China's High-End Medical Device Innovation Scores Another Breakthrough: First Domestic Transcatheter Valve for Aortic Regurgitation Approved

From the past "open-chest" treatment to today's minimally invasive surgery, a small artificial heart valve originating from China may help tens of millions of aortic regurgitation patients worldwide regain new life.

On September 5, the Securities Times learned from JANS Medical that the second-generation interventional artificial aortic valve product "J-Valve® TF Transcatheter Aortic Valve System (referred to as: J-Valve TF Valve)" independently developed by its subsidiary CAUSPER MEDICAL had officially received approval from the National Medical Products Administration (NMPA) for market launch on September 1. The product can effectively treat aortic regurgitation, a globally challenging disease, through minimally invasive methods and holds over 200 international patents and patent applications.

Dual Indications Fill the Gap and Innovate Again

CAUSPER MEDICAL, founded in 2009, is one of the earliest companies in China to engage in the research and development of Transcatheter Aortic Valve Replacement (TAVR) products. Its first-generation product, the "J-Valve® TA Transcatheter Bioprosthetic Heart Valve (referred to as: J-Valve TA Valve)," was approved for marketing by the NMPA in 2017. It uses a transapical approach (requiring a small incision at the patient's apex) and is one of the earliest domestically produced TAVR products approved in China. It is also the first transcatheter valve product capable of simultaneously treating severe aortic regurgitation and stenosis with dual indications. Since its approval, the product has been used in nearly 200 major hospitals in China, including Beijing Anzhen Hospital and Shanghai Zhongshan Hospital, and has cumulatively treated more than ten thousand patients. Due to its excellent clinical performance, it has received high recognition from experts in the field.

It is worth mentioning that the company's new generation product, J-Valve TF valve, adopts a transfemoral approach (only requiring access through the blood vessels in the thigh). It can treat patients with regurgitation of different anatomical structures, as well as those with both regurgitation and stenosis. This product has the advantages of less surgical trauma and faster patient recovery, reducing hospital stays and lowering the medical costs associated with perioperative management.

Professor Wang Chunsheng from Zhongshan Hospital, Fudan University, the principal investigator of the product's clinical research in China, mentioned: "The J-VALVE TF valve can effectively treat aortic regurgitation, especially in treating pure non-calcified aortic regurgitation. This valve has unique advantages and demonstrates excellent clinical performance."

Public data shows that in 2020, the number of patients with aortic valve stenosis worldwide reached 20 million, with 4.4 million in China; it is expected that by 2030, the global number of patients will exceed 23 million, with 5.2 million in China. The number of patients with aortic valve regurgitation globally and in China is comparable to those with aortic valve stenosis. Aortic valve disease is closely related to aging. Among people over 65 years old, about 2% suffer from severe aortic valve regurgitation.

However, relative to the millions of patients, the annual number of Transcatheter Aortic Valve Replacement (TAVR) procedures performed in China is very limited. In 2024, there are only about 17,000 TAVR procedures (including treatments for stenosis and regurgitation) conducted in China, indicating a low penetration level, which is far below that of the United States (where the TAVR treatment penetration rate is over 15%). The market potential in China is enormous.

Chinese Originals Gain Recognition from Overseas Giants

Notably, due to CAUSPER MEDICAL's unique innovative initiatives, in August last year, Edwards Lifesciences, a global cardiovascular giant from the United States, acquired the overseas rights to the J-Valve. This transaction represents the first truly significant technology export in China's medical device field, showcasing high-end innovation originating from China with independent intellectual property rights.Innovative HealthcareThe device has gained recognition from top American companies for the first time.

According to the first large-sample ultrasound database-based survey study in the United States, the prevalence of moderate or severe aortic regurgitation among adults aged 18 years and older is as high as 2.33%. Patients with aortic regurgitation typically exhibit characteristics such as annulus dilation and lack of leaflet calcification. Currently approved interventional aortic valves in the U.S. can only treat aortic stenosis, leaving a large number of patients with aortic regurgitation to undergo open-heart surgery or receive conservative medical treatment. Against this backdrop, the "J-Valve TF Valve," a product originating from China, has been proactively invited by several clinical doctors in North America to initiate humanitarian assistance in the U.S., even before the product's approval.

At the beginning of 2024, the J-Valve TF valve successfully completed the FDA early feasibility clinical trial in the United States. Clinical results confirmed the safety and effectiveness of the product (surgical success rate of 93.3%, intraoperative mortality rate of 0%, and 30-day follow-up data showing that 100% of patients had postoperative aortic regurgitation reduced to mild or below). Edwards, as the global leader in the heart valve field, has deeply cultivated the industry for many years and fully understands that patients with regurgitation lack effective clinical interventional treatment methods. Perhaps precisely because of this, Edwards subsequently quickly reached an agreement with Causper Medical for the transfer of overseas rights. Currently, Edwards has already started the FDA pivotal clinical trial for the J-Valve TF valve in the United States.

"Medical devices, as a typical representative of high-end manufacturing, are characterized by high technological content, complex industrial chains, numerous细分(subdivisions) of industries, and strict regulatory oversight." Industry insiders believe that due to humanity's universal pursuit of health, medical device products have universal applicability on a global scale. The overseas success of the J-Valve demonstrates that innovative achievements capable of effectively addressing clinical needs will gain a global passport.