Penumbra's CAVT Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT)
Key Highlights
- ➤FDA cleared Penumbra’s CAVT technology for treating deep vein thrombosis.
- ➤BOLT-DVT achieved 98% complete or near-complete thrombus removal.
- ➤Median device time was 18 minutes, with a 3.1% 48-hour major adverse event rate.
- ➤30-day re-thrombosis rate was 3.9%, while vessel patency reached 88.8%-96.3%.
- ➤Pending Boston Scientific acquisition remains subject to regulatory approvals and other risks.
Expert Statements
Patrick Muck, M.D., RVT, FACS; co-principal investigator of BOLT-DVT and vascular surgeon at TriHealth
“The standard treatment for DVT has been anticoagulation and there has not been a meaningful change in standard of care for decades”
Patrick Muck, M.D., RVT, FACS; co-principal investigator of BOLT-DVT and vascular surgeon at TriHealth
“Anticoagulation primarily prevents clot progression and does little to remove the existing clot.”
Patrick Muck, M.D., RVT, FACS; co-principal investigator of BOLT-DVT and vascular surgeon at TriHealth
“The BOLT-DVT trial showed that CAVT delivered rapid clot removal, durable patient-reported pain relief and a low rate of re-thrombosis.”
Patrick Muck, M.D., RVT, FACS; co-principal investigator of BOLT-DVT and vascular surgeon at TriHealth
“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.”
Kush R. Desai, M.D., FSIR; co-principal investigator of BOLT-DVT and interventional radiologist at Northwestern Medicine
“In the BOLT-DVT trial, treatment with CAVT successfully restored lower extremity deep venous flow in a single session,”
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.”
Kush R. Desai, M.D., FSIR; co-principal investigator of BOLT-DVT and interventional radiologist at Northwestern Medicine
“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.”
James F. Benenati, M.D., FSIR; chief medical officer at Penumbra
“DVT remains an underestimated health issue that can lead to serious, potentially life-threatening complications”
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 Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT) PR Newswire
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
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