BOLT-DVT Evaluates CAVT With Penumbra’s Indigo Aspiration System

October 16, 2026—A study of computer-assisted vacuum thrombectomy (CAVT) met its predefined primary effectiveness and safety endpoints for the treatment of patients with deep vein thrombosis (DVT). The prospective, multicenter BOLT-DVT study is evaluating CAVT using Penumbra’s Indigo aspiration system.

Patrick E. Muck, MD, presented the findings at VIVA 2026, the Vascular Interventional Advances conference.

According to the VIVA summary of the presentation, BOLT is an investigational device exemption study evaluating CAVT as a first-line treatment for acute iliofemoral DVT. The study enrolled 229 patients across 39 United States sites (mean age, 58.1 years; 62% female).

In the study, complete or near-complete (≥ 75%) thrombus reduction in the target venous segment was achieved in 98% of evaluable patients (198/202; P < .001), meeting the primary effectiveness endpoint.

VIVA further reported that the primary safety endpoint was met, with a 48-hour composite major adverse event (MAE) rate of 3.1% (7/229; P < .001). No device-related deaths or serious device-related adverse events were reported. Within 48 hours, major bleeding occurred in 1.3% of patients, symptomatic pulmonary embolism in 0.9%, and rethrombosis in 1.3%. The median thrombus reduction was 100%.

Additionally, procedural findings showed a device time of 18.0 minutes, with 99.1% of cases completed in a single session.

At 30 days, the composite MAE rate was 7.6%, and rethrombosis occurred in 3.9% of patients. Villalta scores improved from 11.0 at baseline to 1.0 at 30 days (P < .001).

Longer-term outcomes remain under evaluation, with follow-up planned through 2 years, advised the summary from VIVA.