Dive Brief:
- Penumbra has received a CE mark for its Thunderbolt computer assisted vacuum thrombectomy device, the company said Monday.
- The certification, which came days after the Food and Drug Administration cleared the device, positions Penumbra to launch Thunderbolt in Europe for clot removal in stroke patients.
- Penumbra’s global expansion could benefit Boston Scientific, which agreed to buy the company for about $14.5 billion in January.
Dive Insight:
Thunderbolt uses modulated aspiration to reduce friction between the clot and the reperfusion catheter, accelerating the removal of clots and restoration of blood flow. Fast clearance of clots is important to the effective treatment of stroke patients, whose long-term outcomes are shaped by how long blood-vessel blockages stop oxygen from reaching brain cells.
The system is built on a CAVT algorithm that generates proprietary modulated aspiration. By alternating between a continuous vacuum aspiration pump and ambient pressure, the Thunderbolt tubing modulates the pressure delivered to the aspiration catheter. Penumbra completed enrollment in a trial of the technology in 2024.
Penumbra reported revenue of $1.4 billion last year, and the U.S. accounted for roughly 78% of Penumbra’s sales. The company grew U.S. sales by 21% year over year, compared with about 7% internationally. The potential for Boston Scientific to use its global infrastructure to grow sales of Penumbra’s devices internationally was part of the rationale for the pending deal.
“Boston Scientific brings broad capabilities, including supply chain experience, expertise and a significant global commercial footprint that, upon close, would enable access to Penumbra technologies around the world,” CEO Mike Mahoney said on a conference call to discuss the deal in January.
Evercore ISI analyst Vijay Kumar recently predicted Thunderbolt could generate about $100 million in incremental revenue for Boston Scientific over time.
