altura™ endograft system granted cfda green-云顶国际

shanghai, china – on december 6, altura™ endograft system ("altura™"), distributed by microport endovascular (shanghai) co., ltd. ("microport®endovascular") and developed by uk-based lombard medical, inc. ("lombard medical"), was granted 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.

in recent years, with the aging global population and improvement of diagnosis technology, the morbidity and definitive diagnosis rate of abdominal aortic aneurysm ("aaa") is increasing year by year. aaa is not self-healing. if the aaa patients can't be treated in time, they may die from aneurysm rupture. endovascular aortic repair ("evar") has been the primary solution of high-risk aaa. currently, branched stent-graft is the most commonly used device in evar treatment. altura™ is the world's first and only device boldly and effectively evolving the conventional bifurcated main body into unique bilateral d-stent design, with ultra-low profile of 14f. the unique bilateral d-stent design of altura™ enables the offset aortic endografts to be independently positioned, maximizing seal in infrarenal neck. besides, the proximal portion of the aortic endografts with the design of uncovered suprarenal bare stent and active anchor fixation minimizes the occurrence rate of complications of endoleak and stent migration, to provide a simple, reliable solution for physicians in the treatment of aaa.

previously, the altura™ system received ce mark in 2015. in april 2017, microport scientific corporation ("mpsc") signed an agreement with lombard medical which provides mpsc with the exclusive marketing rights for lombard medical's products aorfix™ and altura™ aaa stent graft product lines in china and brazil, as well as the right to a technology license to manufacture the products for the china market.

from 2015 to 2017, four products in-house developed by microport®endovascular, including castor™ branched aortic stent graft system, reewarm™ ptx drug coated balloon dilation catheter, minos™ ultra low-profile aaa stent-graft system, and talos™ thoracic stent graft system, had entered into the cfda green-path. altura™ is first imported product of microport®endovascular that gained the cfda green-path, which shows government authority's recognition in its innovation and will accelerate its approval procedure. it is expected that the launch of altura™ will help promote the application of the new product and technology in china's endovascular repair industry, and thereby benefit more local patients.