Shanghai, China, 20 December 2021 — MicroPort NeuroTech Limited (MicroPort NeuroTech™) has published the outcomes of the study ‘Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System (PESS),’ a pre-market clinical trial for the Bridge® Rapamycin Target Eluting Vertrbral Stent System (Bridge®, previously known as Firehorus). The results were published in an article titled “Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients with Symptomatic Extracranial Vertebral Artery Stenosis” in Frontiers in Neurology, an authoritative journal in the field of neurology.
The premarket study of PESS is a prospective, multicenter and single-arm clinical trial led by Prof. Zhongrong Miao from the Cerebrovascular Disease Center of Beijing Tiantan Hospital Affiliated to the Capital Medical University. In addition, Prof Zhongrong Miao also contributed to the study in collaboration with a number of other renowned neurointerventional experts and their teams, including Prof. Kangning Chen, Prof. Jie Shua, Prof. Jieqing Wan, Prof. Zhenwei Zhao and Prof. Wei Wu.
The Bridge® Rapamycin Target Eluting Vertrbral Stent System is the first drug-eluting stent designed for symptomatic vertebral artery stenosis in China. When compared to bare-metal stents, Bridge®’s single-sided, grooved, drug-eluting stent allows for precise and targeted drug release. In addition, its low drug load and up to 95% bare stent surface area can reduce the incidence of in-stent stenosis associated with bare stents and minimise the negative effects of drugs on endothelialization. The clinical safety and efficacy of Bridge® for the treatment of vertebral artery stenosis were verified in this study and mark a significant development.
The PESS study published the angiographic follow-up at 6 months and the final clinical follow-up at 12 months: there were 101 subjects with symptomatic vertebral artery stenosis enrolled for interventional therapy, and a total of 104 target lesions were successfully stented at the vertebral artery stenosis. In real-life clinical practice, the risk of in-stent restenosis in vertebral artery therapy is usually higher than 30%. Prior to the trial for Bridge®, the target in-stent restenosis rate at 6 months was set at 20.5%. Results from the trial showed that the post-operative in-stent restenosis rate of Bridge® at 6 months was 5.9% in the full analysis set (FAS), and 3.7% in the per protocol set (PPS). The upper limit of post-operative restenosis at 6 months being much lower than the target demonstrates that the risk of post-operative in-stent restenosis was significantly reduced after the implantation of Bridge®.
These positive results, along with the publishing of the PESS study of Bridge® confirms its safety and efficacy, and indicates that the clinical effectiveness of Bridge® has been recognized by leading neurological experts. Since obtaining NMPA approval for marketing on December 17, 2020, Bridge® has been widely acknowledged by specialists for its clinical performance.
Prof. Zhongrong Miao noted, “The launch of Bridge® provides a reliable solution for the treatment of vertebral artery stenosis. The pre-market clinical data shows the superior performance of this stent. I believe it will become a bridge to ensure free-flowing blood in the vertebral artery, just as its name implies.”
About MicroPort NeuroTech Limited
MicroPort NeuroTech Limited is a subsidiary of MicroPort Scientific Corporation (stock code: 00853.HK). Founded in 2012, MicroPort NeuroTech™ is a high-end medical device company focused on neuro-intervention, that provides a range of neuro-interventional products to treat a variety of brain conditions. MicroPort NeuroTech™ remains close to clinical need and develops cutting-edge products with innovation and quality as the top priority. In the future, MicroPort NeuroTech™ will maintain insight into cutting-edge technologies and trends in the field of neurology and will continue to promote innovation, research and development, and enhance academic exchange at home and abroad, to provide patients with inclusive, total medical solutions.