Domestic companies have created a new situation in the TAVR market and created a new market engine. On August 14, 2024, the State Food and Drug Administration officially approved the domestic Prizvalve transcatheter aortic valve system developed by New Pulse Medical. As the first self-developed balloon-expandable valve launched in China, the Prizvalve valve system is expected to be the first to break the import monopoly, effectively improve the quality of life, and quickly capture market share.

Aortic valve disease mainly includes aortic valve stenosis and aortic valve regurgitation. With the deepening of aging, the prevalence of cardiovascular diseases (including aortic valve stenosis) continues to rise, and the number of patients with aortic valve disease in the world and China has increased year by year. This change has not only had a serious impact on the quality of life of patients, but also posed severe challenges to the medical system.

Traditional aortic valve treatment mainly includes drug therapy, surgical surgery (SAVR) and emerging TAVR surgery. Compared with SAVR, TAVR has the characteristics of no need for thoracotomy and extracorporeal circulation, less trauma, and faster recovery, providing a safer treatment method for patients at high risk of surgery. With the continuous advancement of device design and doctor's technology, TAVR surgery has increasingly consolidated its position in the field of aortic valve treatment, and is expected to dominate the treatment of aortic valve disease and become the mainstream treatment of aortic valve stenosis.

According to Frost & Sullivan, the global TAVR market has expanded from US$1.5 billion in 2014 to US$4.1 billion in 2018, and is estimated to reach US$10.4 billion by 2025, with a compound annual growth rate of 14.3%. Its research on the domestic Chinese market shows that China has 4.5 million patients with aortic valve stenosis in 2021, but the penetration rate of TAVR surgery matching them is only 0.8%. With the intensification of population aging and the increase in the penetration rate of TAVR surgery, the scale of China's TAVR market will reach 11.36 billion yuan in 2030, and is expected to become an important growth point in the field of heart valve intervention.

At present, there are two main types of TAVR approved worldwide, one is the short-stent balloon-expandable valve, and the other is the long-stent self-expandable valve. Among them, balloon-expandable TAVR has become one of the main treatment methods in the field of interventional treatment of heart valve disease in the world, and has achieved significant market share worldwide.

Balloon-expandable valves have the advantages of low incidence of coronary artery obstruction, low rate of permanent pacemaker implantation, and low risk of paravalvular leakage, providing patients with safer and more effective treatment options.

In the field of balloon-expandable valve implantation, imported brands occupy an absolute dominant position, accounting for more than 60% of the global market and more than 100,000 implants per year. As of November 30, 2023, my country has carried out 13,572 TAVR surgeries (37,552 cumulative cases), and the annual implantation volume is expected to be about 15,000 cases, but it is roughly estimated that the proportion of balloon-expandable valve implantation in the domestic market is less than 10%.

In the face of huge market demand, a market innovation of balloon-expandable valves is quietly taking place in China. In terms of expansion mode selection, balloon-expandable valves and self-expandable valves each have their own advantages. The more accurate positioning of the balloon-expanded valve, the valve-in-ring design and the lower stent frame profile help preserve the coronary artery pathway and facilitate subsequent coronary re-intervention. As one of the most commonly used TAVR surgery types, the balloon-expanded valve has high technical barriers, and domestic balloon-expanded valve devices are still in the initial and exploratory stages.

However, with the domestic aortic valve base and industry logic positively improving, the barriers of the domestic balloon-expanded valve market have been broken by domestic companies. As the first self-developed balloon-expandable valve launched in China, New Pulse Medical's Prizvalve valve system truly fills the market gap of domestic balloon-expanded valves. After eight years of research and development, the Prizvalve valve system has completely opened the era of balloon-expanded valve intervention for valvular disease in China.

It is understood that the Prizvalve valve system is suitable for patients with severe degenerative native aortic valve stenosis who are evaluated by the heart team as calcified and are not suitable for conventional surgical valve replacement. The valve frame is made of cobalt-chromium alloy, which has sufficient radial support and can be compressed to a smaller size; the unique tissue processing process can increase the service life of the valve; the internal and external sealing membrane valve skirt design effectively reduces paravalvular leakage. The excellent bending performance of the delivery system can effectively avoid vascular complications and adjust the coaxiality of the valve. The design of the imaging point and the combination of the inner and outer tubes can assist doctors in achieving precise positioning during surgery.

The latest clinical trial data also proves this point. The Prizvalve valve system can prolong and improve the survival of patients for 24 months, and has demonstrated reliable safety and effectiveness in clinical trials. The approval of the Prizvalve valve system has become the first "domino" to leverage the domestic balloon valve market. The technological innovation and competitive landscape of the entire aortic valve market in my country have also changed accordingly, and the era of domestic balloon valve expansion has truly arrived.

Domestic balloon valve expansion finally has the opportunity to compete with imported brands, although this is only the first step. With the accumulation of more clinical trial data and iterative optimization of products, the domestic balloon valve expansion market will also make great strides forward, and the leap in China's heart valve field is already in sight.

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