Domestic Breakthrough in Heart Valve Technology: Prizvalve Pro Pioneers a New Era in Transcatheter Intervention

Made in China, Innovation Launch

On June 24, 2025, Shanghai NewMed Medical Co., Ltd., independently developedThe New-Generation Balloon-Expandable Transcatheter Aortic Valve System Prizvalve Pro Has Successfully Obtained Approval for Marketing from the China National Medical Products Administration!Marks a major leap forward for domestically produced medical devices in the field of heart valve interventional treatment, transforming from once followers to becoming leaders who now stand side by side or even guide the way, ushering in a new era for China-produced heart valve interventional treatment devices on the global stage.

Break Through Technical Barriers, Lead Industry Transformation

In the process of developing Prizvalve Pro, the research team at NewMed faced countless challenges. The development of the delivery system was particularly fraught with difficulties. A pressing issue was how to ensure the valve could precisely reach the diseased area while minimizing vascular damage. The research team worked day and night, continuously refining the design of the delivery system. By simulating the complex environment of human blood vessels, they conducted countless in vitro and animal experiments, making meticulous adjustments to every parameter of the delivery system. Ultimately,Successfully developed a delivery system with precise bending performance and excellent anatomical adaptability., greatly improving the success rate and safety of surgeries. These technological breakthroughs not only demonstrate NewMed's R&D capabilities but also bring new ideas and methods to the field of cardiac valve interventional treatment, leading the transformation of the industry.

Optimized Design, Superior Performance: A Comprehensive Analysis

The key reason why Prizvalve Pro stands out among many similar products lies in its comprehensive optimization and upgrades in design and performance. Every detail reflects NewMed's care for patients and relentless pursuit of technology. Below, let us take an in-depth look at the excellence of Prizvalve Pro in terms of design and performance.

(1) Balloon Design Optimization, Adapting to Small Chambers Reduces Risks

The balloon design of Prizvalve Pro has been optimized for targeted use, with its balloon length carefully adjusted to better fit the anatomical characteristics of patients with small left ventricular structures. The research team collected a large number of case records from patients with small left ventricles, conducting an in-depth analysis of their cardiac structures and physiological parameters, ultimately determining the most suitable balloon length.

In actual surgical procedures, this optimized balloon design can significantly reduce the operational risks associated with small ventricles. In the past, for patients with a small left ventricle, the surgery was difficult and high-risk, akin to performing delicate operations in a confined space, where the slightest misstep could lead to severe consequences. Now, the advent of Prizvalve Pro is like providing doctors with a precise surgical scalpel, which can ensure the effectiveness of the surgery while minimizing risks to the greatest extent. It can more stably adhere to the inner wall of the small left ventricle, reducing stimulation and damage to the ventricular wall, thereby offering patients a safer treatment option.

(II) Upgrade of the delivery system, with multiple safeguards against detachment

The upgrade of the delivery system is one of the highlights of Prizvalve Pro. The new delivery system featuresExcellent Anti-Dislodgement Design, which is the key to ensuring the safety of the surgery. It adopts special materials and structural design, making the valve more stable during delivery and less prone to dislodgement. It is like putting a sturdy suit of armor on the valve, allowing it to "travel" through the blood vessels more safely.

At the same time,The rear stop of the delivery system is welded and shaped with the bending control outer tube to optimize the outer diameter of the rear stop.This welding and molding process is not a simple connection but rather involves strict process control and quality inspection. Through welding and molding, the connection between the rear stopper and the bending control outer tube becomes tighter, with higher stability and better resistance to various forces during the delivery process. The optimized outer diameter of the rear stopper further reduces the risk of valve dislodgement during delivery. During surgery, doctors can operate with greater confidence, without worrying about valve dislodgement, thereby significantly improving the success rate of the procedure.

(III) Tear-off loader, modular flexible expansion

The Tearable Loader is Another Innovative Design of Prizvalve Pro. It features a detachable and tearable design, which provides great convenience for special clinical scenarios. In situations such as an elongated ascending aorta or tortuous vascular pathways, traditional loaders often fail to meet surgical needs due to insufficient length. However, the tearable loader of Prizvalve Pro can easily solve this problem through a "detach-and-tear" operation.

The operator can dismantle the front and rear covers of the loader and tear off the sleeve according to the actual situation, and remove the front cover and sleeve parts, effectively extending the working length of the delivery device. This operation is simple and fast, just like installing a "telescopic extender" on the delivery device, enabling it to freely navigate complex vascular environments. Moreover, Prizvalve Pro can be used in conjunction with NewMed's already approved and marketed "Expandable Sheath Kit," and their coordinated work can further reduce the risk of related vascular complications, providing a more flexible and efficient solution for complex and challenging interventional surgeries.

(4) Reconstruction of the center of pressure grip, with dual assurance of accuracy and stability

Optimization of the Center of Gravity Layout for the Desktop Crimping Machine: A Key Improvement for Prizvalve Pro in the Production ProcessThe optimized center of gravity layout significantly enhances the dynamic stability of the equipment during the valve crimping process, akin to installing a "stabilizer" on the crimping machine, effectively suppressing displacement and shaking during operation. This enhanced stability is crucial for ensuring high-precision crimping, as it greatly reduces crimping deviations caused by equipment vibration or misalignment, guaranteeing precise crimping dimensions and consistent valve morphology.

At the same time, the redesigned handle grip follows ergonomic principles, conforming to the operator's hand habits. When the operator holds the pressing machine, it feels like holding a customized tool, and the firm grip further enhances the precision of operation control. This comprehensive optimization, from equipment stability to operational feel, significantly improves the overall operation experience and provides a strong guarantee for the high-quality production of valves.

