JensCare's Prostyle A®, World’s First Pre-mounted Dry TAVR System, Receives NMPA Approval

April 9, 2025, by"Kingstron Bio" independently developedProstyle A®Transcatheter Aortic Valve Replacement System - Dry Pre-assembly and Retrievable Delivery System Approved by National Medical Products Administration (NMPA)Approved for Marketing(National Medical Device Registration Certificate 20253130729).

As the world's first pre-installed dry valve, Kingstron Bio launches a new generation of interventional aortic valve.Prostyle A®Integrates numerous cutting-edge technologies in the field of valves, featuringDry valve technology, ingenious and convenient pre-loading system, excellent hemodynamic performance and durability of the valve, superior deliverability and passability, smooth deployment, and reliable anchoring.Features.

Kingstron Bio's independently innovated dry valve technology is patented in China, Europe, the United States, Japan, and other countries. This unique technology not onlyMake Pre-installation Possible，Eliminates the inconvenience for doctors to assemble the valve on-site in the operating room., while also endowing the valve with greener performance. Compared to traditional wet valves preserved in aldehyde solution, it eliminates the risk of aldehyde residue, offers better biocompatibility, effectively slows down the calcification process of biological valves, and extends the service life of the valve. The emergence of this product marks a significant advancement.China's TAVR Enters a New Era — The Dry Valve Era, and we believe that in the near future, more dry valves will emerge internationally, benefiting patients.

In product configuration,Prostyle A®With a low stent frame and waist-reduction design, it offers balanced radial support and a small taper angle, along with an extended full-sealing zone. Its highly stable deployment and ability to expand in patients with severe calcification are the first impressions clinicians have of this product. Additionally, the delivery system features a compliant, patented design with a minimum outer diameter of just 18F and optional integrated sheath options, equivalent to a 14Fr/16Fr system. Its excellent arch-crossing performance has been well-validated in clinical trials, demonstrating strong results in cases such as small-angle aortic arches and horizontal hearts. The ultra-smooth coating on the distal end ensures smooth passage through the arch and minimizes the risk of dissection.

The excellent performance of this valve in the registered clinical trial has left a deep impression on clinical experts. As is known to all, the incidence of bicuspid valve patients in the Asian population is significantly higher than that in Western populations, and bicuspid valves are more challenging compared to tricuspid valves. Among the enrolled patients for this product, approximately 50% were patients with calcified bicuspid valves, and even under these circumstances, this valve still demonstrated very outstanding performance. It is worth mentioning that pacemaker implantation has always been a common complication after TAVR procedures because the implantation of the valve can affect the nerve conduction tissue below the valve. We are pleased to see that, in the clinical trial, this product...The implantation rate of pacemakers has been reduced to a leading level in the industry., which benefits from the ingenious stent design, smooth and accurate release, and the optimized option of multiple retrievals and repositioning of the valve.

Since its establishment, Kingstron Bio has adhered to its original aspiration and remained steadfast, consistently staying at the forefront of innovation, possessingMore than 80 patents domestically and internationally。In 2018, after the mitral annuloplasty ring was launched, the tricuspid annuloplasty ring, aortic valve bioprosthesis, mitral valve bioprosthesis, and bovine pericardial patch were successively launched.Kingstron Bio, relying on advanced material processing technology, is deeply rooted in the field of heart valves. Its products have gained strong market trust and user recognition, especially its annuloplasty rings, which boast leading sales among similar domestically produced medical consumables in China.

This timeProstyle A®The approval provides the market with higher-quality product options, serving a wide range of patients and doctors, marking another step forward for Kingstron Bio. Meanwhile, the transcatheter mitral and tricuspid valve replacement systems, as well as the artificial biological heart valve (dry valve), are currently undergoing clinical trials. In the future, Kingstron Bio will continue to upgrade its products, closely align with clinical needs, focus on the field of heart disease, and develop more high-quality, high-performance products. These innovations aim to contribute safer and more efficient medical solutions for patients in China and around the world, promoting the flourishing development of global healthcare.

Source: Kingstron Bio