Penumbra Wins FDA Clearance For Lightning CAVT Technology To Treat Deep Vein Thrombosis, Backed By BOLT-DVT Trial Results

Benzinga · 1d ago

BOLT-DVT, a recent prospective, multicenter Investigational Device Exemption (IDE) trial, demonstrated first-line use of computer assisted vacuum thrombectomy (CAVT) for DVT is safe and effective

ALAMEDA, Calif., Oct. 20, 2026 /PRNewswire/ -- Penumbra, Inc. (NYSE:PEN), the world's leading thrombectomy company, announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the treatment of deep vein thrombosis (DVT) to the company's Lightning™ computer assisted vacuum thrombectomy (CAVT™) technology. This indication is supported by positive results from the BOLT-DVT Investigational Device Exemption (IDE) trial, which demonstrated the safety and efficacy of CAVT in treating DVT.