American medical device company Penumbra has received clearance from the US Food and Drug Administration (FDA) for THUNDERBOLT, expanding its computer-assisted vacuum thrombectomy (CAVT) technology for the treatment of acute ischemic stroke.
The newly approved technology is powered by the Penumbra ENGINE and introduces modulated aspiration into the company’s neuro thrombectomy portfolio. THUNDERBOLT is designed to detect, fatigue and completely ingest blood clots directly at the site of vessel blockage, helping restore blood flow to the brain more efficiently.
Acute ischemic stroke occurs when a clot blocks blood supply to the brain and requires rapid treatment to reduce the risk of long-term disability or death.
Donald Frei, neurointerventional radiologist at Swedish Medical Center in Denver, said timely clot removal remains critical in stroke care.
“Stroke is the second leading cause of death worldwide and with stroke, timing is critical. If the blood clot isn’t removed and the artery reopened quickly, patients can face severe disability or even death,” he said.
Frei added that THUNDERBOLT’s innovative design minimizes catheter manipulation and promotes safe and complete clot capture to quickly restore blood flow to the brain, giving patients the best chance at recovery.
David Fiorella, director of the Cerebrovascular Center at Stony Brook University Hospital, said the modulated aspiration may improve consistency and complete clot removal when used alongside standard aspiration thrombectomy catheters.
“Our early experience with THUNDERBOLT within the context of the trial, suggests that this technology will meaningfully change how we approach stroke treatment, and could substantively improve outcomes in patients with emergent large vessel occlusion,” he added.
Penumbra said THUNDERBOLT is currently the only CAVT device available in the US for stroke treatment.
Shruthi Narayan, president of Penumbra, said the approval reflects the company’s long-term focus on transforming stroke care and extends its clot-removal technology across both vascular and neurovascular conditions.
“Penumbra has delivered more than two decades of innovation, and THUNDERBOLT marks the beginning of a new era in stroke management, one that we believe will fundamentally change outcomes for patients,” she said.
Penumbra said THUNDERBOLT will be pre-packaged with one of its market-leading catheters – RED 62, RED 68, RED 72 SILVER LABEL or RED 72 SILVER LABEL with SENDit technology.
