Shanghai, China, 02 April, 2024 — Recently, the post-market clinical study (Trace-IA) results for the Tubridge™ Flow Diverter (Tubridge™), developed by MicroPort® NeuroTech™, were officially published in the neurosurgery journal Clinical Neuroradiology under the title, "Clinical Outcomes On Tubridge Flow Diverter in Treating Intracranial Aneurysms: a Retrospective Multicenter Registry Study".
The Trace-IA clinical study is a retrospective, multicenter registry study conducted in China to evaluate the efficacy of Tubridge™ in treating intracranial aneurysms. Led by Professor Jianmin Liu from the Cerebrovascular Disease Center at Changhai Hospital, the study involved collaboration with prominent neurointervention centers across China. This included The First Affiliated Hospital of Zhengzhou University (Principal Investigator: Professor Sheng Guan), Huashan Hospital affiliated to Fudan University (Principal Investigator: Professor Xiangyu Gu), Beijing Tiantan Hospital, Capital Medical University (Principal Investigator: Professor Ming Lyu), Henan Provincial People’s Hospital (Principal Investigator: Professor Tianxiao Li), Zhongnan Hospital of Wuhan University (Principal Investigator: Professor Wenyuan Zhao), The First Affiliated Hospital, Sun Yat-sen University (Principal Investigator: Professor Tiewei Qi), Xiangya Hospital Central South University (Principal Investigator: Professor Weixi Jiang), and Zhujiang Hospital of Southern Medical University (Principal Investigator: Professor Chuanzhi Duan). The study encompassed 235 clinical research centers and enrolled a total of 1,281 patients.
The aim of the study was to assess the safety outcomes of the Tubridge™ in treating intracranial aneurysms. The primary endpoint was the 12-month event-free survival rate, defined as the occurrence of morbidity (spontaneous rupture, intraparenchymal hemorrhage, ischemic stroke, and permanent cranial neuropathy) or death.
The study's findings revealed a 12-month post-treatment event-free survival rate of 92.84%, with neurological morbidity and death rates at 5.4% and 2.8%, respectively. Ischemic stroke, the most common complication following flow-diverting procedures, occurred at a rate of 4.2% in this study. Additionally, the rates of cranial neuropathy and intraparenchymal hemorrhage were both 0.3%, while the rate of spontaneous rupture bleeding was 0.5%. Overall, the Trace-IA study results robustly validate the efficacy and safety of Tubridge™ in treating intracranial aneurysms.
Tubridge™ offers a comprehensive range of sizes, with diameters ranging from 2.5mm to 6.5mm and lengths up to 45mm, accommodating the vast majority of aneurysm patients, especially those with large or giant aneurysms. Moreover, Tubridge™ is woven from nickel-titanium material, which possesses superelasticity and shape memory properties, ensuring good wall apposition and vascular compliance for intracranial tortuous vessels, thus facilitating endothelial cell growth and aneurysm healing.
Since its launch in China in March 2018, the clinical application of Tubridge™ has surpassed 10,000 cases. Moving forward, MicroPort® NeuroTech™ remains committed to prioritizing clinical applications and patient needs, aiming to provide higher-quality and more accessible, comprehensive treatment solutions for cerebrovascular diseases.
About MicroPort® NeuroTech™
MicroPort® NeuroTech™ (MicroPort NeuroTech Limited; HKEX: 2172) , an associated company of MicroPort® (MicroPort Scientific Corporation; HKEX: 00853), is committed to the research and development of high-end medical devices in the field of neurological interventional treatment with solutions that currently support over 100 cerebrovascular stenting procedures every day. In the future, MicroPort® NeuroTech™ will continue investing more resources in innovation and development to provide more high-quality and innovative cerebrovascular and neuro intervention solutions for doctors and patients.
More information is available at www.medneurotech.com.