Zhenyi Medical Announces First-in-China "Straight-Line" Mitral Valve Clip NeoNova® with Positive One-Year Clinical Data

Mitral regurgitation is the most common valvular heart disease in China, affecting approximately 27% of people aged 60 and above. About 7.5 million patients require interventional treatment, including 5.5 million with severe MR. The 5-year mortality rate for untreated severe MR patients is as high as 50%. However, 50% of these patients are unable to undergo surgery due to old age, impaired cardiac function, or multiple comorbidities. Currently, only about 40,000 mitral regurgitation surgeries are performed annually in China, accounting for just 0.5% of the number of patients requiring treatment for MR. Therefore, the development of transcatheter mitral valve intervention technology is of great significance, providing new treatment options for patients who cannot tolerate surgery, improving patient outcomes, and enhancing treatment accessibility to meet the growing clinical demand.

Study Design

NeoNova® Pivotal Trial is a prospective, single-arm, multi-center study designed to evaluate the safety and effectiveness of the NeoNova® system in treating patients with moderate-to-severe or severe degenerative mitral regurgitation (DMR). Conducted across 23 research centers in China, the study commenced on April 26, 2022, concluded on March 21, 2024, and enrolled a total of 123 patients.

The primary efficacy endpoint (composite endpoint) was defined as the treatment success rate at 1 year post-surgery: no death, no surgical mitral valve-related surgery due to mitral valve dysfunction, and mitral regurgitation ≤2+ at the 1-year follow-up. The secondary efficacy endpoints included immediate procedural success rate, incidence of surgeries due to mitral valve dysfunction, NYHA functional class I/II rate, and rehospitalization rate for cardiovascular disease. Safety endpoints encompassed major adverse events (MAE) rate, all-cause mortality, and cardiac mortality.

Main inclusion criteria: Patients with clinical symptoms of heart failure and transthoracic echocardiography-confirmed moderate to severe or severe organic mitral regurgitation (i.e., MR ≥3+), NYHA functional class II-IV, who are at prohibitive or high risk for surgical intervention (STS score for surgical valve replacement ≥8 or STS score for surgical valve repair ≥6, presence of ≥2 frailty indexes, presence of ≥2 organ dysfunctions), have anatomy suitable for transcatheter mitral valve edge-to-edge repair, and have feasible femoral venous access and atrial septal puncture conditions.

Main Exclusion Criteria: Severe coronary artery stenosis requiring revascularization or having undergone coronary intervention within 30 days; echocardiography indicating the presence of thrombus, vegetations, or masses in the heart; moderate or severe (≥3+) aortic valve stenosis or regurgitation, and other cardiac conditions requiring surgical treatment; unsuitable mitral valve anatomy for MitraClip placement, including but not limited to severe mitral valve leaflet and annulus calcification, insufficient mitral valve orifice area, history of previous mitral valve surgery, rheumatic mitral valve disease, etc.; left ventricular end-diastolic diameter (LVEDD) >7.0 cm, left ventricular ejection fraction (LVEF) <20%; uncontrolled active infection or active bacterial endocarditis.

Research Results

The average age of subjects enrolled in the NeoNova® study was 70.79±6.75 years, with proportions of MR 3+ and MR 4+ subjects being 12.2% and 87.80%, respectively, and the proportion of NYHA Class III/IV heart function subjects was 83.73%.

NeoNova® study results show that the immediate device implantation success rate was 100%; the average operating time for clip implantation was 84.36 minutes; the number of implanted clipsAn average of 1.4±0.5; implant positions A1P1 and A3P3 account for 43.1%, and A2P2 accounts for 45.5%., Other (junction or mixed cases) account for 11.4%, demonstrating the effectiveness and superiority of NeoNova® design in treating complex cases.

The primary efficacy endpoint of the NeoNova® study showed a 92.68% treatment success rate at 1 year post-surgery, with 79.66% of patients having MR ≤1+ and 96.62% having MR ≤2+. Secondary efficacy endpoints revealed that 94.92% of patients were in NYHA Class I/II heart function, the cardiovascular-related rehospitalization rate was 11.38%, and the surgical rate due to mitral valve dysfunction was 1.63%. For safety endpoints, the incidence of MAE, all-cause mortality, and cardiac mortality at 1 year post-surgery were 9.76%, 2.44%, and 0.81%, respectively.

NeoNova® Mitral Valve Clip System Demonstrates Excellent Safety and Efficacy in Treating Patients with Degenerative Mitral Regurgitation. One-year follow-up results show a significant increase in the proportion of patients with MR≤2+ and NYHA functional class improvement to Grade I/II, indicating its sustained effectiveness in improving symptoms and quality of life.

NeoNova® Mitral Valve Clip, as the first "elastic self-locking" mitral valve clip in China, its exclusive "rigid parameters" ensure that the clip automatically adapts to the strength of the valve, minimizing the risk of leaflet tearing. Meanwhile, its "linear" design effectively reduces the risk of chordae entanglement and increases the probability of intraoperative chordae disentanglement. The extreme 180° bending capability of its controlled bending segment enhances the operator's performance limit, achieving a 43.1% implantation rate in complex anatomical structures such as A1P1/A3P3, greatly improving adaptability for complex cases.

In addition, the 10mm large clip has the potential to solve prolapse above 15mm with a single clip. Reducing the number of implanted clips in wide prolapse lesions can effectively decrease operation time. Elastic locking provides better leaflet protection and effective control of the orifice area.

In the future, the NeoNova® system will further evaluate its long-term safety and effectiveness through real-world clinical research, continuously expanding the global accessibility of transcatheter mitral regurgitation interventional treatment, providing more patients with safe and effective treatment options.

Professor Wang Yan concluded: "The NeoNova® pivotal trial, as an original Chinese study, has achieved very positive results, validating the clinical safety, efficacy, and excellent performance of the NeoNova® Transcatheter Mitral Valve Clip System independently developed in China. This is also inseparable from its multiple innovative design advantages. From my personal experience of use, the NeoNova® system is simple and convenient to operate, with easy and precise orientation adjustment. Its 'linear' elastic locking design effectively prevents and resolves intraoperative tendon entanglement, offering better leaflet protection. It performs particularly well in complex situations such as treating commissural lesions, reducing the number of clip implants required and greatly improving the efficiency of mitral valve disease treatment. Once again, congratulations on the approval and clinical application of the NeoNova® Transcatheter Mitral Valve Clip System in China, and I look forward to it bringing good news to a large number of Chinese patients with mitral regurgitation."

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