Recently, the innovative product "Renatus® Transcatheter Aortic Valve System" of Beijing Balance Medical Technology Co., Ltd. is approved by China NMPA.

This product consists of a bioprosthetic valve, a delivery device, a balloon dilatation catheter, a catheter sheath kit, a crimping device, and an inflation pump. The product features a balloon-expandable stent structure. It is indicated for patients with symptomatic, calcified, severe degenerative aortic valve stenosis who are evaluated by a heart team and deemed unsuitable for conventional surgical valve replacement, and who are 70 years of age or older. Under the guidance of medical imaging equipment, the bioprosthetic valve can be implanted through either a long or short delivery system, depending on the patient's specific access route, into the aortic annulus, replacing the diseased aortic valve and improving the stenosis at the affected site, thereby enhancing cardiac function and meeting the clinical needs of different access routes.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.