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.

Complete or near-complete clot reduction was achieved in 198 of 202 patients assessed for effectiveness, representing 98%. The 48-hour major adverse event rate was 3.1%, or seven of 229 patients. No device-related deaths or serious device-related adverse events were observed.

Median device time was 18 minutes, and 99.1% of procedures were completed in a single session. At 30 days, the composite major adverse event rate was 7.6%, while re-thrombosis occurred in 3.9%.

Post-thrombotic symptoms also improved, with the reported Villalta Score declining from 11 at baseline to one at 30 days. Both predefined primary endpoints were met, and follow-up is continuing through two years.

“DVT remains an underestimated health issue that can lead to serious, potentially life-threatening complications,” said James F. Benenati, Chief Medical Officer at Penumbra.

Penumbra’s CAVT portfolio incorporates Lightning Flash technology, which uses pressure- and flow-based aspiration controls to identify clot and blood flow during thrombectomy.

The reported findings describe outcomes in the study population. Individual results may vary.