The CE Mark was issued by the internationally recognized notified body BSI, confirming that the Sonico-CX IVL system meets the EU’s stringent requirements for safety, performance and quality. This important regulatory milestone further strengthens Spectrumedics’ global expansion strategy, following successful initiation of commercialization across Latin America and Asia Pacific, and enables Spectrumedics to advance its planned commercial launch in Europe and the Middle East.

Looking ahead, Spectrumedics is advancing its IVL pipeline, including a forward-firing IVL catheter designed for tight and uncrossable lesions. The company also plans to extend IVL from coronary indications to peripheral vascular calcification and valvular applications, to support the global adoption of advanced, safe interventional solutions.

Dr. Elynn Phang, Founder and CEO of Spectrumedics commented:

“This achievement marks a significant step in Spectrumedics’ mission to broaden global access to advanced IVL therapy. We look forward to collaborating with more physicians to deliver faster, safer, and more effective treatment to patients with complex calcification worldwide.”