Penumbra has announced it has received US Food and Drug Administration (FDA) clearance for Thunderbolt, expanding its computer-assisted vacuum thrombectomy (CAVT) technology into the world of acute ischaemic stroke.
“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,” said Donald Frei (Swedish Medical Center, Denver, USA). “What sets Thunderbolt apart is the innovative design, which minimises catheter manipulation and promotes safe, complete clot capture—quickly restoring blood flow to the brain and giving patients the best chance at recovery.”
Powered by the Penumbra Engine, Thunderbolt introduces modulated aspiration to Penumbra’s neurothrombectomy portfolio, offering advanced CAVT technology designed to detect, fatigue and completely ingest clot at the site of the occlusion.
“Modulated aspiration may facilitate more consistent and complete clot removal when used in conjunction with standard aspiration thrombectomy catheters,” commented David Fiorella (Stony Brook University Hospital, Stony Brook, USA). “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.”
Penumbra notes in a press release that, as the only CAVT device available for stroke treatment in the USA, Thunderbolt represents a first-of-its-kind advancement in acute ischaemic stroke care.
“Penumbra was founded to redefine stroke care, and Thunderbolt delivers on that promise,” added Shruthi Narayan, president of Penumbra. “We are uniquely positioned as the only company offering CAVT technology across both vascular and neurovascular conditions, redefining blood clot care from head to toe. 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.”
Thunderbolt will be prepackaged with one of Penumbra’s market-leading catheters—Red 62, Red 68, Red 72 silver label, or Red 72 silver label with Sendit technology—according to the company.
