Spectrumedics Medical's Sonico-CX System Receives CE Certification, Marking a New Era in Calcified Lesion Treatment

Jan 17, 2026 08:02 CST Updated 08:02

Spectrumedics

Developer of Cardiovascular Minimally Invasive Interventional Therapy

Sonico-CX System Receives CE Certification, Global Expansion Advances Further

On January 6, 2026, Spectrumedics Medical announced that its Sonico-CX Intravascular Lithotripsy (IVL) System received certification under the European Union Medical Device Regulation (EU MDR) and obtained the CE mark. This certification, issued by the internationally renowned notified body BSI, confirms that the Sonico-CX system meets the EU’s stringent standards for safety, performance, and quality, establishing a core foundation for its entry into the European and global markets.

Prior to this, Spectrumedics had already launched commercialization in Latin America and the Asia-Pacific region, receiving positive market feedback. The implementation of the CE certification has further advanced its commercial launch in Europe and the Middle East, helping the company accelerate its global layout and expand its global market share.

About Spectrumedics: The Innovative Force in Minimally Invasive Interventions

Spectrumedics was founded in March 2019 as an innovative enterprise focused on the research and development of active minimally invasive interventional technologies for cardiac and pan-vascular applications. Its core objective is to address practical clinical pain points by overcoming various challenges in the treatment of cardiac and pan-vascular diseases through its self-developed innovative technology platform. The company operates entities such as Spectrumedics Medical Technology (Shanghai) Co., Ltd. and Spectrumedics Medical Technology (Suzhou) Co., Ltd., with a registered capital of nearly 20 million yuan. It completed its Series B financing in 2024, demonstrating solid financial strength and a robust R&D foundation.

As a leading enterprise in China-produced IVL technology, Spectrumedics has been deeply engaged in the field of intravascular shock wave therapy. Its core product, the "Shockwave Balloon," has obtained patent authorization and can be widely applied in the treatment of peripheral lower limb artery and coronary artery stenotic lesions. With a comprehensive R&D, quality, and regulatory compliance system, the company has achieved global deployment of its core products.In March 2024, the Sonico-CX system received NMPA approval for marketing; in November of the same year, it obtained registration approval in Ecuador, becoming the first domestically produced IVL product to receive overseas certification; this CE certification approval, further confirming that its products meet international first-class standards and possess global market competitiveness.

In terms of technology promotion and academic cooperation, Spectrumedics actively builds an international exchange platform, and in September 2025, it will jointly establish with the Cardiovascular Hospital Affiliated to Xiamen University."IVL Joint Training Base"Focusing on the standardization of IVL technology operations, clinical validation, and talent development, Spectrumedics has already conducted academic exchanges and clinical training in multiple countries along the "Belt and Road" route, promoting the standardized global application of the technology. The company is gradually evolving from a single product provider to a promoter of IVL technology and an exporter of clinical methodologies, helping to enhance the global accessibility of innovative medical devices produced in China.

Empowered by Innovative Design, Sonico-CX System Boasts Outstanding Technical Advantages

(1) High-efficiency and precise treatment components

The core of the Sonico-CX system consists of a coronary IVL catheter and an IVL generator, which work together to provide critical support for the treatment of calcified lesions.

IVL Catheter Enables 360-Degree Circumferential Energy Delivery, Allowing Energy to be Applied Uniformly to Calcified Plaques, Avoiding Treatment Blind Spots and Ensuring Comprehensive Treatment; With Up to 120 Pulses Per Single Catheter, It Guarantees the Continuity and Effectiveness of the Treatment, While Allowing Physicians to Flexibly Adjust According to the Lesion Condition.

The system is equipped with seven balloon sizes ranging from 2.5-4mm, which can precisely match coronary vessels of different diameters, meeting diverse treatment needs; the low-profile design enhances the catheter's ability to navigate through tortuous and narrow complex vascular environments, laying a hardware foundation for precise treatment.

(II) Unique Treatment Mechanism

The Sonico-CX system precisely modifies superficial and deep calcified plaques by generating acoustic pressure waves, improving vascular compliance without damaging normal vascular tissue, thereby creating favorable conditions for subsequent stent implantation.

