Xinuopu Medical Technology (Beijing) Co., Ltd. Receives NMPA Approval for Cryoablation Console and Disposable Balloon Cryoablation Catheter

(Source: China Food and Drug Administration Network)

Recently, the National Medical Products Administration approved the registration application for the cryoablation system and the disposable balloon-type cryoablation catheter from Synaptic Medical Technology (Beijing) Co., Ltd.

The cryoablation system consists of a cryoablation system main unit and a touch screen. The single-use balloon-type cryoablation catheter is composed of a balloon-type cryoablation catheter, a coaxial fluid connector tube, and a connecting cable. The cryoablation system is used in conjunction with the single-use balloon-type cryoablation catheter for the treatment of adult patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

The product uses a compliant, adjustable-diameter balloon, which is a first in China, and is expected to improve the success rate of pulmonary vein occlusion.

The drug supervision and administration department will strengthen the post-marketing supervision of the aforementioned products to protect patients' safety in using medical devices.