Shanghai, China, 09 August 2021 – The last procedure of the IMPACT Study, a propsective, multicenter post-marketing surveillance study using the Tubridge® Vascular Reconstruction Device (Tubridge®), was recently performed at the First Affiliated Hospital of Zhengzhou University. The procedure marked the successful enrollment of all 200 subjects in the study since the first operation was completed on December 16, 2019.
The IMPACT study, co-led by the People’s Hospital of Henan Province, Changhai Hospital Affiliated to the PLA Naval Medical University, and Beijing Tiantan Hospital affiliated to the Capital Medical University, involves 15 research centers, including the First Affiliated Hospital of Zhengzhou University, Zhujiang Hospital of Southern Medical University, the People’s Hospital of Jiangsu Province, and the Second Affiliated Hospital of Nanchang University, to evaluate the safety and efficacy of Tubridge®.
Professor Tianxiao Li, Director of the Interventional Treatment Center of the People’s Hospital of Henan Province, said, “With the increasing number of neurointerventionists in China, neurointervention research capability has improved significantly. The pre-market PARAT study for Tubridge® was the first Randomized Controlled Trial (RCT) in the field of neurointervention in China. Not only did the study pioneer the clinical trial, but it also laid the foundation for further scientific research. The completion of the IMPACT clinical study with full subject enrollment will provide stronger medical evidence for the real-world application of devices. ”
Designed for large and giant aneurysms that are difficult to treat in clinical practice, Tubridge® is able to alter the flow pattern within the aneurysm by applying the principles of hemodynamics, which allows endothelial cells to grow along the stent-graft and gradually repair the Aneurysmal neck, thus eliminating the ‘ticking bomb’ in the brain.
Professor Jianmin Liu, Director of the Cerebrovascular Disease Center at Changhai Hospital affiliated to the PLA Naval Medical University, said, “I believe that the IMPACT study will provide high-level scientific evidence to further understand the efficacy and safety of flow diverters in the treatment of small intracranial aneurysms.”
It is reported that almost 4 out of 10 people above 25 years old in China are at risk of stroke, and at least 1 out of 5 deaths are caused by stroke. An intracranial aneurysm is an abnormal bulge that occurs in the wall of an intracranial artery, and patients are at an increased risk of mortality and incapacitation upon its rupture.
Tubridge® is the first neurointerventional product that was granted access to the NMPA Green Path, a special approval procedure for innovative medical devices, and is currently the only domestically produced blood flow diverter developed in China. Over the past three years since its launch, Tubridge® has achieved a six-month cure rate of 75%, far outperforming the 24% achieved with conventional imported spring coil and stent therapy1.
MicroPort® NeuroTech has been committed to the innovative research and development of high-end devices in the field of neurointervention since its establishment, and has been continuously improving the product portfolio of stroke intervention. The company’s products are now available in more than 1,000 hospitals nationwide and have been used in the treatment of over 70,000 patients. In the future, MicroPort® NeuroTech will continue to pursue innovation and strive to become a provider of inclusive total stroke solutions.
About MicroPort® NeuroTech
MicroPort NeuroTech Co., Ltd. (MicroPort® NeuroTech) 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 and provides a full range of neuro-interventional products to treat brain disease.
1. Data provided by business