On July 5, 2024, "Cryoablation System" independently developed by Artechmed (Shanghai) was approved as a National Innovative Medical Device in China.Medical Device Products`, obtained the certification issued by the National Medical Products Administration (NMPA)`Class III Medical DevicesRegistration Certificate, Approved for Marketing.
The approved cryoablation instrument consists of a main unit, gas extension tube, andBalloon CatheterComposed of tail wires, it will be used in conjunction with the company's cryoballoon for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation in adult patients.
Compared with similar domestic and foreign products already on the market in China, the product's use of "adjustable cooling capacity" and "rewarming alert" technologies is a pioneering innovation. The "adjustable cooling capacity" technology can monitor freezing temperatures in real time, reducing damage to adjacent tissues while ensuring the effectiveness of cryoablation treatment. The "rewarming alert" technology helps mitigate clinical and procedural risks such as myocardial injury caused by premature balloon retraction and difficulty in balloon sheathing.After the cryoablation system was approved for marketing,ArtechmedWill be held in conjunction withOther components of the cardiac cryoablation system, one of the first to initiate the formal clinical application of the "cryo+pulse" dual-platform layout with the cryoballoon ablation product, aim to bring the company's "simplified ablation" concept to fruition as soon as possible.Benefit a large number of patients with atrial fibrillation.
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 has dual product technology platforms in Cryoballoon Ablation (CBA) and Pulsed Field Ablation (PFA), as well as dozens of core independent intellectual property rights. The key team members all have extensive experience working in well-known medical device companies, with rich expertise in the research and development, production, clinical development, commercialization, and company operations of products in the fields of electrophysiological diagnosis and treatment, cardiovascular and cerebrovascular interventions, cryoablation, and active medical devices.
