NoYA™ RF Interatrial Shunt System Achieves First Global Enrollment in Pivotal Clinical Trial

Hangzhou, March 12, 2021 /PRNewswire/ -- On March 10, 2021, Hangzhou Noya Medtech Co., Ltd. (hereinafter referred to as "Noya"), a subsidiary of Deno Medical, independently developed the first interatrial shunt system in China-- NoYA™ The radiofrequency interatrial shunt system has completed the global first enrollment in its registrational clinical study. The procedure was performed by Professor Kong Xiangqing’s team at the First Affiliated Hospital of Nanjing Medical University, marking the first interatrial shunt procedure for a registrational clinical trial in China.

Group Photo of Surgical Team After Surgery

The incidence of chronic heart failure is continuously rising, posing a major global public health challenge. Among these cases, heart failure with preserved ejection fraction (HFpEF) has an incidence rate of 1%–5.5% and accounts for 40%–70% of all heart failure patients, with suboptimal responses to pharmacological therapy. Interatrial shunting has become a globally recognized surgical intervention for the treatment of heart failure.

NoYA™ Radiofrequency Interatrial Shunt System, independently developed by Noya Medtech, is the world’s first product utilizing radiofrequency energy without any implants, offering a novel therapeutic option for heart failure patients, particularly those with HFpEF, by artificially creating an “interatrial septal shunt channel” to establish left-to-right shunting between the atria. Compared to other products under development, the NoYA™ Radiofrequency Interatrial Shunt System involves no permanent implants, thereby avoiding the risk of thrombosis. NoYA™ creates a shunt aperture in the interatrial septum through a combination of stent support and radiofrequency energy. The device is fully retrievable, allowing for multiple deployments and retrievals, and features an adjustable shunt diameter to accommodate diverse procedural requirements.

Adjustable Interatrial Shunt System and Radiofrequency Ablation Device

Postoperatively, Professor Kong Xiangqing’s team highly evaluated the device’s performance. As the first interventional device in China designed for the treatment of heart failure, the NoYA™ Radiofrequency Interatrial Shunt System demonstrated favorable clinical performance. The absence of permanent implants and the adjustable aperture size are expected to provide greater clinical benefits to patients. Its ease of use and short learning curve will facilitate the widespread adoption of interatrial shunt procedures. We look forward to the NoYA™ Radiofrequency Interatrial Shunt System bringing innovation to the field of heart failure treatment.

“The R&D head of Noya stated, ‘In the future, the NoYA™ radiofrequency interatrial shunt system will collect more clinical data in registration clinical trials to provide evidence-based medical support for procedural refinement and product iteration, offering a new treatment option for HFpEF patients worldwide who do not respond to conventional therapies, so that more heart failure patients can benefit sooner.’”