Three innovative medical devices in Shanghai were approved for marketing, independently developed by local companies
2024-08-07
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Recently, the National Medical Products Administration approved the registration applications of three innovative products, including the "Balloon Cryoablation Catheter" of Shanghai Antec Medical Technology Co., Ltd., the "Renal Artery Radiofrequency Ablation Device" and the "Disposable Mesh Renal Artery Radiofrequency Ablation Catheter" of Shanghai Meiliweiye Medical Technology Co., Ltd. The Shanghai Municipal Drug Administration revealed on August 6 that this year, a total of 3 domestic Class 1 innovative drugs, 3 imported innovative drugs, and 6 Class III innovative medical devices were approved for marketing in Shanghai.
The "Balloon Cryoablation Catheter" approved by Shanghai Antec Medical Technology Co., Ltd. Image provided by Shanghai Food and Drug Administration
The "Balloon Cryoablation Catheter" of Shanghai Antec Medical Technology Co., Ltd. consists of a balloon cryoablation catheter and a manual retractor, and is used in conjunction with a specific cryoablation device to treat drug-refractory, recurrent, and symptomatic paroxysmal atrial fibrillation in adult patients. The "32mm large balloon" and "8mm short head" design used in this product can stably control the refrigerant flow rate, effectively control the freezing temperature, and can be close to the pulmonary vein orifice to effectively collect pulmonary vein potentials, thereby ensuring the cryoablation effect. Compared with similar domestic and foreign products listed in China, this technology is pioneering. The launch of this product can further meet my country's clinical needs in the field of paroxysmal atrial fibrillation treatment.
Shanghai Meiliweiye Medical Technology Co., Ltd. has been approved for the "renal artery radiofrequency ablation device" and "disposable mesh renal artery radiofrequency ablation catheter"
The "renal artery radiofrequency ablation instrument" of Shanghai Meiliweiye Medical Technology Co., Ltd. consists of a main unit, a foot switch, a main unit connection cable, a neutral electrode connection cable and a power cord. The "disposable mesh renal artery radiofrequency ablation catheter" consists of a basket bracket, an ablation electrode, a protective sheath, a handle and a connector. The above two products can be used in conjunction with each other to assist in the treatment of refractory hypertension and hypertensive patients with drug intolerance. The disposable mesh renal artery radiofrequency ablation catheter has six spirally arranged electrodes, which can effectively improve the ablation efficiency. The basket-shaped design ensures that blood flow is not blocked during ablation, which is original both domestically and internationally. The temperature, impedance measurement and feedback control algorithm used by the renal artery radiofrequency ablation instrument make the operation easier. The launch of this product is conducive to the clinical application and promotion of radiofrequency ablation technology, which can further reduce clinical treatment costs and benefit more hypertensive patients with refractory hypertension and drug intolerance.
Official website screenshot
Official website screenshot
During the period from R&D application to approval for marketing of the above-mentioned innovative products, the Yangtze River Delta Branch of the National Medical Products Administration's Medical Device Technical Review and Inspection Center has provided "one-on-one, zero-distance" consulting and guidance services to innovative companies on many occasions through a dedicated coaching mechanism for innovative products; the Shanghai Municipal Drug Administration has included the products in the recommended pre-service scope, and the Municipal Medical Device Evaluation Center, Municipal Medical Device Institute, and the Biomedical Product Registration Guidance Service Workstations in Pudong, Xuhui and other districts have proactively provided services to collaboratively solve the bottlenecks and difficulties encountered by companies in the process of product R&D, testing, registration verification and other links, helping companies to avoid detours.
Shanghai's drug administration department will continue to improve policy supply and innovation service capabilities, continuously improve the "one list, two optimizations, and three linkages" service mechanism, formulate a list of key research and development products and projects, and carry out graded and classified service guidance in accordance with the principles of "early intervention, dedicated personnel, full-process tracking, and professional guidance"; give full play to the frontier feel of the district-level bio-pharmaceutical product registration guidance service workstation, and actively explore and cultivate innovative products through a combination of "municipal-level database construction + district surveys"; set up a special window platform for medical device services to track and ensure key projects, with dedicated personnel to serve the specific demands of enterprises and guide the resolution of difficult and complicated problems; implement "one product, one enterprise, one policy" for key varieties in critical periods, improve the pertinence and effectiveness of services, and strive to achieve the "acceleration" of supporting the listing of innovative drugs and devices in the city, actively serve the high-quality development of the bio-pharmaceutical industry, and ensure the safety of patients' use of drugs and devices.
Zou Juan, senior reporter of The Paper
(This article is from The Paper. For more original information, please download the "The Paper" APP)
