FDA clears new computer-assisted device for removing clots in stroke patients
Penumbra, a California-based medtech company known for its vascular technologies, has received U.S. Food and Drug Administration (FDA) clearance for a new computer-assisted vacuum thrombectomy (CAVT) device designed to treat acute ischemic stroke.
According to Penumbra, Thunderbolt represents the first CAVT device approved in the United States for the treatment of stroke. It is powered by Penumbra’s Engine technology and uses modulated aspiration to “detect, fatigue and completely ingest” blood clots at the site of occlusion. Thunderbolt will be sent to customers prepackaged with one of the company’s catheters.
“Penumbra was founded to redefine stroke care and Thunderbolt delivers on that promise,” Shruthi Narayan, president of Penumbra, said in a statement. “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.”
“Modulated aspiration may facilitate more consistent and complete clot removal when used in conjunction with standard aspiration thrombectomy catheters,” added David Fiorella, MD, PhD, director of the Cerebrovascular Center at Stony Brook University Hospital. “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.”
FDA clearance follows Boston Scientific acquisition
Back in January, Boston Scientific agreed to acquire Penumbra for approximately $14.5 billion in a transaction that values the company at $374 per share. That acquisition is expected to close in the months ahead.
“Penumbra is a well-established company with an experienced, high-performing team and this acquisition offers Boston Scientific an opportunity to enter new, fast-growing segments within the vascular space,” Mike Mahoney, chairman and CEO of Boston Scientific, said at the time.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.