FDA OKs Penumbra’s Thunderbolt Computer-Assisted Vacuum Thrombectomy for Stroke

Thrombectomy company Penumbra has received U.S. Food and Drug Administration (FDA) clearance for Thunderbolt, growing its computer-assisted vacuum thrombectomy (CAVT) technology to address acute ischemic stroke.

Thunderbolt is powered by the Penumbra Engine and introduces modulated aspiration to the company’s neuro thrombectomy portfolio. It now offers advanced CAVT technology engineered to detect, fatigue, and completely ingest clot at the occlusion site.

The company cited a recent analysis estimating that stoke mortality worldwide is projected to rise by 50% between 2020 to 2050. Someone suffers from a stroke every 40 seconds in the U.S., and one in every 21 dies from the condition.

As the only CAVT device available in the U.S. to treat stroke, Thunderbolt is a first-of-its-kind advancement in acute ischemic stroke care. It will be pre-packed with Penumbra’s catheters: Red 62, Red 68, Red 72 Silver Label, or Red 72 Silver Label with SENDit technology.

In January, the company rolled out its Lightning Flash 3.0 CAVT system, which includes upgrades to its venous thromboembolism (VTE) platform.

Comments from Penumbra and clinicians

Shruthi Narayan, president of Penumbra: “Penumbra was founded to redefine stroke care and THUNDERBOLT delivers on that promise. 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.”

Donald Frei, MD, neurointerventional radiologist at Swedish Medical Center (Denver, Colorado): “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. What sets THUNDERBOLT apart is the innovative design which minimizes catheter manipulation and promotes safe, complete clot capture—quickly restoring blood flow to the brain and giving patients the best chance at recovery.”

David Fiorella, MD, Ph.D., director of the Cerebrovascular Center, Stony Brook University Hospital: “Modulated aspiration may facilitate more consistent and complete clot removal when used in conjunction with 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.”