Shanghai, China – Tubridge™ Vascular Reconstruction Device ("Tubridge™"), an innovative product of MicroPort NeuroTech (Shanghai) Co ("MicroPort® NeuroTech"), was granted Green Channel status to fast track for China Food and Drug Administration ("CFDA") approval on February 3. This will significantly shorten the approval time, and therefore benefiting more Chinese patients earlier than expected.
Tubridge™ was studied in a prospective, randomized, controlled clinical trial with participation of 12 leading neurovascular intervention centers in China. The results of the trial demonstrated the safety and efficacy of this innovative device in the treatment of large or giant cerebral aneurysms, and were significantly better than the traditional stent-assisted coil embolization technique. The study protocol was published in BMC Neurology, a journal of the prevention, diagnosis and management of neurological disorders.
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. 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. Larger aneurysms are the most dangerous, with high aneurysmal rupture rate, high treatment cost, complex operating procedure and high recurrence rate.