Medtronic's SimuForm® Mitral Valve Annuloplasty Ring Achieves First Implantation in Guangxi, China

Aug 14, 2025 11:31 CST Updated 11:31

Medtronic

Medical Device Manufacturer

Heart Future

Recently,Nanxishan Hospital of Guangxi Zhuang Autonomous RegionCardiovascular and Great Vessels SurgeryDirector Pan Yuchen's TeamSuccessfully completedMedtronic SimuForm^®Mitral Valve Annuloplasty RingTheFirst Implant Surgery in Guangxi, marking the official launch of Medtronic's innovative device in the field of mitral valve repair in Guangxi, offering new treatment options for local patients with heart valve disease.

# Research Background

In recent years, with the aggravation of population aging and the increase in the incidence of cardiovascular diseases, the number of patients with mitral valve disease has been constantly rising. Traditional treatment methods mainly include medication and valve replacement surgery. However, medication can only alleviate symptoms and cannot cure the root cause; while valve replacement surgery, although highly effective, involves significant surgical trauma and carries a certain risk of complications. Therefore,Mitral Valve RepairAs a minimally invasive treatment method that preserves the function of the native valve, it has gradually gained clinical attention.

In mitral valve repair,Transcatheter Mitral Valve RepairHas become a future development trend, among which the edge-to-edge repair technology based on the mitral valve leaflets is the most mature and is currently the mainstream repair procedure.

However,Although the "edge-to-edge" repair of the mitral valve leaflets has achieved great clinical success, this technique is not without its imperfections., other different mitral valve repair techniques continue to emerge. Transcatheter mitral annuloplasty is a technique that competes with the "edge-to-edge" repair of the mitral valve leaflets. Unlike transcatheter edge-to-edge repair of the mitral valve,Annuloplasty interventional products have high technical barriers, are difficult to operate, and have a long learning curve.，It is one of the most technically challenging procedures, and its development has also been relatively slow.。

Compared with mitral valve replacement, mitral valve plasty has two advantages.：

(1) Avoid anticoagulation

For young patients, valve repair does not require anticoagulation, whereas replacement with a mechanical valve necessitates anticoagulation. Mechanical valves may lead to thromboembolic complications (causing stroke and valve dysfunction) and spontaneous bleeding (due to anticoagulation), which are not associated with valve repair.

(2) Preservation of Cardiac Function

Many clinical and laboratory studies have demonstrated that valvuloplasty preserves cardiac function, while valve replacement leads to a 15%-20% reduction in left ventricular function. Valvuloplasty maintains the interaction of ventricular muscle structures and the pulley mechanism of the valve, whereas both are disrupted during valve replacement.

According to different working mechanisms, annuloplasty can be divided into direct annuloplasty and indirect annuloplasty.。

(1) Indirect shaping

Indirect annuloplasty involves placing a device between the coronary sinus ostium and the distal coronary sinus, then tightening the coronary sinus with the help of a connector to reduce the mitral annulus. However, due to the risk of compressing the circumflex artery and causing coronary artery obstruction, it was not further promoted in clinical practice after being approved in 2009.

(2) Direct Molding

Direct annuloplasty, on the other hand, reduces mitral regurgitation by implanting a device within the heart chamber that reduces the annulus or directly implanting a forming ring.

Currently, both types of annuloplasty are only used for patients with functional mitral regurgitation.

Traditional annuloplasty rings are mostly fixed in shape, unable to adapt to the dynamic changes of the heart during different cardiac cycles, resulting in limited repair effectiveness. To overcome this limitation, after years of research and development, Medtronic has introduced SimuForm^®Mitral Valve Annuloplasty Ring. By simulating the dynamic changes of the natural annulus, this product can better adapt to the physiological needs of the heart, thereby improving repair outcomes and long-term prognosis for patients.

# Product Introduction

▲SimuForm®Mitral Annuloplasty Ring

SimuForm^®Mitral Valve Annuloplasty Ring at2024Year4Officially launched in China in the month，Its unique“Soft in the Front, Hard in the Back”The semi-rigid design and dynamic shaping capability are the core highlights of this product.

Unlike traditional fixed-shape forming rings,SimuForm^®Forming RingAble to intelligently adjust shape with the cardiac cycle：During cardiac systole, the annuloplasty ring presents a saddle shape to enhance leaflet coaptation and reduce stress; during cardiac diastole, the annuloplasty ring transitions to“O”Shape,Optimize hemodynamics. The design of this dynamic change makes it a revolutionary tool in the field of valve repair, better simulating the physiological function of the natural annulus, effectively correcting anatomical abnormalities, while maximizing the preservation of native valve function. It is especially suitable for complex cases such as degenerative diseases.

