Puchuang Medical's Groundbreaking Forward-Focused Intravascular Lithotripsy Catheter Overcomes Severe Calcified Stenosis and CTO Lesions: A Domestic First

Recently, the first surgery of a landmark clinical trial (FORWARD IVL) was successfully completed at the Cardiology Department of Zhongshan Hospital, Fudan University.Professor Ge Junbo's team from Zhongshan Hospital Affiliated to Fudan University, a member of the Chinese Academy of Sciences, successfully applied the "Single-Use Coronary Intravascular Forward Shock Wave Catheter" jointly developed by Spectrumedics Medical Technology (Shanghai) Co., Ltd. and Zhongshan Hospital to perform precise interventional treatment on a patient with severe coronary artery calcification.

It is reported that the patient had severe diffuse calcification and CTO (chronic total occlusion) lesions, making it difficult for conventional pre-treatment devices to pass through. During the procedure, the forward shockwave catheter successfully reached the lesion area and effectively fragmented the calcified plaque in a "pushing" manner. The entire surgery went smoothly, and the patient remained stable post-operation.

Epidemiological data shows that the incidence of coronary artery calcification (CAC) increases significantly with age, affecting approximately 50% of people aged 40-49 and up to 80% of those aged 60-69. The degree of calcification is positively correlated with the severity of coronary artery stenosis, with coronary angiography revealing that about one-third of lesions exhibit moderate to severe calcification. Dr. Huiqun Peng, CEO of Spectrumedics, introduced that in 2024, the number of PCI procedures in China will reach nearly 2 million cases, of which approximately 5%-8% involve severe stenosis calcification or CTO lesions. It is expected that, with the aging population and increasing burden of cardiovascular diseases, the proportion of such complex cases will continue to rise.

Severe calcified lesions significantly increase the difficulty and risk of percutaneous coronary intervention (PCI), including challenges in device passage, suboptimal balloon expansion, elevated risks of vascular injury, increased complications, poor stent apposition, and worse long-term prognosis. Therefore, severe CAC lesions have always been a major challenge for interventional cardiologists.

Currently, commonly used calcification pre-treatment techniques in clinical practice include balloon angioplasty, coronary rotational atherectomy (RA), excimer laser coronary atherectomy (ELCA), and intravascular lithotripsy balloon angioplasty (IVL). However, these methods all have significant limitations:

● Traditional balloon angioplasty is mostly used for mild to moderate calcification, but for moderate to severe calcification lesions, it has issues such as low success rate, high risk of complications, and poor passability through severe stenosis.

● Plaque旋磨术 (Rotational Atherectomy) has a high technical difficulty, a long learning curve, and a significantly higher complication rate compared to conventional PCI;

● Although laser ablation can be used for some calcified lesions, its effectiveness in treating severe calcification is relatively low.

● Although traditional balloon-type IVL technology has significant effectiveness and reliability, the prerequisite is that the balloon segment must pass through the lesion before effective energy release can occur, thus limiting its application in severely narrowed calcified lesions or CTO lesions.

In the clinical treatment of vascular calcification, safety, effectiveness, and operational simplicity have always been the core goals. Operational simplicity not only requires shortening operation time and reducing the occupation of operator resources but also reflects in lowering the technical learning threshold and shortening the training cycle. However,Faced with complex calcified lesions, especially "challenging" lesions accompanied by extreme stenosis or CTO, interventional physicians worldwide encounter the same dilemma: existing therapies cannot balance safety, efficiency, and simplicity, becoming a major bottleneck in clinical management.

Now, this bottleneck is about to be broken. Spectrumedics has successfully collaborated with the team of Academician Ge Junbo from Fudan University's Zhongshan Hospital to develop the "Antegrade Shockwave Catheter."This product not only retains the safety advantages of shockwave technology but also achieves a revolutionary breakthrough in lesion passability, providing an innovative and efficient solution to the global clinical challenge of severe calcified stenosis and CTO lesions, and pioneering a new path for precision interventional treatment.

Dr. Peng Huiqun pointed out that the forward shockwave catheter has achievedChina's First Balloon-Free Forward Shock Wave TechnologyThe core breakthrough lies in "forward energy emission without balloon conditions," fundamentally distinguishing it from traditional balloon-type IVL.Successfully Solve the "Passability Bottleneck" of Complex Lesions。

The product has overcome two major technical difficulties:

First, traditional IVL relies on the balloon volume to provide sufficient space for electrode discharge and shockwave release, and its technical implementation path has become relatively mature; whereasThe forward shockwave catheter, without balloon structure support, can significantly reduce the space required for electrode deployment and energy regulation component integration. The requirements for device miniaturization and structural precision far exceed those of traditional IVL.Spectrumedics successfully achieved this technological leap through the efficient integration and stability design of key components.

Secondly, the traditional balloon-type IVL adopts a "circumferential" energy release mode, which is suitable for the overall treatment of vascular wall calcification during balloon expansion; the forward shockwave catheter, on the other hand, innovatively adopts a "forward directional" mode.It can precisely target the calcified area when the catheter reaches the front end of the lesion, making it highly suitable for "push-through" treatment of severe stenosis and CTO lesions.

