"Small Steps, Great Leaps": Another IVL Product Gains Approval as the Market Enters a Rapid Expansion Phase
The field of intravascular shockwave therapy (shockwave balloon) welcomes a new member once again.
In March 2025, Shanghai Jiamuyao Medical Technology Co., Ltd., dedicated to providing an energy platform with comprehensive solutions for complex pan-vascular lesions, successively obtained the NMPA registration certificates for its Intravascular Shock Wave Therapy Device (NMPA Registration No. 20253010366) and Disposable Coronary Intravascular Shock Wave Catheter (NMPA Registration No. 20253010543).When used in combination, they are indicated for the pretreatment and balloon dilation of primary calcified coronary artery lesions in adult patients prior to stent implantation.
With the market launch of Jiampow's shockwave balloon product, patients will gain access to a high-quality therapeutic option and greater flexibility in the treatment of coronary artery calcification.
In clinical practice, calcified lesions often lead to irregular intimal tearing during the procedure, poor stent apposition, and an increased risk of in-stent thrombosis postoperatively, thereby elevating the risks of heart failure and even sudden cardiac death. For patients with coronary artery disease and calcified lesions, conventional stenting techniques often fail to achieve optimal apposition, resulting in incomplete stent expansion, poor apposition, and a higher probability of restenosis. Therefore, physicians typically perform adequate pre-treatment of the calcified lesions prior to stent implantation. However,Previous solutions for coronary artery calcification pretreatment have certain limitations:
Taking high-pressure balloons, spinous process balloons, and chocolate balloons as examples, these devices are often targeted at mild to moderate calcified lesions; however, their use may be associated with high rates of vascular dissection and acute vessel occlusion. Cutting balloons can largely avoid these issues, but their structural design imposes stringent requirements on vessel diameter and angulation, thereby limiting deliverability. In contrast, coronary atherectomy and rotational atherectomy demand high operator proficiency, involve a steep learning curve, and are mastered by relatively few clinicians in practice; furthermore, these procedures are time-consuming and carry an elevated risk of vascular injury.
To better address this issue,IVL (Intravascular Lithotripsy) has emerged as a solution—delivering pulsed acoustic pressure waves to calcified lesions via a balloon catheter to “fracture” calcified plaques, thereby facilitating vascular recanalization while avoiding damage to the vascular intima.This technology has also been hailed as the “terminator” of coronary artery calcified lesions in the Chinese Expert Consensus on the Diagnosis and Treatment of Coronary Artery Calcified Lesions.
The intravascular lithotripsy (IVL) treatment device and single-use coronary intravascular lithotripsy catheter recently approved for Shanghai Jiamuyao both utilize IVL technology. Compared with other intravascular lithotripsy devices currently approved in China, Jiamuyao’s products exhibit certain distinctions.Beyond the conventional catheter identification function and preset treatment procedures, Jiamuyao has deeply integrated actual clinical needs and the necessities of scenario-based usage to “re”design the product:
In terms of vascular shockwave therapy devices，On the one hand, it adopts a vertical design., resulting in a smaller footprint for easier surgical positioning;On the other hand, it features a unique foot pedal switch design.Jiamuyao recognizes that physicians employ multiple medical devices during the management of complex vascular lesions, where operative space is limited. By utilizing a foot pedal to control pulse delivery, inadvertent device displacement caused by accidental contact is avoided.In addition, the device is powered by a 220V power supply.Jia Muyao pointed out that the built-in battery power supply method increases the risk of energy attenuation and the burden on medical staff, requiring constant attention to battery levels. In contrast, energy is more concentrated after conversion from 220V AC power, and only a power connection is needed during surgery.
In terms of shockwave balloon catheters, Jiamuyao has comprehensively avoided the issue of deliverability associated with specialized balloon catheters by adopting innovative materials and tapered design.Based on feedback from the clinical research centers participating in the pre-market studies of this product, there is a high level of satisfaction with its performance in traversing diseased tissue. In addition, this product adoptsThe dual shockwave generator maintains uniform energy distribution along the straight segment of the balloon, ensuring treatment stability.To better ensure pushability and distal flexibility, it adopts a push-rod design with a stainless steel tube at the proximal end and polymer material at the distal end; furthermore, a dual-layer hydrophilic coating is applied to facilitate smoother delivery.Meanwhile, to address the issue of physicians’ mobility radius, JiamuyaoThe product is also equipped with a balloon catheter tail wire.
