Penumbra announced that the US Food and Drug Administration (FDA) has granted clearance for its Lightning computer assisted vacuum thrombectomy (CAVT) technology to treat deep vein thrombosis (DVT).
The indication is supported by BOLT-DVT, a prospective, multicentre Investigational Device Exemption trial evaluating the technology in patients with acute iliofemoral DVT.
The study enrolled 229 patients across 39 US sites. Its primary effectiveness endpoint assessed complete or near-complete clot reduction in the target venous segment, while the primary safety endpoint measured major adverse events within 48 hours.