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 comprises the Sonico-CX Coronary Intravascular Lithotripsy Catheter and the Intravascular Lithotripsy Generator.
The CE Mark was issued by the internationally recognised 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 the successful initiation of commercialisation across Latin America and the 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."
The Sonico-CX system treats calcified coronary lesions by utilising acoustic pressure waves to modify both superficial and deep calcified plaques safely, thereby enhancing vessel compliance and facilitating optimal stent implantation. It features 360° of circumferential energy delivery, up to 120 pulses per catheter, a low crossing profile and a range of 7 balloon sizes (2.5 to 4.0 mm). These design advancements aim to improve vessel compliance and procedural outcomes. As a minimally invasive and user-friendly technology, IVL is characterised by a short learning curve and broad applicability, which reduces procedure-related complications and the need for subsequent treatments—thus improving patient outcomes.