Compared with traditional treatment methods, the Sonico-CX system offers significant advantages: conventional cutting balloons, scoring balloons, and other passive interventional devices are only suitable for mild to moderate calcified lesions; while rotational atherectomy can address severe calcification, it is complex to operate, has a steep learning curve, and is prone to complications such as vascular perforation. In contrast, the mechanism of shockwave therapy effectively overcomes these limitations.

As a minimally invasive and user-friendly technology, IVL has a short learning curve, can be quickly applied in clinical settings, and is suitable for various types of calcified lesions, including concentric, eccentric, focal, and diffuse. It enables precise lesion management, reduces damage to normal vascular tissue, thereby lowering the incidence of surgical complications and subsequent treatment needs, and improving patient outcomes and prognosis quality.

Deeply Cultivating the Field of Calcified Lesions, Leading a New Direction in Interventional Treatment

(1) Addressing the Challenge of Treating Calcified Lesions

Coronary artery calcification is a major challenge in percutaneous coronary intervention (PCI). With the aggravation of population aging and the increase in patients with metabolic diseases, the incidence of moderate to severe calcified lesions has significantly risen. Particularly, complex calcifications such as circumferential and deep calcifications reduce vascular compliance, greatly increase procedural difficulty, and limit procedural success rates and long-term patient prognosis.

Traditional treatment methods have obvious limitations: passive interventional devices such as cutting balloons can only address mild to moderate calcification; rotational atherectomy is complex to operate with a steep learning curve, making it difficult to popularize in grassroots hospitals, and it carries a higher risk of complications, posing numerous challenges for clinical treatment.

The advent of the Sonico-CX system marks a breakthrough in the treatment of calcified lesions. Its sonic pressure waves can penetrate the vascular intima to directly target deep calcifications, precisely fragmenting calcified plaques, restoring vascular elasticity and compliance. It effectively addresses the limitations of traditional methods in treating deep and complex calcifications, enhancing both the efficacy and safety of the treatment.

(II) Unlock New Possibilities in Multi-Field Applications

Spectrumedics Continues to Advance IVL Product Line Expansion, Currently Developing Forward-Emitting IVL Catheters for Tight and Uncrossable Lesions. This catheter adopts a "non-balloon, forward-emitting" design, capable of emitting shockwaves from the front end to fragment anterior calcified tissue, paving the way for subsequent device passage. At the TCT 2025 conference, Academician Ge Junbo introduced this type of catheter jointly developed by Spectrumedics and Zhongshan Hospital, presenting three clinical cases that confirmed its outstanding efficacy, high safety, and short learning curve in treating complex coronary artery diseases.

At the same time, the company plans to expand the application of IVL technology from coronary artery indications to peripheral vascular calcification and valvular applications. Current treatments for peripheral vascular calcification and valvular diseases have many shortcomings. The introduction of IVL technology is expected to bring revolutionary changes, providing more patients with new treatment options and improving their quality of life.

Spectrumedics is committed to providing a broader range of advanced interventional treatment solutions for patients worldwide through continuous innovation, driving technological advancements in the field of vascular disease treatment and benefiting more patients.

Industry Outlook: Driving Global Access to Calcification Treatment through Innovation

Spectrumedics Founder and CEO Elynn Phang stated, "This achievement marks an important step in Spectrumedics' mission to expand global access to advanced IVL treatments." In the future, the company will collaborate with more doctors to provide faster, safer, and more effective treatment options for patients with complex calcified lesions worldwide. The approval of the Sonico-CX system recognizes the company's technological innovation capabilities and propels the treatment of calcified lesions into a more precise and efficient new phase, injecting new vitality into the global cardiovascular intervention field.

Looking ahead, with its accumulation and innovative spirit in IVL technology, Spectrumedics is expected to occupy an important position in the global cardiovascular interventional treatment market. As the Sonico-CX system advances in commercialization across Europe, the Middle East, and other regions, its clinical value will be increasingly recognized by more doctors and patients, driving cardiovascular interventional technology towards greater precision, safety, and efficiency.

The expansion of IVL technology from coronary arteries to peripheral vascular calcification and valve applications will benefit more patients and open up broader development opportunities for the company. In the future, by deepening the integration of industry, academia, research, and application, Spectrumedics will continue to optimize product performance and explore treatment solutions, providing comprehensive and personalized treatment services for cardiovascular disease patients worldwide and contributing greater strength to the cause of human health.