Antec Medical's Disposable Intracardiac Mapping Catheter Receives NMPA Approval
Artechmed
Medical Device and Equipment Developer
On August 5, Artechmed's self-developed "Single-Use Intracardiac Mapping Catheter" product obtained the Class III medical device registration certificate issued by the National Medical Products Administration (NMPA) and was approved for marketing in China.
The disposable endocardial mapping catheter approved this time is a circular mapping catheter, used for recording pulmonary vein potential signals within the heart, and is suitable for atrial fibrillation electrophysiological examinations.
In addition to the standard models (15mm and 20mm), the newly approved disposable intracardiac mapping catheter also includes a 25mm size. The larger loop mapping catheter, when used with a short-tip cryoballoon catheter, offers significant advantages in identifying abnormal potentials in large pulmonary veins and accurately determining TTI.In addition, the decapolar circular mapping catheter can more accurately identify pulmonary vein potentials, reduce far-field potential interference, help clinicians determine the endpoint of cryoablation, avoid under-ablation or over-ablation, and further improve the safety and efficiency of atrial fibrillation cryoablation procedures.
The approval and market launch of the disposable intracardiac mapping catheter will facilitate the formal clinical application of Artechmed's cardiac cryoablation system, meeting the "simplified ablation" clinical needs in China's atrial fibrillation ablation treatment field.
Artechmed was founded in 2017, with its headquarters located in the Zhangjiang International Medical Park within Zhangjiang Science City. It focuses on innovative solutions for cardiac electrophysiology diagnosis and treatment. The company has developed a dual-product technology platform comprising Cryoballoon Ablation (CBA) and Pulsed Field Ablation (PFA), along with dozens of core proprietary intellectual properties.
The core members of the company all have extensive work experience in well-known medical device enterprises and possess rich experience in R&D, production, clinical development, commercialization, and company operations for products in fields such as electrophysiological diagnosis and treatment, cardiovascular and cerebrovascular interventions, cryoablation, and active medical devices.
Source: Artechmed
