Valgen’s DragonFly TMVR System Receives CE Mark Approval for FMR Indication

June 26, 2026—Valgen Medtech, based in Hangzhou, China, recently announced that its DragonFly transcatheter mitral valve repair system has received European CE Mark approval for the treatment of functional mitral regurgitation (FMR).

In April 2025, the device received European approval for degenerative mitral regurgitation (DMR), noted Valgen. 

The company advised that DragonFly has received regulatory approvals in 15 countries and regions with routine clinical use and commercial adoption underway in key international markets, including Latin America and Southeast Asia.

According to Valgen, the DragonFly system is supported by clinical evidence generated through a series of multicenter studies across Asia, Europe, and other international regions, including the DragonFly-DMR, DragonFly-FMR, and the DragonFly-EU pivotal trials.

On June 8, Valgen announced that 1-year follow-up results from the DragonFly–DMR EU pivotal trial were presented at CSI Frankfurt 2026.

As summarized in the company’s press release, the DragonFly device demonstrated favorable safety, durability, and clinical performance in elderly patients with severe DMR who were at high surgical risk.

At 1-year follow-up, the device demonstrated the following:

• Sustained MR reduction was achieved with 100% of patients maintaining MR severity at ≤ 2+ (moderate or less).
• A composite primary effectiveness endpoint (defined as freedom from all-cause mortality, mitral valve reintervention, and MR > 2+) was achieved in 86.7% of patients.
• Both the device implantation success rate and procedural success rate reached 97.4%, while 66.7% of patients required just a single clip.

Additionally, 100% of patients had improved to New York Heart Association class I or II by 30 days postprocedure, which was maintained through 1 year. The findings also demonstrated favorable cardiac reverse remodeling, stated Valgen.