talos™ gained cfda green-云顶国际

shanghai, china – on september 27, talos™ thoracic stent graft system ("talos™"), self-developed by microport endovascular (shanghai) co., ltd. ("microport® endovascular"), was approved to enter the special green-path by china food and drug administration ("cfda"), which is rapid-track of review and approval procedure for innovative medical devices. the green-path will significantly expedite the approval time and meanwhile it demonstrated the recognition of chinese government authorities in talos™.

the traditional treatment of aortic dissection is to replace aorta in lesion segment by open surgery, which has high mortality rate and high incidence rate of complications due to large trauma. thoracic endovascular aneurysm repair ("tevar") features small incision, short operative time, and fast postoperative recovery, resulting in easier operation and lower mortality rate. thus, tevar has gradually taken place of the traditional open surgery to become the preferred choice of treating type b aortic dissection. but subject to the current technology, differences in pathophysiology of the disease and individual anatomical, the treatment using stent graft also has its own limitations: the lesion segment of aortic dissection is usually very long involving descending aorta and even abdominal aorta, however the existing thoracic stent grafts are often not long enough to completely cover the lesions, failing to open the distal true lumen and keep the blood of whole aorta vascular flowing smoothly after primary tear occlusion. but, if using long stent graft in the tevar, it will affect the blood supply of thoracic spinal cord and lumbar spinal cord, increasing the risk of spinal cord ischemia after the surgery. microport® endovascular's talos™ extents the covered length of the sg (maximum 260mm) to open the distal true lumen and ensure the patency of the aorta, and at the same time innovatively adopts micropores design at the distal end of the sg to ensure the distal branch vessels (e.g., intercostal arteries) patency so as to reduce the incidence of spinal cord ischemia.

cfda green-path on china's innovative medical devices is critically important approach introduced by the government authority to encourage the innovations of medical devices and promote the application of new technologies in the healthcare industry. innovative medical devices entering green-path procedure will receive preferential review process by food and drug administrations to assign special personnel to process the submissions, which will significantly accelerate the approval process and product launch in market. other than talos™, three products of microport® endovascular also entered the cfda green-path, including castor® branched aortic stent graft system ("castor®"), reewarm® ptx drug coated balloon dilation catheter and minos™ ultra low-profile aaa stent-graft system. among them, castor® gained cfda approval in june, 2017.