On August 6, 2024, Artechmed, a company based in China, independently developed the "Balloon Cryoablation Catheter"National Innovative Medical Device Product, obtained the certification issued by the National Medical Products Administration (NMPA)"Class III Medical DevicesRegistration Certificate, Approved for Marketing.
The balloon-type cryoablation catheter approved this time will be used in conjunction with the already approved cryoablation instrument for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation in adult patients.
When used in conjunction with a cryoablation instrument, this product fully demonstrates the innovative features of Artechmed's cardiac cryoablation system, namely "adjustable cooling capacity" and "rewarming alerts." These features help reduce damage to adjacent tissues while ensuring effective cryoablation treatment, minimizing clinical and procedural risks such as myocardial injury caused by premature balloon retraction and difficulty in balloon sheathing. Additionally, the product’s "large balloon" design enables effective ablation of complex pulmonary vein structures, including common pulmonary veins and pulmonary vein vestibules. Its "short-tip" design improves the success rate of pulmonary vein potential acquisition. This product technology is pioneering compared to similar products both domestically and internationally.After the balloon-type cryoablation catheter was approved for marketing, Artechmed has completed the pairing of cryoablation equipment and cryoablation consumables. It is about to launch the formal clinical application of the cardiac cryoablation system, which will further meet the diverse "simplified ablation" clinical needs in the field of atrial fibrillation ablation treatment in China.
Artechmed was founded in 2017, with its headquarters located in the International Medical Park of Zhangjiang Science City, Shanghai, focusing on innovative solutions for cardiac electrophysiology diagnosis and treatment. The company already hasCryoballoonCryoballoon Ablation (CBA) and Pulsed Field Ablation (PFA) Dual-Product Technology Platform, Dozens ofCore Independent Intellectual Property RightsThe core team members all have extensive work experience in well-known medical device companies and possess rich experience in product development and production, clinical development, commercialization, and company operations in fields such as electrophysiological diagnosis and treatment, cardiovascular and cerebrovascular interventions, cryoablation, and active medical devices.
