FDA clears Penumbra’s Lightning CAVT system for deep‑vein thrombosis treatment
The U.S. Food and Drug Administration granted clearance for Penumbra Inc.’s Lightning computer‑assisted vacuum thrombectomy (CAVT) technology to treat deep‑vein thrombosis (DVT). The decision is based on the BOLT‑DVT trial, which showed 98% of patients achieved complete or near‑complete clot removal with rapid procedure times and low complication rates. No device‑related deaths or serious adverse events were reported, and patients experienced immediate pain relief and improved quality of life. Penumbra’s Lightning Flash algorithms control aspiration to detect and extract clots safely.
Why it matters
The clearance enables Penumbra to market the CAVT system for DVT in the United States, potentially expanding its addressable market and driving future sales. The trial’s strong safety and efficacy results may encourage adoption by vascular specialists, supporting revenue growth.
Key facts
- 1The FDA granted clearance for Penumbra’s Lightning CAVT technology to treat deep‑vein thrombosis. stocktitan.net
- 2In the BOLT‑DVT trial, 98% of patients had complete or near‑complete thrombus removal. investing.com
- 3The trial reported a 48‑hour major adverse event rate of 3.1%. investing.com
- 4Re‑thrombosis occurred in 3.9% of patients within 30 days. stocktitan.net
- 530‑day patency rates ranged from 88.8% to 96.3% across treated vessels. stocktitan.net
- 684.3% of patients showed no post‑thrombotic syndrome symptoms at 30 days. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.