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Penumbra's CAVT Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT)

PEN
  • The U.S. FDA granted clearance to Penumbra, Inc. for the Lightning™ computer assisted vacuum thrombectomy (CAVT™) technology to treat deep vein thrombosis (DVT).
  • The clearance is supported by positive results from the BOLT-DVT prospective, multicenter Investigational Device Exemption (IDE) trial demonstrating safety & efficacy for first-line use.
  • The trial enrolled patients with iliofemoral DVT & showed 98% experienced complete or near-complete thrombus removal with a median device time of 18 minutes.
  • A low 48-hour major adverse event rate of 3.1% was recorded with no device-related deaths or serious device-related adverse events observed.
  • The trial reported a low re-thrombosis rate of 3.9% within 30 days & high 30-day patency rates ranging from 88.8% to 96.3% across treated vessels.
  • Patient-reported outcomes included immediate reduction in leg pain severity from a median of 5 to 0, with 84.3% of patients showing no post-thrombotic syndrome symptoms at 30 days.
  • Significant improvements in quality of life were noted with median VEINES-QOL scores rising from 49.3 at baseline to 84.2 at 30 days.
  • This indication represents the first cleared indication for a mechanical thrombectomy device specifically for the treatment of DVT.
  • Penumbra's CAVT portfolio utilizes Lightning Flash™ technology to facilitate clot removal via pressure- & flow-based aspiration control algorithms.