The forward shock wave catheter has the following core highlights:

a、Shows potential to improve passability in clinical applications: This system adopts a unique catheter design that can directly reach severe stenosis areas without the need for a balloon to pre-cross the lesion, effectively addressing the application limitations of traditional balloon-type IVL in complex calcified lesions. Its forward shockwave can precisely loosen the front-end calcified tissue, creating a clear path for subsequent therapeutic devices. On this basis, whether it is balloon-type IVL, high-pressure balloons, scoring balloons, or cutting balloons, all can smoothly pass through the lesion site to perform subsequent treatments.This catheter, as a key innovative solution for channel establishment, lays an important foundation for the comprehensive interventional treatment of complex calcified lesions.。

b、Retain IVL Safety Advantages: The forward shockwave catheter continues the core advantage of IVL technology in "selectively fragmenting calcification".The released shock waves can precisely target calcified plaques, avoiding damage to vascular soft tissues, and are easy to operate., ensuring safety while also taking treatment efficiency into account.

c、HasThe Potential to Simplify Surgical Procedures: Unlike traditional IVL balloons that require repeated "deflation-inflation" operations, this catheter has a self-circulation function, eliminating the need to re-inflate the balloon after each treatment cycle, thus omitting redundant steps.Significantly enhance the convenience and smoothness of surgical operations。

"Spectrumedics and Zhongshan Hospital Jointly Developed 'Single-Use Coronary Intravascular Forward Shock Wave Catheter'"

Dr. Peng Huiqun emphasized: "The forward shock wave catheter was jointly developed by Spectrumedics and Zhongshan Hospital. This collaboration is not only an important innovative practice in the field of coronary interventional medical devices in China, but also marks the in-depth development of the 'doctor-engineering collaboration' model from conceptual exploration to practical implementation. Unlike previous doctor-engineering collaboration models that mostly remained at the conceptual level,Through in-depth and close collaboration between the company and the hospital, a technology that is innovative nationwide and at the forefront globally has been successfully fully clinically translated and applied to patient treatment, effectively verifying the feasibility and practical value of the medicine-engineering collaborative model.”

During the product development process, Spectrumedics places "the combination of medical and engineering" in a very important strategic position. "The combination of medical and engineering is not a phased cooperation, but a continuous process throughout the entire product life cycle.It is necessary to promote the deep involvement of clinical practice in all key nodes of the entire process, rather than just staying at the initial stage of demand."." Dr. Peng Huiqun said, which is also the most valuable experience for the company in promoting the development of medical-engineering integrated products.

Spectrumedics always maintains close interaction with the clinical end, promptly listening to and incorporating the suggestions of clinical experts. At the same time, it dynamically advances product iteration and optimization by combining the company's technology R&D planning with its overall development strategy. The development of this forward shockwave catheter is a model example of Spectrumedics' medical-engineering integration approach.

In 2023, China's shockwave technology gradually entered the clinical application stage. Academician Ge Junbo, recognizing the clinical limitations of traditional balloon-type shockwave catheters, proposed the innovative concept of "developing a non-balloon-type shockwave catheter." Considering Spectrumedics' deep cultivation in the IVL field and its solid technical accumulation and R&D capabilities, he reached out to the company and initiated a collaborative research and development effort.

After learning about this need, Spectrumedics quickly responded and immediately initiated the R&D work. The company developed the first-generation product prototype in a short period. Thereafter, the team closely collaborated with clinical experts, gathered feedback through model trials, rapidly iterated and optimized, and ultimately completed the product design freeze, laying the foundation for subsequent clinical translation.

This is due in part to Spectrumedics' technical accumulation, with an in-depth understanding of shock wave technology and a strong technical foundation in the early stages, which has laid a solid foundation for Spectrumedics to carry out extended technology research and development on the same technical platform and achieve rapid iteration; on the other hand, it is also due toSpectrumedics Builds a Core Team with Deep Integration of Clinical and Technical Expertise。

According to Dr. Peng Huiqun, Spectrumedics has a professional medical team whose members all have clinical backgrounds in cardiology. They can deeply understand the actual treatment needs on the clinical side and maintain high-frequency, in-depth close communication with the company's technical department. This also creates one of the core advantages of Spectrumedics in the combination of medicine and engineering——Possess the ability to accurately translate clinical needs into engineering and technical language, breaking down communication barriers between clinical needs and technical implementation.。

On the one hand, the team can accurately capture and break down the requests put forward by clinical experts, transforming them into engineering metrics that are comprehensible and executable for the R&D end; on the other hand, it can also feedback the difficulties and boundary conditions in technical development to the medical team in a clinically perceptible manner. While building an efficient collaboration bridge between clinical and engineering, this approach achieves a dynamic balance among core clinical needs, technical feasibility, and commercialization goals, ultimately allowing innovative technologies to benefit patients.

With outstanding medical-engineering integration capabilities and innovative R&D strength, Spectrumedics has established international competitiveness in the IVL field.In the field of balloon IVL, the company has developed the world's first IVL system capable of delivering up to 120 pulses with a single catheter.; At the same time, the company quickly realized the application limitations of traditional balloon IVL and rapidly launched the forward shockwave catheter. According to Dr. Peng Huiqun, Spectrumedics' overall R&D phase in the IVL field has kept pace with the international frontier, and it has differentiated advantages in some technical paths. The company always integrates independent innovation ideas in specific technical implementation paths and core performance design of products, forming a technical solution with its own characteristics and avoiding homogeneous R&D.

Next, Spectrumedics plans to expand the application of IVL technology to broader scenarios such as heart valves and peripheral interventions, while continuing to broaden its commercial footprint. It is reported that Spectrumedics has already achieved commercialization in major markets in Latin America and Southeast Asia. The company will soon make a rapid entry into the European market and subsequently advance into the North American market.

The company will continue to take clinical needs as the fundamental guidance, deeply integrate technological innovation into the entire process of IVL technology research, development, and application, continuously optimize vascular treatment solutions, further enhance the safety and effectiveness of treatments, and ultimately strive to become a global leader in IVL technology and vascular treatment.