DragonFly™ Transcatheter Mitral Valve Clip System: China's First Domestically Developed Transfemoral Venous TEER Device Completes Nationwide Initial Implantations

Mar 11, 2024 10:07 CST Updated 10:07

Valgen Medtech

Minimally Invasive Interventional Device Developer

Source of the article:Heart NotCome;Editor: Bai Xiaofei

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently,Cardiovascular Hospital Affiliated to Xiamen UniversityInterventional Team for Structural Heart DiseaseValgen MedtechIndependently DevelopedDragonFly™ Transcatheter Mitral Valve ClipSystem SuccessTreating a patient with end-stage heart failure and severe mitral regurgitation (MR4+),Completion of the First National Implants of DragonFly™ Post-Market in China。

In November 2023, DragonFly™ was officially approved for marketing by the National Medical Products Administration (NMPA).China's First Approved Domestically Produced Mitral Valve Clip Product via Femoral Venous Approach。

# Patient Details

The patient is currently 79 years old, with a long-termRepeated hospitalization due to heart failure, cardiac function continues to deteriorate even after full optimization of drug therapy,Surgical treatment of valve carries extremely high risks., after evaluation by the hospital's cardiac team, it is proposed to performTranscatheter Mitral Valve Edge-to-Edge Repair Treatment, in order to reduce regurgitation and improve cardiac function. However, due to end-stage cardiac changes, severe left atrial enlargement, a short posterior mitral valve leaflet, and extremely poor cardiac function,The surgery is extremely difficult.。

Echocardiography Indicates：LVD 63mm, LA 70mm EF 60%, bi-atrial and left ventricular enlargement,Severe mitral regurgitation (MR4+), moderate to severe tricuspid regurgitation, Moderate to severe pulmonary hypertension.

Anterior Leaflet Length: 2.4cm, posterior leaflet length: 1.0cm, orifice area: 5.62cm², lesion width: 1.5cm.

# Surgical Strategy and Procedure

The difficulties of this surgery are as follows:：

(1) The left atrium was severely enlarged to 83mm×104mm, and the interatrial septum was deformed, increasing the difficulty of puncture;

(2) Maximum width of mitral regurgitation disease 15mm, more than 2 mitral clips;

(3) The posterior leaflet of the mitral valve is relatively short, with a gap of 3.7mm between the anterior and posterior leaflets during systole; grasping may cause high tension on the valve leaflets, making it more challenging.

After discussion by Professor Wang Yan's team, it was decided to place one long-wide clip in area 2 first, and then decide whether to place a second mitral valve clip based on the regurgitation situation.

During the surgery,First, implant 1 MitraClip in zone 2, after release, regurgitation decreased to 2+., the transvalvular pressure gradient is 3mmHg, and the L side of the first clamp is implantedInsert the second mitral valve clip,Immediate postoperative mitral regurgitation decreased to 1+., the transvalvular pressure gradient was 4mmHg, with significant results.

Postoperative echocardiography of the patient indicated:Mitral regurgitation reduced to trace amounts。

▲Post-release imaging of the valve clip

# Future Trends in Mitral Valve Treatment

Mitral Regurgitation (MR) is the most common heart valve disease. Severe Mitral Regurgitation (MR) occurs in up to a quarter of patients with heart failure and reduced ejection fraction. If left untreated, itThe mortality rate within 3 years is 40-50%, and the rate of heart failure readmission (HFH) within 5 years is 90%.。With the increase of age, the incidence of mitral regurgitation significantly rises, with nearly half of the cases presenting high-risk factors for surgical intervention. In 2003, the world's first transcatheter mitral valve edge-to-edge repair (TEER) was performed, and as of 2022Global TEER Cumulative Implant Volume Exceeds 200,000 Cases。

According to "Clinical Pathway for Transcatheter Mitral Valve Edge-to-Edge Repair in China (2022 Full Text Version)",Approximately 7.5 million MR patients in China require interventional treatment., The incidence of MR significantly increases with age. It is 0.3% in the population aged 35-50, 0.9% in those aged 51-64, and 2.2% in individuals aged ≥65. In the population over 65 years old, the incidence of MR in moderate to severe heart valve disease is as high as 19.1%.More than 2/3 of patients cannot undergo surgical treatment due to risk factors such as old age and complications, with a 5-year mortality rate as high as 50%.。

The key to the development of transcatheter mitral valve treatment devices lies in technological innovation.TEER products that have received CE/FDA approval are currently only from two companies:Abbott's MitraClip and Edwards' PASCAL，Both adopt the femoral vein approach.。Looking at the product iterations of overseas giants, we can summarize thatThe Three Major Trends in Technological Innovation in This Field：

（1）Surgical access route transitions from transapical to transfemoral vein., significantly reducing invasive procedures and effectively decreasing the incidence of severe postoperative adverse events. This allows more interventional cardiologists to manage device operations while providing treatment opportunities for a greater number of patients at high surgical risk.

