# Research Background

Mitral Regurgitation (MR) is one of the most common heart valve diseases in China. For patients with moderate to severe symptoms, traditional surgical procedures remain the standard treatment approach; however, in elderly patients, those with a history of open-heart surgery, or those with multiple comorbidities, the risks associated with surgical intervention significantly increase.

The patient in this case is74-Year-Old Male,Previously underwent open-chest surgery and exhibits significant frailty (unable to independently perform basic activities of daily living).。After comprehensive evaluation by a multidisciplinary team, the patient was determined to be at high surgical risk.

In such patients, traditional treatment pathways are often limited, andTMVRProvides a potential alternative.

Surgical results showed:

• Artificial valve successfully released and stably anchored

• Immediate disappearance of mitral regurgitation after surgery

• No paravalvular leakage, no left ventricular outflow tract obstruction

• Hemodynamics performed well

The patient recovered smoothly after the surgery, on the5The patient was discharged the next day, and follow-up results further confirmed stable valve function and significant improvement in symptoms.

▲After TMVR surgery

▲Hemodynamics

This case once again confirms:For patients who cannot tolerate surgery,TMVR is gradually transitioning from an "exploratory technology" to a "viable solution."

# AboutProStyle M^®System

Despite the broad prospects, butTMVRThe development has long been restricted by several technical challenges, including:

• Risk of Left Ventricular Outflow Tract Obstruction

• Difficulty in Artificial Valve Anchoring and Sealing

• Complex surgical approach and high operational difficulty

• Hemodynamic Adaptation Issues

Against this background,ProStyle M^®The design of the system reflects a systematic response to the aforementioned issues.

1. Eccentric structure design: ReduceKey Pathway for LVOTO Risk

Left Ventricular Outflow Tract Obstruction isTMVROne of the most challenging complications, which can be life-threatening when severe.

ProStyle M^®AdoptEccentric Valve Frame DesignBy optimizing the spatial layout of the valve, it minimizes the occupation of the left ventricular outflow tract after implantation, thereby reducing the risk of obstruction.

This design not only improves anatomical adaptability but also provides surgeons with a greater margin of operational safety.

2. Anchoring and Sealing: Balancing Stability and Hemodynamic Performance

The mitral valve lacks a natural calcification support structure similar to that of the aortic valve, which makesTMVRFacing greater challenges in anchoring.

ProStyle M^®By optimizing the stent structure design, achieve:

• Stable Anchoring

• Reduce Paravalvular Leak

• Improve Overall Hemodynamic Performance

From the clinical results, the patient in this case did not experience reflux or paravalvular leakage after the surgery, indicating good performance in terms of sealing and stability.

3. Delivery System Optimization: Reducing Surgical Complexity

TMVRThe surgical procedure is complex and requires a high level of experience from the surgeon.ProStyle M^®The delivery system design has been optimized to enhance operational controllability.

At the current stage,"Reducing the learning curve" is becoming one of the key factors in the promotion of TMVR products.

# Core Process Capabilities

In the field of transcatheter valves, long-term durability is one of the key indicators determining the clinical value of a product.

ProStyle M^®Integrated two core proprietary technologies:

• Micro-Ex™Anti-calcification Treatment Technology：By removing residual components in the tissue, the risk of calcification is reduced.

• AirBo™Dry Valve Storage Technology：Achieve dry-state preservation of the valve, enhancing biocompatibility and stability

The synergistic effect of the two is expected to delay the process of valve degeneration.

In the global transcatheter valve competition,"The combination of 'anti-calcification + dry valve technology' is becoming an important direction for product differentiation."

# The Potential Significance of Pure Ultrasound Guidance

Notably, this surgical case was performed inThroughoutPure Ultrasound GuidanceCompleted below, no dependencyXRadiation or contrast agent.

This model has multiple potential values:

• Avoid Contrast-Induced Nephropathy

• Reduce Radiation Exposure for Doctors and Patients

• Reduce Dependence on Large Imaging Equipment

From a broader perspective, this technological approach has the potential to enhance the accessibility of interventional treatments for complex structural heart disease, particularly holding significant potential for promotion within grassroots medical institutions.

# FromFrom FIM to Confirmatory Study

Before entering the confirmatory clinical study,ProStyle M^®CompletedFirst-in-Man（FIM) Research:

• Included10Example Patient 

• Average Age71Year

• All cases achievedStable Anchoring and No Reflux

The launch of this confirmatory study means that the product is“Feasibility Verification”Phase Towards“Clinical Validation of Effectiveness”。

For innovative medical devices, establishing systematic clinical evidence is the key to scaling up applications.

# Made in ChinaAdvancement of TMVR

From a longer-term perspective, this progress is not an isolated event.

Kingstron Bio has been continuously focusing on the field of structural heart disease in recent years, and has formed a product line covering artificial biological valves, annuloplasty rings,Cardiac surgical bio-patches and transcatheter aortic valve products.

This vertical integration capability, from material processing and core technology to end products, provides a foundation for continuous innovation and iteration.

In the high-end medical device field, platform capabilities often have greater long-term competitiveness than a single product.

# Conclusion

AndTAVRDifferent,TMVRA unified technical pathway has not yet been formed, and various products are still continuously exploring in terms of structural design, approach selection, and clinical strategies.

This means:

• The technology roadmap has not yet converged.

• Product competition still in early stage

• The clinical evidence system still needs to be improved.

At this stage, products that can strike a balance between safety, operability, and durability will have greater development potential.

From the successful completion of the first confirmatory study implantation to the official launch of the multi-center clinical study,ProStyle M^®Is experiencing from“Technical Validation”Trend“Clinical Validation”The key transition.

This is not only a progress of a product, but also reflects the advancement of domestically produced products in China.TMVRContinuous breakthroughs in the field of complex structural heart disease.

In the mitral valve"The Final Frontier": China's solution is gradually approaching the true boundary of clinical application.

In the future, as more clinical data accumulates, it remains to be seen whether this domestically produced system can achieve further validation in terms of safety and efficacy. What is certain, however, is:

The competition in the TMVR sector has entered a new stage.