Penumbra’s THUNDERBOLT Receives FDA Clearance - Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke
THUNDERBOLT is the first CAVT platform to deliver modulated aspiration for acute ischemic stroke — enabling faster, more complete clot removal
THUNDERBOLT is the first CAVT platform to deliver modulated aspiration for acute ischemic stroke — enabling faster, more complete clot removal
ALAMEDA, Calif. – Penumbra, Inc. has received U.S. Food and Drug Administration (FDA) clearance for THUNDERBOLT™, expanding its computer assisted vacuum thrombectomy (CAVT™) technology to address acute ischemic stroke.
“Stroke is the second leading cause of death worldwide and with stroke, timing is critical. If the blood clot isn’t removed and the artery reopened quickly, patients can face severe disability or even death,” said Donald Frei, M.D., neurointerventional radiologist at Swedish Medical Center, Denver, CO. “What sets THUNDERBOLT apart is the innovative design which minimizes catheter manipulation and promotes safe, complete clot capture - quickly restoring blood flow to the brain and giving patients the best chance at recovery.”
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.
“Modulated aspiration may facilitate more consistent and complete clot removal when used in conjunction with standard aspiration thrombectomy catheters," said 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.”
A recent analysis estimates that stroke mortality worldwide is projected to increase by 50% between 2020 to 2050. In the U.S., someone suffers from a stroke every 40 seconds, and 1 in every 21 people dies from the condition. As the only CAVT device available for stroke treatment in the U.S., THUNDERBOLT represents a first-of-its-kind advancement in acute ischemic stroke care.
“Penumbra was founded to redefine stroke care and THUNDERBOLT delivers on that promise,” said Shruthi Narayan, president of Penumbra. “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."
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.
About Penumbra
Penumbra, Inc., the world’s leading thrombectomy company, is focused on developing the most innovative technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety, and simplicity. By pioneering these innovations, we support healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life. For more information, visit www.penumbrainc.com and connect on Instagram, LinkedIn and X.
Important Safety Information
Additional information about Penumbra’s products can be located on Penumbra’s website at https://www.penumbrainc.com/providers. Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Please visit www.peninc.info/risk for the complete IFU Summary Statements.
The clinical results presented herein are for informational purposes only and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.
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