Spectrumedics Announces Breakthrough Domestic Intravascular Lithotripsy System Co-Developed with Academician Ge Junbo's Team

With the breakthrough of emerging technologies such as biodegradable stents and drug-coated balloons, coronary interventional consumables, with their advantages of minimal invasiveness, rapidity, safety, and effectiveness, have captured nearly 90% of the market share, becoming the most active track. Not only are start-up companies emerging in large numbers, but also 13 cardiovascular consumable enterprises in China have moved towards IPO.

In 2020, global cardiovascular device financing witnessed explosive growth, with the total funding amount increasing by 237% year-on-year. In China, the cardiovascular device sector accumulated $1.313 billion in financing in 2021, marking a 40% year-on-year increase. The potential for growth in this field is evident.

Trends in Global Cardiovascular Device Company Financing from 2015 to 2021

Data source: VBInsight

Breakthroughs in technology and continued capital investment have brought more possibilities for the development of the industry, with innovative solutions for cardiovascular interventional therapy emerging continuously. One such solution is the use of shockwave energy to uniformly crack circumferential calcified plaques.

It is understood that,This technology was innovatively achieved by Spectrumedics Medical Technology (Shanghai) Co., Ltd. ("Spectrumedics"), a pioneering medical technology enterprise focused on integrating energy platforms with vascular interventional techniques, marking a breakthrough in domestically produced innovations.

In 2021, the team led by Academician Ge Junbo successfully performed PCI interventional treatment on a 59-year-old patient with severe coronary artery stenosis and heavy calcification using this system. The project was also reported at the annual meeting of the National Radiology and Clinical Research Center.

In fact, coronary atherosclerosis is not only the pathological basis of coronary heart disease but also the main lesion causing myocardial infarction and cerebral infarction, resulting from calcified plaques deposited within the vascular walls. Coronary atherosclerosis can lead to narrowing of the coronary artery lumen, rupture of unstable plaques, bleeding, as well as arrhythmia, heart failure, and even sudden death, severely threatening the patient’s quality of life and survival. Therefore, finding a treatment for coronary atherosclerosis is particularly crucial.

However, the severity of the problem lies in the fact that the calcified plaque is encapsulated within the endothelial cells and the internal elastic membrane. The calcium in the plaque hardens the narrowed blood vessels, hindering vascular dilation treatments. Existing therapies such as balloon angioplasty, stent implantation, and drug-eluting devices still exhibit some degree of inadequacy in treatment outcomes.

Some balloon treatment forms have pain points such as insufficient expansion, assisted vessel dilation, and a "dog bone" shape. Relevant studies show that non-compliant (high-pressure) balloons tend to expand in non-calcified areas and often cause dissections and perforations at the interface between calcified and healthy tissue, unable to effectively modify calcified plaques, resulting in limited vascular dilation effects.

As the preferred solution for treating severe calcification currently, rotational atherectomy has a steep learning curve and a relatively low adoption rate. The high-speed rotation of the burr may also cause thermal injury, increase the risk of thrombosis, and raise the probability of complications such as dissection, perforation, and slow blood flow. Moreover, if the calcified particles generated by rotational atherectomy are larger than 10 μm, they can lead to distal embolization.

If calcified lesions are not properly pre-treated, factors such as incomplete stent expansion, poor apposition, and irregular deformation may lead to increased rates of immediate postoperative residual stenosis, restenosis, and thrombosis. Drug-eluting devices need to address the issue of calcified plaques forming a barrier that hinders drug delivery to target cells within the vascular media, affecting drug delivery efficiency.

Spectrumedics' Sonico Intravascular Lithotripsy Balloon Catheter System provides a solution for the treatment of arterial vascular calcification.

Sonico Intravascular Lithotripsy Balloon Catheter System

Sonico Intravascular Lithotripsy Balloon Catheter System utilizes acoustic energy to directly target calcified plaques within the intima and media, emitting shockwave energy 360 degrees to uniformly crack circumferential calcified plaques and restore vascular compliance.