SimuForm^®The size range is 24-40mm.。

Design Principle

SimuForm^®The design inspiration comes from an in-depth study of the physiological function of the natural annulus. Normal heart valves undergo complex morphological changes during the cardiac cycle to meet the demands of blood flow. During systole, the valve needs to close tightly to prevent blood regurgitation; during diastole, the valve needs to open to ensure smooth blood inflow into the ventricle. Traditional fixed-shape annuloplasty rings cannot meet this dynamic demand, andSimuForm^®The forming ring, with its unique design, can intelligently adjust its shape to better simulate the function of the natural annulus.

Technical Advantages

SimuForm^®The technical advantages of the molding ring are mainly reflected in the following aspects:

Dynamic Shaping Capability:SimuForm^®Capable of intelligently adjusting its shape during the cardiac cycle, presenting a saddle shape during systole and transforming during diastole.“O”Shape. This dynamic change can better adapt to the physiological needs of the valve, reduce valve stress, and optimize hemodynamics.
“Soft in the front, hard in the back”Design:The anterior part of the forming ring is made of soft material, while the posterior part is made of hard material. This design allows for better adaptation to the anatomical structure of the annulus, while providing sufficient support to ensure the stability and functionality of the valve.
Adapt to Complex Lesions:SimuForm^®Suitable for a variety of complex lesions, including degenerative and rheumatic lesions. Its design effectively corrects anatomical abnormalities of the valve while maximizing the preservation of native valve function and reducing postoperative complications.

Clinical manifestations

The patient who underwent surgery this time is a46-year-old female, since2025Year1Symptoms of chest tightness and fatigue after activity appeared, and was diagnosed after examinationMitral Valve Prolapse with Severe Regurgitation. Despite undergoing3 After months of standardized anti-heart failure medication treatment, the patient's heart continued to enlarge, and the regurgitation did not significantly improve, ultimately leading to the choice of surgical treatment.

Director Pan Yuchen's team, after a comprehensive evaluation of the patient's condition,2025Year5Month27The patient underwent surgery under general anesthesia and cardiopulmonary bypass.Mitral Valve+Tricuspid Valve Combined Repair。

Intraoperatively, regarding the patient's posterior mitral valve leafletP3Area and Posterior JunctionC2For the complex condition of regional mixed prolapse combined with chordae tendineae rupture, the team adopted adjustable chordal technology to repair the prolapsed leaflets and simultaneously implantedSimuForm^®The annuloplasty ring completes the annular reconstruction, and the enlarged tricuspid annulus is managed concurrently.

Intraoperative Esophageal Ultrasound and Postoperative1Monthly follow-ups all showed ideal repair outcomes.。

▲Preoperative Assessment

▲Postoperative Minimal Reflux

# The First Case of Implantation in GuangxiClinical Significance

“Mitral valve repair technology is becoming an important development direction in the treatment of valvular heart disease in China, with the number of surgeries and their proportion increasing year by year.”Director Pan Yuchen pointed out,SimuForm^®The introduction will further enhance the precision of repair surgeries and long-term outcomes.

The First Case in Guangxi This TimeSimuForm^®The successful application of the forming ring not only fills the technical gap in this field in the region, but also accumulates valuable experience for subsequent promotion.

SimuForm^®The introduction of the forming ring is a major technological innovation in the field of mitral valve repair. Its dynamic shaping ability“Soft in the front, hard in the back”Designed to better simulate the physiological function of the natural annulus, effectively correct anatomical abnormalities, and maximize the preservation of native valve function. This innovative design not only improves the success rate of surgery but also reduces the occurrence of postoperative complications, significantly enhancing the long-term prognosis of patients. Compared with traditional valve replacement surgery, mitral valve repair surgery is less invasive, allows for quicker recovery, and preserves native valve function.SimuForm^®The dynamic design further enhances the repair outcome, reduces the occurrence of postoperative complications, and significantly improves the patient's quality of life.

# About Medtronic

Medtronic(Medtronic, NYSE: MDT) was founded in 1949, with its headquarters in Minneapolis, Minnesota, USA. It is a global leading medical technology company with over 95,000 employees.

Medtronic's innovative solutions have expanded to more than 70 key disease areas, committed to providing lifelong treatment options for patients with chronic conditions. Every second, two patients worldwide benefit from Medtronic's medical technology or therapies.

Medtronic's main businesses includeCardiovascular, Medical Surgery, Neuroscience, and DiabetesFour business blocks, includingThe highest proportion is cardiovascular.。What Does Medtronic Sell? A Comprehensive Overview of the Cardiovascular Product Line

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