The Tubridge Vascular Reconstruction Device from MicroPort was granted Green Channel status to fast track for China Food and Drug Administration (CFDA) approval on 3 February 2016.
According to the company, this will significantly shorten the approval time, benefiting more Chinese patients earlier than expected.
Tubridge was studied in a prospective, randomised, controlled clinical trial with participation of 12 neurovascular intervention centres 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 embolisation technique.
The study protocol was published in BMC Neurology, a journal of the prevention, diagnosis and management of neurological disorders.