Suzhou Jiecheng Medical Technology Co., Ltd. Overview
Suzhou Jiecheng Medical Technology Co., Ltd. (“Jiecheng Medical”) was established on 8 September 2009 and is headquartered in BioBAY, Suzhou Industrial Park, jiangsu, China. In February 2022, the company became a wholly owned subsidiary of Jenscare Scientific (健适医疗) and was integrated into its Structural Heart Disease Division. Recognized as a national “Little Giant” enterprise, Jiecheng specializes in the R&D, manufacturing, and commercialization of minimally invasive transcatheter heart-valve systems targeting aortic valve disease.
Core Business and Key Technologies
Jiecheng Medical focuses on Class III implantAble cardiovascular devices. Its proprietary technologies include:
J-Valve® Transcatheter Aortic Valve System – the first self-positioning bioprosthesis deliverable via transapical or transfemoral approACH.
Unique “3-D positioning” technology enables implantation without Rapid ventricular pacing and effectively treats pure aortic regurgitation (non-calcified annulus), a condition not addressed by other TAVR devices.
Supporting portfolio includes delivery systems (transapical introducer kit, J-Valve loader) and a next-generation low-profile valve currently under NMPA review (submitted September 2024).
Market Position and Flagship Product
J-Valve® is the only TAVR system approved by the NMPA for both aortic stenosis and regurgitation, with more than 3,000 implants performed since 2017 across 180+ centers in china. Key milestones include:
2017 – First Chinese TAVR approved under NMPA “Innovative Green Channel”.
2018 – Health Canada Special Access approval; > 100 patients treated in Canada.
2019 – FDA Compassionate Use approval (IDE pending) for use in the U.S.
2024 – CE Mark dossier submitted for review in Europe.
Production and Regulatory Updates
In 2024, Jiecheng completed a major manufacturing expansion, adding a Class-B cleanroom, an automated leaflet-assembly line, and 100% in-process imaging-based quality control. Regulatory developments include:
2023 – Completion of pivotal trial for the new-generation low-profile valve (NCT05412345).
2024 – NMPA registration dossier submitted; CMDE review ongoing.
2025 – Planned FDA IDE submission for pivotal U.S. clinical study.
Contact Information
Address: Building C21, BioBAY, 218 Xinghu Street, Suzhou Industrial Park, Suzhou 215123, Jiangsu, P. R. China
Phone: +86 512 6317 9688
Keywords: Suzhou Jiecheng Medical Technology, J-Valve, TAVR, transcatheter aortic valve replacement, aortic regurgitation, minimally invasive valve therapy
