Shanghai-based cryoablation treatment specialist Cryofocus Medtech (Shanghai) Co., Ltd’s in-house developed Cryofocus RDN System, a cryoablation renal denervation product, has obtained breakthrough therapy designation (BTD) status from the US FDA for use in refractory hypertension.
Regulatory Milestones and Innovations
The Cryofocus RDN System, the first of its kind globally, previously passed novel medical device special review by the National Medical Products Administration (NMPA). Professor Ge Junbo, a CAS academician with Zhongshan Hospital, led this team to complete the world’s first in vivo operation using the Cryofocus RDN System with deep hypothermia in 2015. This product, featuring 360° circular ablation, complete nerve injury, precise ablation location, and small endothelial damage, can cover the effective ablation depth, positioning it as a significant advancement in the treatment of refractory hypertension.-Fineline Info & Tech
