CSI Frankfurt 2026: DeJin Medical Unveils DragonFly™ European Clinical Outcomes and Real-World Evidence

Jun 06, 2026 16:00 CST Updated 16:00

Valgen Medtech

Minimally Invasive Interventional Device Developer

June 3-6, 2026, Frankfurt, Germany.

At the Cardiovascular Interventions (CSI) Frankfurt 2026 conference, a premier global event in structural heart disease interventions, Valgen Medtech showcased its DragonFly™ transcatheter valve repair system. The company not only presented comprehensive achievements in mitral and tricuspid valve intervention but also leveraged rigorous European multicenter clinical data to leave a profound mark of Chinese innovation within the global framework of atrioventricular valve interventional diagnosis and treatment.

From R&D iteration in the laboratory to clinical practice in the operating room, and further to academic resonance on international stages, Valgen Medtech transcends technological and geographical boundaries. As a pioneer, it continues to explore the infinite possibilities in the field of transcatheter atrioventricular valve repair.

One-Year Follow-Up Results of the DragonFly-EU DMR Clinical Study

Officially Announced

Professor Georg Nickenig, Head of the Heart Center at University Hospital Bonn, announced the one-year follow-up data from the DragonFly–DMR EU clinical study. As the first multicenter European study of a Chinese transcatheter mitral valve repair system, these data fill a critical gap in the clinical evidence chain for Chinese medical devices in Europe.

This is a prospective, single-arm, multicenter clinical study designed to evaluate the safety and efficacy of DragonFly™ in treating patients with symptomatic moderate-to-severe degenerative mitral regurgitation (DMR) who are at high surgical risk. The study enrolled and treated a total of 39 patients across eight centers in Europe. The mean age of the subjects was 80.5 ± 4.4 years, with 33.3% being female. All enrolled subjects had mitral regurgitation (MR) greater than 3+, and 66.7% of the patients presented with severe (4+) regurgitation prior to the procedure.

The treatment success rate at 1 year post-procedure was 86.7%, with DragonFly™ successfully achieving the prespecified primary efficacy endpoint. The proportion of subjects with MR < 2+ reached 100% at 1 year, with all subjects experiencing a reduction in regurgitation severity to below moderate levels, thereby demonstrating the durability of DragonFly™ in correcting DMR.
The immediate postoperative procedural success rate and device implantation success rate in the study were both 97.4%. In 66.7% of subjects, repair was completed with the implantation of a single mitral valve clip, significantly reducing surgical trauma and procedure time in elderly patients. The 30-day major adverse event rate was as low as 5.3%. These results further demonstrate that DragonFly™ offers excellent maneuverability and safety.
The 1-year postoperative follow-up results demonstrated significant improvements in both cardiac function and quality of life. At 30 days post-surgery, the proportion of subjects with NYHA functional class I/II reached 100% and remained stable through 12 months. The follow-up findings clearly supported positive reverse remodeling of the left atrium and left ventricle, anatomically confirming the procedure’s role in slowing the progression of heart failure.

Based on global clinical feedback, Valgen Medtech continues to drive technological iterations. At this conference, Professor Georg Nickenig also disclosed the clinical research progress of the next-generation system, DragonFly™ M2.

This iteration embodies Valgen Medtech’s R&D philosophy of “clinical needs driving technological evolution,” ensuring that its products consistently deliver highly predictable performance in complex and dynamic clinical scenarios.

Real-World Case Sharing

A Universal Power Transcending Geographical Boundaries

If prospective clinical trials validated the “ideal efficacy” of the product under strictly selected conditions, then real-world clinical feedback from overseas truly tested the “broad adaptability” of DragonFly™. At the conference, Professor Ismail Ateş, Head of the Heart Center at ASV Yaşam Hospital in Antalya, Turkey, shared real-world clinical application experiences and case studies of the DragonFly™ system in Turkey.

Professor Ismail Ateş provided a detailed analysis of five severe cases of mitral/tricuspid regurgitation that were complex and posed significant anatomical challenges. This patient population presented with complex clinical backgrounds, encompassing various high-risk factors such as uremic cardiomyopathy, chronic renal failure, ischemic cardiomyopathy with a history of prior coronary artery bypass grafting (CABG), and severe right ventricular dysfunction, thereby classifying them as high-risk candidates for surgical intervention.

DragonFly™ demonstrates excellent clinical outcomes:

In all five high-risk cases, postoperative residual regurgitation was reduced to MR < 2+, with excellent transvalvular pressure gradients, achieving a 100% procedural success rate. All reported cases had zero mortality, zero device-related complications, and zero major adverse events during hospitalization.

These valuable overseas clinical application experiences intuitively demonstrate the practical capability of DragonFly™ in addressing complex mitral/tricuspid valve lesions, providing robust evidence of its unique clinical advantages as a “universal, comprehensive atrioventricular valve repair system.”。It successfully transcends geographical and individual patient differences, consistently delivering deterministic treatment protocols.

DragonFly™, developed in response to clinical needs and validated through rigorous R&D and global multicenter studies, has established its clinical value in complex, high-risk patients. Every international academic exchange and every piece of real-world data will serve as nourishment for the advancement of the atrioventricular valve intervention field.

Valgen Medtech will continue to collaborate with global clinical experts to jointly explore and cooperate, driving transcatheter repair of atrioventricular valves to new heights.

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