Penumbra announced that it has secured CE mark approval in Europe for its Thunderbolt Thrombectomy system for stroke treatment, a development that follows FDA clearance granted only days earlier. The approval covers the company’s computer-assisted vacuum thrombectomy (CAVT) technology, expanding access to the platform beyond the U.S. market. Designed for the treatment of acute ischemic stroke, the system uses modulated aspiration technology intended to address clot removal at the site of an occlusion.
The Thunderbolt platform broadens Penumbra’s existing CAVT portfolio and is engineered to detect, fatigue and completely ingest clot during procedures. According to the company, the technology represents an advancement in acute ischemic stroke care and is powered by its Engine platform. With the European authorization, Penumbra said the device becomes the first and only CAVT technology available for stroke treatment in both the U.S. and Europe. The Thunderbolt Thrombectomy system will be supplied pre-packaged with one of the company’s catheter options, including Red 62, Red 68, Red 72, Silver Label or Red 72 Silver Label with SENDit technology.
The Alameda, California-based company described the approval as a significant milestone for its neurovascular business. Penumbra noted that the technology builds on two decades of research and development focused on clot-treatment solutions. The company also stated that it remains the only provider offering CAVT technology across both vascular and neurovascular care applications.
Commenting on the approval, Shruthi Narayan, president of Penumbra, said: “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 EMEA for Penumbra, added: “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.”
