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
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
ALAMEDA, Calif. -- Penumbra, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the treatment of deep vein thrombosis (DVT) to the company's Lightning™ computer assisted vacuum thrombectomy (CAVT™) technology. This indication is supported by positive results from the BOLT-DVT Investigational Device Exemption (IDE) trial, which demonstrated the safety and efficacy of CAVT in treating DVT.
"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., RVT, FACS, co-principal investigator of BOLT-DVT and vascular surgeon at TriHealth in Cincinnati, Ohio. "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 re-thrombosis. 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.”
In the U.S., an estimated 900,000 cases of venous thromboembolism, which includes DVT and pulmonary embolism (PE), occur annually.[i] DVT can be a serious health condition because blood clots in the veins can break loose and travel through the bloodstream, potentially causing a PE, which can be a life-threatening medical emergency. BOLT-DVT enrolled patients with iliofemoral DVT, building on the historical precedent set by the ATTRACT randomized controlled trial but with modern technology. In BOLT-DVT, 98% of patients experienced complete or near-complete thrombus removal with a median device time of just 18 minutes and a low 48-hour major adverse event rate of 3.1%. These strong procedural outcomes were accompanied by a low re-thrombosis rate and improvements in patient-reported and clinician-assessed outcomes, including reduced pain and symptoms, and improved quality of life.
In the BOLT-DVT trial, treatment with CAVT successfully restored lower extremity deep venous flow in a single session," said Kush R. Desai, M.D., FSIR, co-principal investigator of BOLT-DVT and interventional radiologist at Northwestern Medicine. "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.”
Additional findings from the trial included:
- No device-related deaths or serious device-related adverse events were observed
- Low re-thrombosis rate of 3.9% within 30 days
- High 30-day patency rates of 88.8%-96.3% across treated vessels
- 84.3% of patients with no PTS symptoms (Villalta 0-4, no PTS) at 30 days
- Median leg pain severity decreased from 5 (moderate to severe) at baseline to 0 (no pain) immediately post-procedure and 0 (no pain) at 30 days
- Significant improvements in patient-reported overall quality of life at 30 days, with median VEINES-QOL scores improving from 49.3 to 84.2
"DVT remains an underestimated health issue that can lead to serious, potentially life-threatening complications," said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. "This cleared treatment indication and the BOLT-DVT findings support advanced intervention for DVT and highlight the potential impact of CAVT on patient symptoms, quality of life and long-term clinical outcomes."
Penumbra's CAVT portfolio incorporates Lightning Flash™ technology, which utilizes pressure- and flow-based aspiration control algorithms during thrombectomy procedures to detect blood clot and blood flow. The portfolio is designed to facilitate clot removal with speed, safety and simplicity, allowing physicians to better navigate the body's complex anatomy and deliver high power aspiration for clot removal.
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