Penumbra’s CAVT Technology Cleared for DVT Indication

October 20, 2026—Penumbra, Inc. announced that the FDA has granted clearance for the treatment of deep vein thrombosis (DVT) to the company’s Lightning computer-assisted vacuum thrombectomy (CAVT) technology.

According to the company, this indication is supported by results from the BOLT-DVT investigational device exemption (IDE) trial, which demonstrated the safety and efficacy of CAVT in treating DVT. The BOLT-DVT Coprincipal Investigators are vascular surgeon Patrick E. Muck, MD, and interventional radiologist Kush R. Desai, MD.

Dr. Muck recently presented the findings from BOLT-DVT at VIVA 2026, the Vascular Interventional Advances conference.

As summarized in Penumbra’s press releasee, 98% of patients in BOLT-DVT 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%. Additionally, there was a low rethrombosis rate and improvements in patient-reported and clinician-assessed outcomes, including reduced pain and symptoms, and improved quality of life.

“The standard treatment for DVT has been anticoagulation and there has not been a meaningful change in standard of care for decades,” commented Dr. Muck in Penumbra’s press release. “Anticoagulation primarily prevents clot progression and does little to remove the existing clot. The BOLT-DVT trial showed that CAVT delivered rapid clot removal, durable patient-reported pain relief and a low rate of rethrombosis. The data resulted in the first cleared indication for the treatment of DVT amongst mechanical thrombectomy devices, underscoring the potential of CAVT to advance the treatment algorithm of DVT and improve patient outcomes.”

BOLT-DVT Coprincipal Investigator Kush R. Desai, MD, from Northwestern Medicine in Chicago, Illinois, added, “In the BOLT-DVT trial, treatment with CAVT successfully restored lower extremity deep venous flow in a single session. Perhaps more significant, patients felt immediate pain relief and by 30 days, there was significant improvement in venous stasis symptoms that included lower extremity pain and swelling. These findings provide clinicians with important evidence supporting the benefits of advanced intervention, such as CAVT, as a first-line treatment for acute iliofemoral DVT.”