Penumbra, Inc. (NYSE: PEN) said the U.S. Food and Drug Administration has cleared its Lightning computer assisted vacuum thrombectomy (CAVT) technology for the treatment of deep vein thrombosis (DVT), according to a company statement.

The clearance is supported by results from the BOLT-DVT Investigational Device Exemption trial, a prospective, multicenter study evaluating CAVT as a first-line treatment for acute iliofemoral DVT. In the trial, 98% of patients experienced 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%.

Additional trial findings included a 30-day re-thrombosis rate of 3.9%, 30-day patency rates of 88.8% to 96.3% across treated vessels, and 84.3% of patients showing no post-thrombotic syndrome symptoms at 30 days. Median leg pain scores fell from 5 at baseline to 0 immediately after the procedure and remained at 0 at 30 days. Patient-reported quality of life scores, measured by VEINES-QOL, improved from a median of 49.3 to 84.2 at 30 days. No device-related deaths or serious device-related adverse events were observed.

"The standard treatment for DVT has been anticoagulation and there has not been a meaningful change in standard of care for decades," said Patrick Muck, M.D., co-principal investigator of BOLT-DVT and vascular surgeon at TriHealth in Cincinnati, Ohio. "The data resulted in the first cleared indication for the treatment of DVT amongst mechanical thrombectomy devices."

Kush R. Desai, M.D., co-principal investigator and interventional radiologist at Northwestern Medicine, said treatment with CAVT restored lower extremity deep venous flow in a single session, with patients reporting immediate pain relief and significant improvement in venous stasis symptoms by 30 days.

An estimated 900,000 cases of venous thromboembolism occur annually in the U.S., according to the American Lung Association. Penumbra is based in Alameda, California.