlusions continues to evolve as technology advances. The FORWARD Study seeks to generate high-quality clinical evidence demonstrating whether modern thrombectomy systems can safely improve neurological outcomes in this patient population. THUNDERBOLT™, which recently received both FDA clearance and CE Mark certification, incorporates innovative modulated aspiration technology to improve clot removal efficiency while minimizing procedural complexity. Company leadership emphasized that the study reflects Penumbra’s long-standing commitment to advancing evidence-based neurovascular care through continuous clinical innovation.
By combining real-world clinical data with cutting-edge thrombectomy technology, the FORWARD Study has the potential to guide future physician decision-making, influence treatment guidelines, and expand access to minimally invasive stroke interventions. The successful enrollment of the first patient represents an important milestone in Penumbra’s mission to improve outcomes for patients with acute ischemic stroke while strengthening the growing body of evidence supporting advanced mechanical thrombectomy technologies. As patient enrollment continues across international sites, investigators anticipate the study will provide valuable insights into the safety, efficacy, and broader clinical application of Computer Assisted Vacuum Thrombectomy in one of the most complex areas of modern neurovascular medicine.
Source: Penumbra press release
