Penumbra's CAVT Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT)
Penumbra received FDA clearance for its Lightning CAVT technology to treat deep vein thrombosis — the first cleared DVT indication among mechanical thrombectomy devices. The clearance is supported by the BOLT-DVT IDE trial, which showed 98% complete or near-complete clot removal, an 18-minute median device time, a 3.1% 48-hour major adverse event rate, and a 3.9% 30-day re-thrombosis rate. The indication opens an estimated 900,000 annual U.S.
Key figures
- Drug Name
- Lightning computer assisted vacuum thrombectomy (CAVT)
- Phase Of Trial
- IDE trial (BOLT-DVT)
- Patency 30d
- 88.8%-96.3%
- No pts symptoms 30d
- 84.3%
- Thrombus removal rate
- 98% complete or near-complete
- Us vte cases annually
- 900000
- Re thrombosis rate 30d
- 3.9%
- Veines qol improvement
- 49.3 to 84.2
- Median device time minutes
- 18
- Major adverse event rate 48h
- 3.1%
AI analysis
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