Spectrumedics Sonico-CX Coronary Intravascular Lithotripsy System Receives CE Mark Approval

January 6, 2026—Spectrumedics Medical announced that its Sonico-CX intravascular lithotripsy (IVL) system has obtained CE Mark certification under the European Union Medical Device Regulation (EU MDR). The system is composed of the Sonico-CX coronary IVL catheter and IVL generator.

The EU MDR milestone enables Spectrumedics to advance its planned commercial launch in Europe and the Middle East. The certification follows the initiation of commercialization across Latin America and Asia Pacific, noted the company.

According to Spectrumedics, the Sonico-CX system treats calcified coronary lesions by using acoustic pressure waves to modify both superficial and deep calcified plaques safely, thereby enhancing vessel compliance and facilitating optimal stent implantation. The system features 360° of circumferential energy delivery—up to 120 pulses per catheter; a low crossing profile; and a range of seven balloon sizes from 2.5 to 4.0 mm, stated the company.