Jiamuyao’s innovatively designed products, tailored to clinical needs, have earned high recognition from clinicians for their stringent manufacturing and quality standards. The first clinical enrollment of Jiamuyao’s shockwave balloon product was completed in October 2022 by the team led by Professor Tang Yida, Vice President of Peking University Third Hospital and Executive Deputy Director of the Institute of Vascular Medicine.Multiple clinical trial centers, including Peking University Third Hospital and Beijing Anzhen Hospital, have given high praise to the Jiamuyao shockwave balloon product.
“Amid the launch of multiple products, what enables a product to stand out from its peers is product quality and reasonable pricing. As a Chinese enterprise, it is our responsibility to actively support national healthcare reforms and medical device procurement initiatives, explore the optimal balance between quality and price, and provide clinically viable products that are both high-quality and affordably priced. We do not intend to engage in disorderly competition through low-price strategies. Instead, we aim to enhance our competitiveness by strengthening the optimized management of our raw material supply chain, implementing rigorous quality control during production, and improving after-sales services, thereby reaching the market at reasonable prices,” stated Jia Muyao.
For Jiapuyao, shockwave balloon-based therapy for vascular calcification still holds significant room for expansion.
On one hand, in the treatment of coronary artery calcification, the growth in the volume of percutaneous coronary intervention (PCI) procedures will further drive the increased use of Jiameiyao’s approved coronary intravascular lithotripsy balloon products.Relevant data indicate that, as a key therapeutic intervention for coronary heart disease (CHD), the volume of percutaneous coronary intervention (PCI) procedures has been increasing year by year with deepening population aging. Data presented at the Chinese Chest Pain Center Conference show that the number of PCI procedures in China rose from 228,000 in 2009 to 1.636 million in 2023. Except for a negative growth in 2020 due to the pandemic and other factors, the annual growth rate of PCI cases ranged from 11.15% to 26.44% between 2010 and 2023. According to Frost & Sullivan statistics, the global market size for intravascular lithotripsy (IVL) devices used in coronary artery disease is projected to reach USD 3.347 billion by 2030.
On the other hand, in the field of peripheral vascular calcification treatment, Jiamuyao has also proactively laid out its peripheral shockwave balloon product, which has entered the clinical trial phase.Approximately 6% of adults worldwide suffer from peripheral vascular disease. Among these cases, lower extremity arterial disease is the most common, accounting for 80% of all peripheral arterial disease cases. In 2021, there were approximately 52 million patients with peripheral arterial disease in China. However, due to the slow progression of peripheral vascular disease and the early stage of development of vascular surgery in China, the penetration rate of interventional procedures has been relatively low, resulting in significant unmet clinical needs. According to Frost & Sullivan data, the number of peripheral arterial interventional procedures in China was 163,000 in 2021 and is projected to reach 602,000 by 2030 (CAGR = 15.6%). This undoubtedly represents a market with substantial growth potential.
In fact,Jiamuyao’s goal is to build a leading energy platform in China for comprehensive solutions to complex pan-vascular lesions.Currently, in addition to the aforementioned shockwave balloon products, multiple other innovative products are also steadily advancing through research and development.
Now that its coronary intravascular lithotripsy (IVL) balloon product has received regulatory approval for market launch, Jiapuyao is actively advancing production and market expansion efforts. According to the company, its current manufacturing facility can meet the demand for the first year of commercial availability, with plans to further scale up capacity as product volumes increase. In terms of market development, Jiapuyao is proactively establishing partnerships with hospitals and providing trial products to enhance physician satisfaction and build positive word-of-mouth, thereby laying a solid foundation for rapid future market penetration.
It is worth noting that, in terms of market expansion, Jiawayao’s ambitions extend beyond the domestic market.
Even before the product was officially approved for market launch,In December 2024, Jiapuyao publicly disclosed its international patent for the Coronary Intravascular Lithotripsy System.Previously, the shockwave balloon product from industry leader Shockwave was priced at 30,000 yuan, a level that was not patient-friendly. With the market launch of Jiapuyao’s shockwave balloon product, prices in this category are expected to decline further into a more reasonable range. As Jiapuyao steadily expands its domestic market presence, it will also venture overseas to compete on the global stage with its international peers.