Shanghai, China – MicroPort NeuroTech (Shanghai) Co., Ltd. ("MicroPort® NeuroTech"), a subsidiary of Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), recently gained the approval of China Food and Drug Administration ("CFDA") for its in-house developed Tubridge® Vascular Reconstruction Device ("Tubridge®"). It is the fifth product of MicroPort® that obtained the CFDA approval through Green-Path, a fast-track approval process offered by CFDA for innovative medical devices.
Tubridge® is the first China-developed flow diverting stent that has obtained CFDA approval in China. It is designed for the treatment of large and giant cerebral aneurysm. The device cures the cerebral aneurysm by effectively diverting the blood flow based on the hemodynamics, reducing the impact of blood flow to the cerebral aneurysm, and enabling the endothelial cells to grow along the stent struts and gradually repair aneurysmal neck.
Since the release of the results of International Subarachnoid Aneurysm Trial in 2002, interventional treatment has experienced rapid development and has become one of the major treatment methods of intracranial aneurysm. However, when it comes to treating large and giant cerebral aneurysm, traditional stent-assisted coil embolization technique has its limitations such as complex procedure, mass effect and high reoccurrence rate.
In 2005, MicroPort® started to develop Tubridge® and successfully broke many technological hurdles such as densely meshed wire braids. Tubridge® was selected as one of the projects in the National Key Technology R&D Program for China's 12th Five-Year Plan. It is also the first flow diverting stent used in the clinical setting, researched via a hemodynamic approach, and studied in a randomized clinical trial, as well as the first neurovascular device obtained CFDA Green-Path status in China.
A cerebral aneurysm is a weak or thin spot on a blood vessel in the brain that balloons up and fills with blood. It is the main cause of subarachnoid hemorrhage, and is the third top killer among acute cerebrovascular diseases, after acute ischemic stroke and hypertensive cerebral hemorrhage. The bulging aneurysm can put pressure on a nerve or surrounding brain tissue. Aneurysms can later burst and bleed into the brain, causing serious complications or even death. Large and giant aneurysms are the most dangerous, with high aneurysmal rupture rate, high treatment cost, complex operating procedure and high recurrence rate. The CFDA approval of Tubridge® will definitely enable more domestic intracranial aneurysm patients to benefit from this innovative technology.
Zhiyong Xie President of MicroPort® NeuroTech said: "MicroPort® NeuroTech is dedicated to developing innovative solutions for cerebrovascular diseases. We will provide high quality medical devices by constant innovation to benefit patients with cerebrovascular disease."