
Cardiovascular Medical Device R&D Developer

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.
This 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.
Pre-Review of Clinical Trial Protocols for Innovative Products