(5) Dilatable Sheath Kit, Dynamic Vascular Protection

The Expandable Sheath Kit, as an important complementary product for Prizvalve Pro, features a unique design and functionality. It employs an intelligent dynamic expansion and contraction mechanism, where the sheath compliantly expands as instruments pass through, acting like an elastic conduit that automatically adjusts its size according to the instrument. After the expanded section passes through with the instrument, the sheath retracts back to its original state, preventing prolonged vascular dilation and injury. This dynamic expansion and contraction mechanism significantly reduces the risk of vascular cutting and traction during insertion, making it especially suitable for narrow and tortuous access routes.

In addition, the hemostatic valve structure of the expandable sheath kit is also very unique. It adopts a special design that maintains excellent sealing performance when multi-size instruments pass through. Whether it is small instruments or larger-sized instruments, they can be well sealed when passing through the sheath, effectively preventing blood leakage. The highly compliant tube combined with the hydrophilic coating can improve the efficiency of complex interventional passage, just like applying a "lubricant" to the operation of instruments in blood vessels, making surgical operations smoother. This design establishes a safer vascular access for surgeries such as TAVR and vascular interventional treatments involving repeated instrument operations, reducing the incidence of acute injuries and long-term stenosis complications, and promoting the advancement of minimally invasive interventional treatment safety.

Clinically Verified, Power Proven

The market entry of a medical device requires rigorous clinical validation, as it is directly related to the life and health of patients. Before its launch, Prizvalve Pro underwent strict multi-center confirmatory clinical research. Several top clinical centers in China participated, including the team led by Academician Han Yaling from the General Hospital of Northern Theater Command, the team led by Professor Chen Mao from West China Hospital of Sichuan University, and the team led by Professor Yang Jian from the First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army. The experts from these clinical centers, with their extensive experience and advanced skills, provided solid assurance for the smooth progress of the research.

In actual clinical applications, Prizvalve Pro has performed excellently, successfully performing transcatheter aortic valve replacement for numerous patients with severe aortic stenosis who were at high risk for surgical procedures. Post-surgery, the patients' hemodynamic parameters quickly stabilized, their cardiac function significantly improved, and their quality of life greatly increased. For instance, one patient, prior to the surgery, was severely tormented by aortic stenosis, gasping for breath with even slight movement and barely able to care for himself. After receiving treatment with Prizvalve Pro, his condition gradually improved; not only could he move freely, but he was also able to return to a normal life, with a smile once again appearing on his face.

Multicenter study data show that patients who underwent surgery using Prizvalve Pro achieved key metrics such as one-year postoperative survival rate and incidence of major complications at internationally leading levels. This achievement not only represents high recognition of the performance of Prizvalve Pro but also serves as strong evidence of NewMed's R&D strength and innovation capabilities.

Made in China, Supporting a Healthy China

The launch of Prizvalve Pro is undoubtedly a timely blessing in the field of interventional treatment for heart valves in China, carrying profound and significant implications. For a long time, foreign similar products have occupied a monopolistic position in the high-end market, and domestic patients often need to spend exorbitant costs to receive treatment, which has placed a heavy financial burden on many patient families. The emergence of Prizvalve Pro is like a sharp sword, breaking this monopoly and taking a solid step towards the goal of achieving the localization of innovative medical devices in China.

Its launch provides more high-quality and cost-effective options for medical institutions in China. In the past, when selecting interventional treatment products for heart valves, medical institutions were often restricted by foreign products, which were not only expensive but also had certain issues regarding product compatibility and the timeliness of services. Now, with Prizvalve Pro, medical institutions can choose treatment plans more flexibly based on the specific conditions of patients, providing them with more suitable treatments.

As an advanced medical device independently developed in China, the successful launch of Prizvalve Pro serves as a banner, showcasing the country's strength in the field of high-end medical equipment manufacturing. It demonstrates to the world that China is capable of developing medical device products of international standards. This not only boosts the confidence of the domestic medical industry but also encourages more local companies to increase R&D investment, promoting technological upgrades in related industries.

In advancing the Healthy China strategy, Prizvalve Pro plays an irreplaceable role. The core of the Healthy China strategy is to improve people's health and enable all citizens to enjoy high-quality medical services. By providing safer and more effective treatment options, Prizvalve Pro ensures that more patients with heart valve diseases receive timely treatment, regain their health, and improve their quality of life, contributing to the achievement of the Healthy China strategic goals.

Looking Ahead, Innovation Never Stops

Standing at a new starting point, we have infinite expectations for the future of NewMed. The successful launch of Prizvalve Pro is just an important milestone in the development history of NewMed, not the endpoint. In the future, NewMed will continue to uphold the mission of "Innovation Benefits Life," focus on patients, drive innovation, continuously optimize product performance, and expand the scope of clinical applications.

In terms of product development, NewMed will increase investment, continuously explore new technologies and materials, and commit to developing more advanced, safer, and more effective interventional treatment products for heart valves. For instance, further optimizing the design of the valve to improve its durability and biocompatibility, allowing patients to benefit longer; developing a more intelligent delivery system to achieve precision and automation in surgery, reducing surgical risks.

In terms of clinical application, NewMed will strengthen its cooperation with medical institutions and research universities to carry out more clinical research and trials, promoting the popularization and development of heart valve interventional treatment technology. By organizing academic exchange activities and training courses, it aims to enhance doctors' understanding and mastery of heart valve interventional treatment technology, allowing more patients to benefit from this advanced technology.

We believe that, with the relentless efforts of NewMed, the field of interventional cardiac valve treatment will embrace an even brighter future. More patients will be able to overcome the burden of disease and regain a healthy and happy life. Let us jointly look forward to NewMed achieving more brilliance in its future journey and making greater contributions to the development of global healthcare!