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Penumbra has received FDA clearance for its Lightning computer assisted vacuum thrombectomy (CAVT) technology for the treatment of deep vein thrombosis (DVT). The indication is supported by BOLT-DVT, a prospective, multicenter IDE trial in patients with iliofemoral DVT.
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In the trial, 98% of patients achieved 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%. Re-thrombosis within 30 days was 3.9%, and 30-day patency ranged from 88.8% to 96.3% across treated vessels. There were no device-related deaths or serious device-related adverse events. Median leg pain fell from 5 at baseline to 0 immediately after the procedure and at 30 days, and median VEINES-QOL scores improved from 49.3 to 84.2.
The clearance targets a care pathway that has centered on anticoagulation, which prevents clot progression but does not remove the existing clot. Co-principal investigator Dr. Patrick Muck said there has been “no meaningful change in standard of care for decades,” and described the clearance as the first for DVT among mechanical thrombectomy devices. An estimated 900,000 venous thromboembolism cases occur annually in the U.S.
For Penumbra, the indication widens the use of its CAVT portfolio in venous disease. For the broader MedTech space, it arrives while Boston Scientific’s $14.5 billion acquisition of Penumbra, announced in January, awaits closing.
