Shanghai, China, December 23 2020 — The Bridge® Vertebral Drug-Eluting Stent, developed by Shanghai MicroPort NeuroTech Co., Ltd. (MicroPort® NeuroTech), received a registration certificate issued by China’s National Medical Products Administration (NMPA) on December 17, 2020 for the treatment of symptomatic vertebral artery stenosis.
According to the latest Global Burden of Disease Study (GBD) data, the incidence of ischemic stroke in China has been increasing, from 1.12 per 1,000 people in 2005 to 1.56 per 1,000 in 2017. Patients with posterior circulation ischemic stroke account for 25-40% of those who suffered from ischemic stroke, and 9-33% of them have symptoms of stenosis or occlusion at the beginning of the vertebral artery.
The approved Bridge® Vertebral Drug-Eluting Stent features a unique drug delivery design in which the drug is loaded only inside the grooves on the stent surface facing the vessel wall, allowing for faster endothelialization and reduced thromboembolic events and restenosis.1
The approval further completes the neurointerventional product line of MicroPort® NeuroTech. “The Bridge® Vertebral Drug-Eluting Stent, which has completed the NMPA special approval procedure for innovative medical devices, will deliver improved treatment options for patients with symptomatic vertebral artery stenosis,” said Zhiyong Xie, President of MicroPort® NeuroTech. “MicroPort® NeuroTech will persist in innovative research and development, and strive to make innovative treatment options more accessible to patients to cure their brain conditions and continue their wonderful lives.”
In clinical practice, stenting has become the primary treatment for vertebral artery stenosis as it improves cerebral blood flow with immediate effect, preventing stroke recurrence and reducing ischemic injury in the posterior circulation. However, the placement of bare metal stents tends to cause a high incidence of restenosis partly due to anatomy. Drug-eluting stents, on the other hand, cause a much lower rate of restenosis, recurrence and retreatment in the treatment of vertebral artery stenosis, albeit there can be drug side-effects.2
The pre-market clinical trial of the Bridge® Stent was led by Beijing Tiantan Hospital, with an additional six clinical centers participating across China. The study data showed a 98% success rate of Bridge® Stent implantation and a 3.7% incidence of in-stent restenosis at six months after the operation. Among the long-term follow-up cases, no in-stent restenosis was found on DSA review four years after stent implantation, demonstrating the long-term effectiveness of the Bridge® Stent.
About MicroPort® NeuroTech
“Attention to detail” and “persistence in innovation” are in the DNA of MicroPort® NeuroTech, an innovative company in the field of neurointerventional therapy. Since 2002, MicroPort® NeuroTech has dedicated its efforts to neurointerventional therapy for 18 years. During the period, it has brought the unique APOLLO™ intracranial balloon expanding stent and WILLIS® intracranial stent graft systems as well as the innovative Tubridge® revascularization devices to the market. Thousands of hospitals have benefited from these products and together with doctors, these products have saved or rebuilt more than 50,000 patients’ lives.
References:
1 Circulation. 2001 Jun 12;103(23):2816-21
2 J Neurointerv Surg. 2016 Aug;8(8):770-4