Tonghe Litai Supports Synaptic Medical's Cryoablation System in Securing NMPA Approval
Synaptic Medical
Cardiovascular Medical Device R&D Developer
On January 20, 2025, the NMPA website showed that the National Medical Products Administration (NMPA) approvedSynaptic Medical Technology(Beijing)Co., Ltd.'s "Cryosurgical Ablation System"Innovative Product Registration Application.
This product, composed of a main unit, a coaxial fluid connector tube, and a connecting cable, is designed for use with the company’s balloon-type cryoablation catheter. Utilizing dual pressure and flow control technology, it achieves stable balloon pressure during inflation and ablation by real-time monitoring and control of refrigerant flow and balloon pressure. This technology effectively reduces the risk of balloon displacement caused by pressure fluctuations during pulmonary vein occlusion and ablation, and is used for treating adult patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
Nordica Cryoablation System
Note: Image source: Siyu MedTech
The animal experiments for this product have been successfully completed at BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD.From the design of animal experimental protocols, the approval of animal ethics, the operation of animal experiments, the postoperative care of laboratory animals, the analysis of pathological results, to the writing of preclinical evaluation reports, all are implemented by the professional technical team of BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD according to standardized SOP procedures, ensuring the standardization of the experimental process, the authenticity of experimental data, and the reliability of experimental results. Going forward, BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD will also actively cooperate with customers in conducting clinical medical training to accelerate the speed of clinical promotion after product certification and market launch.
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Tonghe LItai
BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD, located in Zhongguancun Medical Device Park, operates in a 7,500-square-meter facility. It is the only large-animal experimental technology service platform in China with a barrier-level environment primarily for pigs. It has been named the "Medical Device Collaborative Innovation and Common Service Technology Platform" by the Beijing Municipal Science and Technology Commission.
Since its establishment, BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD has been committed to building a strongly connected technology service platform centered on experts, enhancing the platform's professional service capabilities, creating an ecosystem for experts, enterprises, and research institutions, and playing the role of an incubator for scientific research projects.
As a comprehensive service platform for preclinical animal testing of barrier-grade medical devices in China, Tonghe Litai consistently adheres to strict SOP procedures to serve every innovative medical device product. From the design of the experimental protocol to the specific implementation of the experiment, stringent controls are applied to ensure the standardization of the experimental process, the authenticity of the experimental data, and the reliability of the experimental results. Since its establishment, BEIJING TONGHELITAI BIOTECHNOLOGY CO., LTD has issued more than 600 preclinical evaluation reports for medical devices that comply with NMPA registration requirements.
BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD always adheres to the principle of being customer demand-oriented. According to customer needs, it can fully assist enterprise products in different stages such as early incubation research, biocompatibility evaluation, preclinical evaluation, clinical trials, and registration. For potential problems and shortcomings, it provides reasonable suggestions and optimization plans to help products obtain certification as soon as possible while saving costs and time. Meanwhile, after product certification, BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD will also provide clinical promotion training through various channels, offering full-process services to help products quickly gain clinical application.
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