FDA Clears Computer Assisted Vacuum Thrombectomy for Deep Vein Thrombosis

The FDA has cleared Penumbra’s Lightning computer assisted vacuum thrombectomy (CAVT) technology for the treatment of deep vein thrombosis (DVT), the company announced. The indication is supported by results from the BOLT-DVT investigational device exemption (IDE) trial.

BOLT-DVT was a prospective, multicenter IDE trial that enrolled patients with iliofemoral DVT. According to the company, 98% of patients had complete or near-complete thrombus removal, with a median device time of 18 minutes and a 48-hour major adverse event rate of 3.1%. No device-related deaths or serious device-related adverse events were observed. The re-thrombosis rate was 3.9% within 30 days, and 30-day patency rates ranged from 88.8% to 96.3% across treated vessels.

At 30 days, 84.3% of patients had no post-thrombotic syndrome symptoms (Villalta score, 0-4). Median leg pain severity decreased from 5 at baseline to 0 immediately after the procedure and remained 0 at 30 days, and median VEINES-QOL scores improved from 49.3 to 84.2.

Co-principal investigator Patrick Muck, MD, a vascular surgeon at TriHealth in Cincinnati, Ohio, said the trial data resulted in the first cleared indication for DVT treatment among mechanical thrombectomy devices. He noted that anticoagulation, the standard DVT treatment, primarily prevents clot progression and does little to remove existing clot.

The company’s announcement did not report the number of patients enrolled, outcomes beyond 30 days, or a comparison group.

Penumbra’s CAVT portfolio incorporates Lightning Flash technology, which uses pressure- and flow-based aspiration control algorithms to detect clot and blood flow during thrombectomy, according to the company.

Source: Penumbra, Inc. Penumbra’s CAVT technology receives FDA clearance for the treatment of deep vein thrombosis (DVT). Press release. Penumbra, Inc; October 20, 2026. Accessed October 20, 2026.