At the same time, the system's operation process is fast and simple. The doctor only needs to pass the shockwave catheter over the guidewire through the calcified lesion, inflate the balloon to 4atm to adhere to the vessel wall. Then, connect the shockwave catheter to the device, which can automatically identify the catheter specifications and adjust the output energy. Finally, the doctor uses a foot pedal switch to initiate treatment, and the micro-transmitter set inside the balloon generates the shockwaves.

After completing the above operations, the sound waves will pass through the balloon and vascular soft tissues, shattering the calcified plaques within the blood vessel walls. This restores vascular compliance while keeping the calcified plaques in place. The balloon will then expand the lesion area at a low pressure (8 atm), further increasing the lumen size. Subsequently, the doctor can decide whether the patient requires further treatments such as stent implantation or drug-coated balloon therapy.

According to the currently available clinical data, the system is safe, effective, and can simply and quickly address the pain point of severe arterial calcification in vascular interventional therapy.

It is reported that Spectrumedics launched the registration clinical trial of Sonico-PX (Peripheral Shockwave Balloon), the first domestically produced peripheral intravascular shockwave lithotripsy system in China, in November 2021. In December, Spectrumedics completed the first clinical enrollment for Sonico-CX (Coronary Shockwave Balloon). The results of both trials showed that they met the primary endpoints, with no device-related adverse events occurring.

In Vitro Calcification Model Testing

In Vitro Calcification Model Testing – Efficacy Validation

Preclinical animal experimental results indicate that the safety and operability of Shockwave Balloon Angioplasty are comparable to those of POBA. The histological response of healthy arteries to shockwaves is relatively mild. Shockwaves can propagate through the walls of healthy arteries without causing severe vascular tissue damage, particularly endothelial denudation.

Preclinical Validation – Animal Experiments

According to Peng Huiqun, the founder of Spectrumedics, compared with the application of shock wave lithotripsy in urology, cardiovascular interventional therapy demands higher precision and safety. Therefore, more effort is required in the miniaturization of the development of shock wave balloons. At the same time, due to safety considerations, balancing product efficacy with safety during the R&D process is a major challenge. This requires continuous product testing and subtle design adjustments to meet the requirements for precision, safety, and effectiveness.

Within three years of its establishment, the team completed the development of the only domestically produced and self-developed shock wave balloon product to receive patent authorization in China, and verified the product's safety through clinical trials. The ability to quickly identify solutions to clinical pain points and achieve product development progress is inseparable from the support of the team.

It is reported that Huiqun Peng pursued her Ph.D. in Biology at Nanyang Technological University in Singapore, under the research group affiliated with Nobel laureate Professor Sydney Brenner. She has held key positions in product development, project management, clinical research, and business development at MERCI (Singapore's national-level medical device incubator). Dr. Peng has accumulated extensive experience in the research and development of Class III cardiovascular innovative devices, formulation of patent strategies, clinical research, and team building.

Al Ray Tabiliran, the co-founder, has over a decade of experience in balloon development and a dual background in electrical and mechanical engineering. After graduating from university, he worked for several electrical and electronic product companies, responsible for product development and manufacturing. In 2008, he entered the medical device industry, working at balloon catheter manufacturers Creganna Tactx Medical and TriReme Medical, where he was in charge of production, quality, and technical development. During his time at TriReme Medical, he was deeply involved in the development of the innovative "Chocolate" balloon device.

The prevalence of cardiovascular disease in China continues to rise. According to the "China Cardiovascular Health and Disease Report 2020," the number of people with cardiovascular disease in China has reached approximately 330 million. As a primary treatment for cardiovascular diseases, vascular interventional surgery still presents significant challenges. Fortunately, related fields such as surgical robotics, AI medical imaging, and cardiovascular consumables have achieved substantial progress driven by increasing market demand and technological advancements, offering more possibilities for the treatment of vascular interventional diseases.

Driven by the continuously increasing market demand and the development trend of integrating engineering with medical devices, Spectrumedics will further expand its product portfolio based on its existing energy platform in the future. Focusing on interventional treatments for pan-vascular diseases, the company will combine its energy platform with multiple technologies to cover a wider range of indications. At the same time, it will extend the application areas of its core technology to provide comprehensive solutions.