ALAMEDA, California, July 22, 2026
Penumbra, Inc. has announced positive results from the THUNDER Investigational Device Exemption (IDE) study, demonstrating that its THUNDERBOLT™ Computer Assisted Vacuum Thrombectomy (CAVT™) System is safe and effective for treating patients with emergent large vessel occlusion (ELVO) stroke. The late-breaking data, presented at the Society of NeuroInterventional Surgery (SNIS) 23rd Annual Meeting, highlight the performance of the first and only CAVT device for stroke treatment, showing high revascularization rates, rapid procedure times, complete clot ingestion, and low complication rates. The findings reinforce THUNDERBOLT’s potential to advance mechanical thrombectomy, offering physicians a next-generation technology designed to rapidly restore blood flow while improving clinical outcomes for patients experiencing acute ischemic stroke (AIS).
THUNDER Study Meets Primary Performance Goal
The prospective, single-arm, multicenter THUNDER study enrolled 216 patients across 29 U.S. clinical centers to evaluate the safety and effectiveness of THUNDERBOLT™ in patients with ELVO stroke. The study successfully met its predefined performance endpoint, with 87.5% of patients achieving successful reperfusion (mTICI 2b-3) following treatment. Even more notably, 70.4% of patients achieved near-complete or complete reperfusion (mTICI 2c-3), an outcome associated with improved neurological recovery and fewer complications. Additional performance metrics further strengthened the clinical evidence, including a 64.8% first-pass successful reperfusion rate, a median time-to-revascularization of only 20 minutes, and an impressive 83% complete clot ingestion rate, demonstrating the device’s ability to efficiently remove thrombus during mechanical thrombectomy procedures. These results position THUNDERBOLT among the most promising innovations in neurovascular stroke intervention.
Advanced CAVT Technology Delivers Strong Safety Profile
Beyond procedural success, THUNDERBOLT™ demonstrated an encouraging safety profile. The incidence of device- or procedure-related serious adverse events was only 2.8%, while symptomatic intracranial hemorrhage (sICH) occurred in just 0.9% of patients. Furthermore, the 90-day all-cause mortality rate was 11.7%, comparing favorably with published outcomes from other thrombectomy technologies. THUNDERBOLT utilizes Computer Assisted Vacuum Thrombectomy (CAVT™) technology, which introduces modulated aspiration capable of detecting, fatiguing, and completely ingesting clots directly at the site of vessel occlusion. Unlike traditional aspiration systems, this intelligent aspiration approach is designed to maximize clot removal efficiency while minimizing procedural complexity. Investigators noted that consistent and complete clot removal may contribute to improved patient recovery and enhanced procedural confidence for physicians treating complex stroke cases.
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FDA Clearance Strengthens Penumbra’s Stroke Portfolio
The positive THUNDER study results come shortly after THUNDERBOLT™ received U.S. FDA clearance and CE Mark, further expanding Penumbra’s neurovascular thrombectomy portfolio. As the global leader in thrombectomy technologies, Penumbra continues to develop innovative solutions for ischemic stroke, pulmonary embolism, acute limb ischemia, and other thromboembolic conditions. Acute ischemic stroke accounts for approximately 87% of all strokes worldwide, with 20% to 42% resulting from emergent large vessel occlusions, making rapid restoration of blood flow critical for reducing disability and improving survival. By combining advanced CAVT technology, rapid clot extraction, and strong clinical outcomes, THUNDERBOLT™ represents an important advancement in stroke care. The study provides robust clinical evidence supporting the system’s role in delivering fast, effective, and safe revascularization, potentially establishing a new standard for treating patients with severe ischemic stroke while expanding physician treatment options in neurointerventional practice.
Source: Penumbra Press release
