Penumbra's CAVT Technology Receives FDA Clearance For The Treatment Of Deep Vein Thrombosis (DVT)

Penumbra's CAVT Technology Receives FDA Clearance For The Treatment Of Deep Vein Thrombosis (DVT)

BOLT-DVT, a recent prospective, multicenter Investigational Device Exemption (IDE) trial, demonstrated first-line use of computer assisted vacuum thrombectomy (CAVT) for DVT is safe and effective <p>The post Penumbra’s CAVT Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT) first appeared on Medical Device News Magazine.</p>

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…

Penumbra receives US FDA clearance for Lightning CAVT technology for the treatment of DVT

Penumbra has announced that the US Food and Drug Administration (FDA) has granted clearance for the treatment of deep vein thrombosis (DVT) to its Lightning computer assisted vacuum thrombectomy (CAVT) technology. The indication is supported by results from the BOLT-DVT investigational device exemption (IDE) trial. BOLT-DVT was a prospective, multicentre IDE trial that demonstrated first-line […]

98% of patients had all or nearly all of their clot removed in a trial. FDA cleared the device to treat deep-vein clots.

BOLT-DVT also reported a 3.1% major adverse event rate within 48 hours and a 3.9% re-thrombosis rate within 30 days among trial patients.