#Singapore #Spectrumedics #Sonico-CX #lithotripsy

Spectrumedics Receives CE Mark for Sonico-CX Intravascular Lithotripsy System

Introduction
On January 6, 2026, Spectrumedics Medical, a burgeoning player in the cardiovascular medical device sector, announced a significant milestone with the receipt of CE marking for its groundbreaking Sonico-CX intravascular lithotripsy system. This notable achievement showcases the company's commitment to enhancing treatment options for patients suffering from calcified coronary lesions, thereby revolutionizing vascular care.

What is the Sonico-CX System?
The Sonico-CX system comprises a dedicated coronary intravascular lithotripsy catheter and an accompanying generator. This innovative technology employs acoustic pressure waves to safely modify both superficial and deep calcified plaques within the coronary arteries. By using this unique procedure, the system enhances vessel elasticity, thereby facilitating optimal stent implantation.

The CE mark, awarded by BSI, a globally recognized notified body, verifies that the Sonico-CX system adheres to the stringent safety, performance, and quality requirements set forth by the European Union. This regulatory accomplishment not only signifies a leap forward in spectrum medical’s global expansion strategy but also solidifies its entry into the European and Middle Eastern markets after successful launches in Latin America and the Asia-Pacific region.

Future Developments and Goals
Looking ahead, Spectrumedics aims to broaden its portfolio of intravascular lithotripsy solutions. The company is currently focusing on developing an advanced forward-gear intravascular lithotripsy catheter specifically designed for challenging lesions. They also plan to extend their applications beyond coronary lesions to include peripheral vascular calcifications and valve procedures. This ambitious goal is part of Spectrumedics' overarching vision to promote the global adoption of advanced and reliable interventional solutions.

In a statement, Dr. Elynn Phang, founder and CEO of Spectrumedics, emphasized the significance of this achievement. “This success marks a critical milestone in our mission to broaden global access to advanced intravascular lithotripsy treatment. We look forward to collaborating with more physicians to offer quicker, safer, and more effective treatments for patients suffering from complex calcifications worldwide.”

Technical Specifications and Benefits
The Sonico-CX system is engineered to perform with remarkable efficacy. It provides a 360-degree energy delivery of up to 120 impulses per catheter. The low-profile crossing feature and availability in seven balloon sizes, ranging from 2.5 mm to 4.0 mm, significantly enhance procedural outcomes. By ameliorating vessel elasticity and reducing procedural complications, the system also mitigates the need for subsequent treatments, thus improving patient outcomes.

Furthermore, the non-invasive nature of intravascular lithotripsy is characterized by a short learning curve and extensive applicability, making it a highly user-friendly solution for healthcare professionals. This technology promotes an overall enhancement in procedural success rates while minimizing patient risk, showcasing its valuable role in modern cardiovascular therapies.

About Spectrumedics Medical
Spectrumedics is an international cardiovascular medical device company committed to advancing intravascular lithotripsy therapies to transform the treatment landscape for calcified vascular diseases. Through its proprietary technologies, the company aspires to redefine interventional care with safer, more effective, and accessible solutions to tackle one of the most complex and rapidly growing challenges in cardiovascular therapy.

Conclusion
With the CE mark now in hand, Spectrumedics is poised to make waves within the healthcare industry. The Sonico-CX system is not just a breakthrough in technology but also a beacon of hope for patients facing the daunting challenges posed by calcified coronary lesions. As they prepare for commercial launches in Europe and the Middle East, the future of cardiovascular treatment is bright with innovation and dedication driving the field forward.