Penumbra’s Thunderbolt Computer-Assisted Vacuum Thrombectomy Earns CE Mark

Penumbra has earned CE mark clearance for its Thunderbolt computer-assisted vacuum thrombectomy (CAVT) technology for acute ischemic stroke.

Thunderbolt introduces modulated aspiration to the company’s neuro thrombectomy portfolio. It offers advanced CAVT tech to detect, fatigue, and completely ingest clot at the occlusion site.

The company cited a recent analysis estimating that stroke mortality worldwide is projected to increase by 50% between 2020 and 2050. Thunderbolt is a first-of-its kind advancement in acute ischemic stroke care and the only CAVT device available for stroke treatment in Europe. The device earned U.S. Food and Drug Administration (FDA) clearance last week.

Thunderbolt will be pre-packaged with one of Penumbra’s catheters: Red 62, Red 68, Red 72 Silver Label, or Red 72 Silver Label with SENDit technology.

“Stroke is the second leading cause of death worldwide, and if a blood clot is not fully removed, there is an increased risk of serious complications, disability or death,” said Prof. Vincent Costalat, head of neuroradiology at Centre Hospitalier Universitaire, Montpellier, France. “I am really enthusiastic and eager to see what THUNDERBOLT will bring for patients. What I love in the system is that it brings intelligence to the vacuum.”

Comments from Penumbra executives

Shruthi Narayan, president: “THUNDERBOLT is a culmination of two decades of research and innovation at Penumbra. By introducing CAVT to the neurovascular field in Europe, we are ushering in a new era of stroke management that will have a significant impact on patient care. We are the only company to offer CAVT technology across both vascular and neurovascular care as we are committed to transforming how life-threatening clots are treated from head-to-toe worldwide.”

Joan Kristensen, head of the Europe, Middle East and Africa region: “THUNDERBOLT has the potential to shorten procedure times—improving patient safety, delivering better outcomes and streamlining care for the physicians who treat them. Bringing this technology to Europe is a significant milestone—and a reflection of Penumbra’s ongoing commitment to putting the most advanced stroke care tools in the hands of physicians across the region.”