Spectrumedics Gains CE Mark for Coronary IVL System in Europe

Spectrumedics Medical has received CE mark approval for its Sonico-CX coronary intravascular lithotripsy (IVL) system under the EU Medical Device Regulation. The Singapore-based company’s system uses acoustic pressure waves to treat calcified coronary lesions. With the CE mark, Spectrumedics plans to focus on European commercialization, following prior approvals in Latin America and the Asia Pacific.

The IVL market is still emerging, with few competitors. Johnson & Johnson’s Shockwave and Elixir Medical are currently the only other companies with EU-approved coronary IVL systems. Shockwave, acquired by J&J in 2024, remains a major player, while Boston Scientific’s Bolt Medical and Abbott are pursuing IVL development in the U.S.

IVL offers a minimally invasive alternative to atherectomy for treating calcified lesions. Analysts forecast the global IVL market could exceed $2 billion by 2034, highlighting the growth potential as more companies enter this nascent space.

06-01-2026