（2）From Complex to User-Friendly Devices, improve the operational friendliness of the device, which is conducive to clinical promotion.

（3）From Single Surgery to Combined Surgery: The Application of Combined Instruments, providing diversified solutions for patients with complex mitral valve disease while enhancing treatment efficacy and durability.

# DragonFly™ Transcatheter Mitral Valve Clip System

▲DragonFly™ Transcatheter Mitral Valve Clip System

DragonFly™ by Valgen Medtech in collaboration with the Second Affiliated Hospital of Zhejiang University School of MedicineAcademician Wang Jian'an TeamWith the National Engineering Research Center for Biomaterials at Sichuan UniversityAcademician Zhang Xingdong's TeamClose cooperation，After nearly a decade of research and developmentThe journey has been conceived and supported by the National "14th Five-Year Plan" Key Research and Development Program.

DragonFly™ Features the Following Four Innovative Designs`, enabling safer and more effective clamping, adapting to a wider range of patients, with overall operation being more intuitive and convenient, and treatment outcomes precise and accurate.`

（1）Extensible Central Occlusion Net with Clamp Arm Stepless Self-Locking, mechanical clipping, ensures stable leaflet capture while reducing leaflet tension and minimizing damage to the leaflets. It also decreases central residual regurgitation while reducing postoperative transvalvular pressure gradients.

（2）4 Specifications of Clamps`, can match the anatomical structures of different leaflets, providing more options for patients with mitral regurgitation caused by various lesions and anatomical variations.`

（3）Independent Grasping`, which enables unilateral capture, can improve the success rate and efficiency of surgeries for complex cases.`

（4）Precision-controlled delivery system, with a visualized and articulated scale operating system, combined with a unique three-stage adjustable tube design, allowing for more precise and convenient operation.

# Clinical Research Results

DragonFly™ successfully performed the first implant surgery in China in 2020, inClinical Trials Conducted at 27 Centers Across China. Clinical data showsThe system has good operability as well as long-term safety and effectiveness.。

From May 2021 to January 2022, the DragonFly-DMR trial enrolled and treated 120 patients in China. Follow-up data shows,The immediate postoperative surgical success rate and device implantation success rate for 120 patients were both 99.2%. The treatment success rate at 12 months postoperative was 87.5%.(95% confidence interval: 80.1%, 92.2%). Follow-up results at 12 months post-operation showed significant improvement in cardiac function and quality of life for the patients. This confirmatory clinical trial demonstrated significant treatment outcomes.Successfully achieved the pre-set primary efficacy and safety endpoints。

During the surgery, 52.5% of subjects in the DragonFly™ device group successfully received one valve clip, while 42.5% successfully received two valve clips. The mean mitral transvalvular pressure gradient (TMPG) immediately post-operation and at 12 months was 2.88±1.34mmHg and 3.19±1.38mmHg, respectively.DragonFly™ Performance Data and the Latest Clinical Trial Results of Overseas Similar Products MitraClip and PASCALThere is considerable comparability.。

At the same time, the 12-month postoperative follow-up results showed that the patients' cardiac function and quality of life were significantly improved. The proportion of NYHA Class I/II subjects increased from 32.4% at baseline to 93.6% at 12 months (P<0.001), and the Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved by 30.64±18.35 points relative to baseline (P<0.001).

DragonFly-DMR Trial Results Show,The DragonFly™ system demonstrates good safety, efficacy, and controllability in treating organic mitral regurgitation., offering a better treatment option for DMR patients at high surgical risk.

About Valgen MedtechHealthcare

Valgen Medtech Co., Ltd. (hereinafter referred to as Valgen Medtech) focuses onInterventional Treatment Field of Structural Heart Disease. Founded in Hangzhou in 2015, by the end of 2023,The company has applied for more than 500 patents worldwide, of which over 150 have been granted.. Independently developedThree Innovative Products Pass the NMPA's Special Review Process for Innovative Medical DevicesThe multiple interventional treatment devices represented by the Dragon series will also greatly enrich the clinical options in the field of structural heart disease treatment in China.

DragonFly™ Transcatheter Mitral Valve Clip System, asChina's First Self-Developed Transfemoral Venous Approach Edge-to-Edge Repair Product, which passed the NMPA's special review process for innovative medical devices in March 2021, and was officially approved by the NMPA for marketing in China on November 29, 2023. The product is supported by the "14th Five-Year Plan" National Key Research and Development Program of the Ministry of Science and Technology. In addition, currently available products include Pujiejie™ Medical Radiation Protection Screen, Magpie™ Balloon Dilation Catheter, DragonPath™ Atrial Septal Puncture System, and Firework™ Guidewire Series, among others.

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