Medtronic's Transcatheter Aortic Valve System Approved as China's 8th TAVR Product by NMPA

Today, according to the official website of the National Medical Products Administration, Medtronic's innovative product, the "Transcatheter Aortic Valve System," has been approved for marketing. It is suitable for patients assessed by a heart team (including cardiac surgeons) as high-risk or higher-risk for surgical procedures, with symptomatic calcification.Patients with Severe Aortic Stenosis. Becomes the 8th product in China's domestic aortic valve treatment field.

The message shows that the product is aRetrievable、Transcatheter implantationThe aortic valve replacement system consists of a transcatheter-delivered artificial heart valve (aortic valve), a delivery catheter system with a handle, and a crimping and loading system for compressing the artificial bioprosthetic valve into the delivery catheter system.

Among them, the valve leaflets and inner skirt are made of a single layer of porcine pericardial membrane, sutured and fixed onto a nitinol stent, with an outer skirt made of porcine pericardial tissue.Dual inner and outer skirt design effectively prevents paravalvular leakage.。

Moreover, the product can be withdrawn or retrieved before full release for intraoperative repositioning, reducing the risk of paravalvular aortic regurgitation caused by poor positioning of the bioprosthetic valve.

At the same time, the special design of its delivery system allows for the use of the delivery system without a separate catheter sheath, which helps to reduce the risk of vascular access complications.

In terms of product performance, there is no significant difference compared to the eight aortic valve products currently on the market. Features such as double-layer skirt (to reduce paravalvular leakage), self-expanding, retrievability, smaller delivery system size, and pre-loading have become common indicators. Moreover, most adopt the transfemoral vein approach for implantation.

But among a range of products, only J-Valve by Suzhou Jiecheng includes aortic regurgitation as an indication, while the rest are used to treat aortic stenosis.

As one of the two major aortic diseases, aortic regurgitation accounts for 80% of all patients with aortic conditions.Thus, there remains a large patient population with unmet needs.。

Not only that,The price of transcatheter aortic valve replacement surgery remains relatively high in clinical practice.Data shows that the price of intraoperative valves ranges from 196,000 to 298,000 yuan, and the cost of the entire surgery ranges from 226,000 to 328,000 yuan.This has, to a certain extent, curbed the commercialization of the product.Public data shows that in 2020, only 3,600 transcatheter aortic valve replacement surgeries were performed in China.

But overall,Although the aortic valve market in China is still in its early stages, it has actually captured a significant share of the domestic market, and the technology is also developing relatively quickly.In 2020, the市场规模 of heart valves in China was approximately 20 billion RMB, with aortic interventional treatments accounting for over 6 billion. Additionally, there are 10 products in feasibility or confirmatory clinical trial stages.

While the structural and procedural complexities of mitral and tricuspid valve interventions are still in their initial stages, with no products yet commercialized, the population of patients with mitral valve disease alone is 5 to 10 times that of patients with aortic valve disease, yet less than 1% undergo surgical treatment.

Therefore, in the future, transcatheter aortic valve products need to continuously optimize aspects such as selecting appropriate valve lengths, extending the lifespan of biomaterials, and reducing the implantation pathway. At the same time, they must also include medium- and low-risk patients in the indications while tackling more challenging indications to expand market space, reversing the sluggish performance of domestically produced valve manufacturers in the secondary market since the beginning of this year.