#Germany #Frankfurt #Heart Health #Valgen Medtech #DragonFly™

Valgen Medtech's Breakthrough in Heart Valve Treatment

In a significant advancement for cardiac health, Valgen Medtech recently announced that its patented transcatheter mitral valve repair system, DragonFly™, has received CE marking from the European Union for the treatment of functional mitral regurgitation (FMR). This critical approval positions DragonFly™ at the forefront of minimally invasive heart valve repair, marking it as the first Chinese-origin device to obtain such endorsements for both degenerative mitral regurgitation (DMR) and FMR indications.

Understanding Functional Mitral Regurgitation

Mitral regurgitation is a common heart valve disorder that can severely affect patients, particularly those with underlying heart failure conditions. FMR is notably challenging to manage, leading to daunting clinical dilemmas for healthcare providers. In recent years, international consensuses have evolved to establish optimal treatment strategies for managing this complex condition.

European Guidelines Boosting Transcatheter Repair

In 2025, the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) jointly published updated guidelines that elevated transcatheter edge-to-edge repair (TEER) to a Class I recommendation for treating selected patients with ventricular functional mitral regurgitation (vFMR). This endorsement signals the growing recognition of TEER as a viable treatment option, promoting further investment in innovative technologies like DragonFly™.

Asia-Pacific Consensus and Treatment Pathways

Following the European guidelines, the Asia-Pacific Society of Cardiology (APSC) released a consensus statement in April 2026. This report provides standardized treatment pathways and long-term management strategies for symptomatic patients suffering from moderate to severe functional mitral regurgitation, reinforcing the role of TEER therapies in contemporary cardiac care.

Robust Clinical Evidence Supporting DragonFly™

The safety and efficacy of the DragonFly™ system are backed by extensive clinical evidence emerging from various multi-center studies conducted in Asia, Europe, and globally. Notable trials such as DragonFly-DMR, DragonFly-FMR, and DragonFly-EU have demonstrated the device's robust performance and patient outcomes. During the recent CSI Frankfurt 2026 conference, Valgen Medtech presented one-year follow-up results from the pivotal DragonFly-DMR EU study, which provided promising data on the safety, durability, and clinical performance among elderly patients at high surgical risk for DMR.

Impressive Outcomes After One Year

After one year of follow-up, the results showed that 100% of patients maintained mitral regurgitation severity at ≤2+ (moderate or less). Furthermore, the primary efficacy endpoint—a composite measure defined as the absence of all-cause mortality, repeat mitral valve procedure, and mitral regurgitation >2+—was achieved in 86.7% of patients. The procedure showcased an impressive device implantation success rate of 97.4%, with many patients requiring only one clip for effective repair.

Functional Improvement and Cardiac Remodeling

In addition to procedural success, the study reported that 100% of patients improved to NYHA Class I or II within 30 days post-procedure, and these improvements persisted throughout the year. The findings also included evidence of favorable reverse cardiac remodeling, a crucial dynamic in heart recovery.

Global Expansion and Commitment to Innovation

To date, DragonFly™ has secured regulatory approvals in 15 countries and regions, with ongoing clinical usage and commercialization in key international markets, including Latin America and Southeast Asia. Valgen Medtech remains steadfast in its dedication to innovation driven by clinical needs, aiming to expand access to safe, effective, and minimally invasive treatment options for patients globally. With the recent CE approval, DragonFly™ is set to transform the landscape of cardiac care and improve the quality of life for countless patients battling functional mitral regurgitation worldwide.