Synaptic Medical's Domestically Pioneering Cryoablation System Gains NMPA Approval
Synaptic Medical
Cardiovascular Medical Device R&D Developer
On March 31, 2026, the National Medical Products Administration (NMPA) announced the approval and market launch of "Cryotherapy System and Single-Use Balloon Cryoablation Catheter."
Recently, the National Medical Products Administration approvedSynaptic Medical Technology(Beijing)Co., Ltd.Si'sCryogenic Ablation System, Disposable Balloon Cryoablation CatheterRegistration Application.
The cryoablation instrument consists of the main unit and a touch screen.
The disposable balloon-type cryoablation catheter consists of a balloon-type cryoablation catheter, a coaxial fluid connector tube, and a connecting cable.
The Cryoablation System, used in conjunction with a disposable balloon-type cryoablation catheter, is indicated for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation in adult patients.
Notably, the balloon of this product adoptsBalloon with Adjustable Compliance Diameter, belonging toFirst of Its Kind in ChinaCompared with traditional fixed-diameter balloons, the adjustable design can better adapt to the pulmonary vein anatomy of different patients, which is expected to improve the success rate of occlusion and reduce the difficulty of surgery.
Cryoballoon ablation for atrial fibrillation is an interventional treatment technology that has rapidly developed in recent years. Previously, the Chinese market was mainly dominated by imported brands. The recent approval of Synaptic Medical signifies another step forward for domestically produced enterprises in the field of atrial fibrillation treatment.
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