Zhengzhou, China, 27 January 2022 — MicroPort NeuroTech Limited (MicroPort NeuroTech™) recently announced that it has enrolled the first patient in the PROMISE Study, a pre-market clinical study for the Rebridge® Intracranial Visualized Stent (Rebridge®), bringing the product into the clinical enrollment phase.
The PROMISE Study is a prospective, multicenter, open, non-inferiority, randomized, controlled clinical study co-led by Prof. Jianmin Liu of Shanghai Changhai Hospital and Prof. Sheng Guan of the First Affiliated Hospital of Zhengzhou University. The first patient was enrolled by Prof. Guan's team. This study is designed to assess the safety and efficacy of Rebridge® in the treatment of intracranial aneurysm, with the primary endpoint being the successful aneurysm occlusion rate at 12 months postoperatively. Secondary endpoints include evaluation metrics, such as the complete aneurysm occlusion rate at 12 months postoperatively.
Prof. Guan of the First Affiliated Hospital of Zhengzhou University commented, "As the acronym of this study implies, we can see the 'promise' of MicroPort NeuroTech™’s Rebridge®, and recognize the potential for it to become one of the leading coil embolization assisting stents for intracranial aneurysm treatment. We believe that our team will be able to validate and deliver this promise to patients in China and around the world.”
Prof. Liu of Shanghai Changhai Hospital also recognised the milestone of the Rebridge® study, stating, “The first patient enrollment in the clinical trial for Rebridge® marks a step forward for Chinese-made medical devices. I would like to congratulate the research team and hope they will complete the PROMISE project with high quality.”
Rebridge® is a new coil embolization assisting stent developed by MicroPort NeuroTech™ for the treatment of intracranial aneurysm. It features a densely braided, fully radiopaque mesh that ensures full visualization. Compared with other stents that only have several radiopaque wires serving as marker wires, Rebridge® can help physicians precisely position the stent, to achieve optimal vessel wall apposition after stent deployment.
Mr. Zhiyong Xie, President of MicroPort NeuroTech™, said, “We are pleased to see that the performance of Rebridge® is being recognized by clinicians. This brings MicroPort NeuroTech™ one step closer to its goal of providing a total medical solution for stroke patients. We believe that through the efforts of all investigators, the PROMISE study will provide scientific evidence for Rebridge® and promote the product launch for the benefit of more patients.”
About MicroPort NeuroTech Limited
MicroPort NeuroTech Limited is a subsidiary of MicroPort Scientific Corporation (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. In the future, MicroPort NeuroTech™ will invest more resources in innovation and development to provide more quality and innovative solutions for cerebrovascular and neuro interventions for doctors and patients at home and abroad.