Penumbra announced today that it has secured a CE mark in Europe for Thunderbolt, which the company says further lays the groundwork for computer-assisted vacuum thrombectomy (CAVT) technology being launched to address acute ischaemic stroke globally. Penumbra also received US Food and Drug Administration (FDA) clearance for Thunderbolt 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 Vincent Costalat (University Hospital of Montpellier, 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 the company’s neurothrombectomy 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,” commented Shruthi Narayan, the company’s president. “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.”
As the only CAVT device available for stroke treatment in Europe—as well as the USA—Thunderbolt represents a “first-of-its-kind” advancement in acute ischaemic stroke care, according to Penumbra.
“Thunderbolt has the potential to shorten procedure times, improving patient safety, delivering better outcomes and streamlining care for the physicians who treat them,” stated Joan Kristensen, head of the Europe, Middle East and Africa (EMEA) region for Penumbra. “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.”
Penumbra says Thunderbolt will be prepackaged with one of its market-leading catheters—Red 62, Red 68, Red 72 Silver Label, or Red 72 Silver Label with Sendit technology.
