南宫NG·28(中国)相信品牌力量

Shanghai, China - Recently, FONTUS™ Single-branched Stent Graft System in Surgical Operation (“FONTUS™”), which is independently developed by Shanghai MicroPort Endovascular MedTech Co., Ltd. (“MicroPort Endovascular”), has passed the review of China State Drug Administration (SDA) and entered the special review and approval procedure for innovative medical devices, which is also known as the Green Path.

The patients suffering from aortic diseases amount to 30 million in the world, with about 4 million in China and 40% of the Chinese patients developing diseases to ascending aorta. The aortic diseases pose serious threats to human lives and health, with aortic dissection and aortic aneurysm causing mortality of up to 90% in case of ruptures. The type A aortic dissection used to be regarded a curse for cardiovascular surgery, as it ranks among the most complex and dangerous cardiovascular diseases with 50% mortality within 48hours due to its rapid development and threat to life. The conventional procedures involve open chest surgeries for two times, where the patients had to sustain extremely big trauma with relatively high surgery mortality. About 15 years ago, CRONUS® Stent in Surgical Operation, which was the world’s first and jointly developed by Professor Lizhong Sun of Beijing Anzhen Hospital of Capital Medical University and MicroPort Endovascular, was launched with the establishment of the Sun’s Procedure, i.e. the aortic arch replacement combined with the elephant trunk procedure. The procedure can increase the rate of the sealing of the false lumen, significantly improving the long-term prognosis of the patients and reducing the second phase surgery rate. Should the patients need second phase surgery, it would be greatly simplified with fewer occurrences of complications and mortality due to the elephant trunk procedure. Since then on, the curse of acute aortic dissection has been defeated, with the mortality rate of A type dissection surgeries down to below 5% from 20%, the post-surgery false lumen sealing rate up to nearly 100% from 40%, and the second surgery rate down to 10% from 30%. The relatively standard procedure and significantly reduced mortality rate and complications help the Sun’s Procedure be widely accepted and save lots of lives. However, the room for further improvement has emerged during the promotion of the Sun’s Procedure, i.e. freeing and reconstruction of the left subclavian artery (LSA) are very likely to cause damages to vessels and nerves, and the deep incision on the aorta makes it difficult for anastomosis. The two aforementioned factors cause longer cardiopulmonary bypass, higher risks of hemorrhage and disturbances of the internal environment, as well as a series of post-surgery complications to the nervous system and other organs. Furthermore, the Sun’s Procedure demands delicate skills on the part of the surgeons, hampering its promotion at the hospitals outside of big Chines cities.

FONTUS™ is independently developed with innovation by MicroPort Endovascular as a next generation stent in surgical operation on the basis of CRONUS® Stent in Surgical Operation. Its single-branched stent structure avoids the deep freeing of the LSA, and leaves the anastomotic stoma of main body moved up, which lower the difficulty of the surgery and shorten the surgery time. The artificial vessels with collagen coating on the proximal part have been in use for years and can effectively prevent hemorrhage. The patent design of retrograde deployment, along with a prebent structure with adjustable branch, result in a more precise, smoother and safer release of the stent. The unique advantages will significantly boost the popularity of Sun’s procedure in the treatment of aortic dissection cases, so as to save more lives of the patients suffering the disease.

The Green Path is a major measure that China's drug regulator has introduced to promote the development of innovation in medical devices. It is hoped to play an active role to encourage the research and innovation in medical devices, promote the diffusion and application of new medical device techniques and drive the development of the medical device industry. With regard to the innovative medical devices with the green pass, the drug authorities and related technology institutions at various levels give priority to them in the review and approval procedure, with the other requirements unchanged. From 2015 to 2018, four products of MicroPort™ Endovascular, i.e. Castor® Branched Aortic Stent-Graft System (“Castor®”), Reewarm® PTX Drug Coated Balloon Dilation Catheter, Minos™ Ultra Low-Profile AAA Stent-Graft System and Talos™ Thoracic Stent Graft System, have been successively granted the Green Pass, as has Altura™ Endograft System, which is developed by MicroPort-invested Lombard Medical. Among those, Castor® was approved for marketing in June 2017. The entry of FONTUS™ into the Green Path not only marks an endorsement of its independent innovation, but will also expedite its marketing progress and benefit more patients suffering from the aortic diseases.