Penumbra, Inc. (NYSE: PEN), the world’s leading thrombectomy company, announced it has secured CE Mark in Europe for THUNDERBOLT™, further laying the groundwork for launching computer assisted vacuum thrombectomy (CAVT™) technology to address acute ischemic stroke globally. The company received U.S. Food and Drug Administration clearance last week.
“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.”
Powered by the Penumbra ENGINE™, THUNDERBOLT introduces modulated aspiration to Penumbra’s neuro thrombectomy portfolio, offering advanced CAVT technology designed to detect, fatigue, and completely ingest clot at the site of the occlusion.
“THUNDERBOLT is a culmination of two decades of research and innovation at Penumbra,” said Shruthi Narayan, president of 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.”
A recent analysis estimates that stroke mortality worldwide is projected to increase by 50% between 2020 to 2050i. As the only CAVT device available for stroke treatment in Europe, as well as the U.S., THUNDERBOLT represents a first-of-its-kind advancement in acute ischemic stroke care.
“THUNDERBOLT has the potential to shorten procedure times — improving patient safety, delivering better outcomes and streamlining care for the physicians who treat them,” said Joan Kristensen, head of the Europe, Middle East and Africa region for Penumbra, Inc. “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.”
THUNDERBOLT will be pre-packaged with one of Penumbra’s market-leading catheters – RED™ 62, RED 68, RED 72 SILVER LABEL or RED 72 SILVER LABEL with SENDit™ technology.