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Zylox-Tonbridge completes patient enrollment in the PEVENSEY study for Zynlastic™ peripheral venous stent system
On July 12, 2021, ZYLOX-TONBRIDGE (2190.HK) announced that the Company has successfully completed enrollment in the PEVENSEY study. The PEVENSEY study is a prospective multicenter randomized controlled clinical trial designed to gain the China National Medical Products Administration (NMPA) approval for its Zynlastic™ peripheral venous stent system (“Zynlastic”). The Company plans to make the registration submission for Zynlastic™ with National Medical Products Administration (“NMPA”) in early fourth quarter of 2022 after 12-month follow-up, which is approximately six months ahead of the schedule previously disclosed in the prospectus of the Company dated June 22, 2021 (i.e. the second quarter of 2023), and expects to receive NMPA approval for Zynlastic™ in 2023.
The trial enrolled 161 patients at 14 sites comparing Zynlastic stent with Zilver Vena Venous Stent from Cook Medical to evaluate the effectiveness and safety of Zynlastic in the treatment of patients with Iliac vein compression syndrome (IVCS). The patients were randomly selected to receive either the Zynlastic stent or the Zilver Vena stent, and patient follow-ups of 6 months and 12 months following implant are required by the protocol. The patient enrollment of the PEVENSEY study was completed within 10 months. No stent restenosis or revascularization was observed for the patients who have received 6 months follow-up so far.
“Zynlastic is the first venous stent developed and made in China, the performance and quality of which fully surpasses imported products,” said Prof. Yu ZHAO, Director of Vascular Surgery Center of the First Affiliated Hospital of Chongqing Medical University, and principal investigator of the PEVENSEY study. “This will become a classic case of R&D engineers and doctors cooperating to develop new products and innovate the leading-edge technologies.
Zynlastic ™ peripheral venous stent system developed and manufactured by Zylox-Tonbridge is composed of a unique three-segment construction stent and the novel controlled-release delivery system. The stent is pre-mounted in the flexible catheter (delivery system) and delivered to the compressed vessel section near the bifurcation of the inferior vena cava through iliac vein to expand the compressed section and maintain the vessel lumen.
Zynlastic stent featuring the three-segment design: powerful close-cell oblique distal end, flexible middle section and proximal anchoring section is designed for the treatment of symptomatic venous outflow obstruction in the iliac veins, which is often caused by Iliac vein compression syndrome (IVCS).
Iliac vein compression syndrome (IVCS) refers to a syndrome in which the iliac vein is compressed by the iliac artery, resulting in changes such as intraluminal adhesion, luminal stenosis, or occlusion of the vein, which causes obstruction of the iliac vein flow and a range of clinical symptoms. The number of newly diagnosed IVCS patients reached 690,000 in China in 2019, and will reach nearly 2,000,000 by 2030.
The Zynlastic™ peripheral venous stent system is an investigational device in clinical research, limited by applicable law to investigational use and not available for sale.
Zylox-Tonbridge is a leading developer and manufacturer of medical devices in China. Headquartered in Future Technology City, Hangzhou, ZYLOX-TONBRIDGE Medical Technology Co., Ltd. is composed of ZYLOX Peripheral Vascular Intervention BU and TONBRIDGE Neurovascular Intervention BU. Since its establishment, ZYLOX-TONBRIDGE has launched a series of medical devices in peripheral and neuro vascular fields.