Spectrumedics Medical has secured CE Mark certification under the European Union Medical Device Regulation for its Sonico-CX Intravascular Lithotripsy (IVL) System.

Obtaining the CE Mark further strengthens the company’s global expansion strategy, following the start of commercialization across Latin America and Asia Pacific, and enables Spectrumedics to advance its planned commercial launch in Europe and the Middle East.

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.

“This achievement marks a significant step in Spectrumedics’ mission to broaden global access to advanced IVL therapy,” Spectrumedics Founder/CEO Dr. Elynn Phang stated. “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 IVL system comprises the Sonico-CX Coronary Intravascular Lithotripsy Catheter and the Intravascular Lithotripsy Generator. The Sonico-CX system treats calcified coronary lesions by utilizing acoustic pressure waves to modify both superficial and deep calcified plaques safely, thereby enhancing vessel compliance and facilitating optimal stent implantation. It features 360 degrees of circumferential energy delivery, up to 120 pulses per catheter, a low crossing profile and a range of seven balloon sizes (2.5 mm 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 characterized by a short learning curve and broad applicability, which reduces procedure-related complications and the need for subsequent treatments—thus improving patient outcomes.

Spectrumedics is a rapidly growing international cardiovascular medical device company dedicated to advancing Intravascular Lithotripsy (IVL) therapy to transform calcified vascular disease treatment. Through its proprietary technology platforms, the company aims to redefine interventional care by enabling safer, more effective, and more accessible solutions for one of the most complex and rapidly expanding challenges in cardiovascular therapy.