Branched Aortic Stent-Graft System

Reshaping Health Professional Training Branched Aortic Stent-Graft System

Purpose

Cooperation on scientific researches to conclude the 863 Project, and finally achieve commercialization.

Background

With the increasing incidence of atherosclerosis, the arteriectasia represented by aortic aneurysm and aortic dissection has become a common disease in China. These diseases have serious complications such as rupture, limb and visceral ischemia and paraplegia, with a high rate of disability and fatality.

The traditional treatment for arteriectasia is lesion aorta replacement, which leads to great trauma and high complication and mortality rates. The presence of stent graft EVAR (endovascular aneurysm repair) has greatly reduced surgical trauma and has gradually become the main treatment for aortic dilatation. Previously, the products in the market are only applicable to the lesions that don’t involve branch artery, with the treatment limited for the descending aortic aneurysm and descending aorta dissection (Standford - B type or Debakey - Ⅲ type).

However, a major part of thoracic aortic aneurysm and thoracic aortic dissection involve the ascending aorta and aortic arch with the important branch artery. The treatments of such lesions with conventional artificial vascular replacement are extremely complicated with big trauma and high fatality rate, which makes interventional treatment all the more necessary. Due to the lack of suitable graft system, this type of lesion still remains a relative contraindication to stent graft EVAR (Standford-A type, Debakey-Ⅰ type, Debakey-Ⅱ type)

The Branched Aortic Stent-Graft System is developed to treat lesions involving the aortic arch. It can be used in the EVAR of thoracic aortic aneurysm and aortic dissection, and expands the use of EVAR of thoracic aortic aneurysm and aortic dissection from in descending aorta to in both ascending aorta and aortic arch. This product can not only treat the lesions of ascending aorta and aortic arch, but also replace the existing stent graft for the treatment of descending aorta. The Stent-Graft system overcomes part of the weakness of existing products, reduces surgical complications, and makes the treatment safer and reliable.

The Stent-Graft System is the first single branch aortic stent system in the world, and it is the first choice to treat left subclavian artery dissection. As of the end of 2018, its sales exceeded 30 million yuan. The system has been recognized and praised by clinicians.

History

  • The Branched Aortic Stent-Graft System is a successor to the national 863 Program and was developed as a new generation of products on the basis of the achievements obtained in the national 863 Project. During the national 863 Project, MicroPort® cooperated with a top-tier hospital in Shanghai to complete the prototype of the branched stent-graft and animal trials.
  • In 2008, MicroPort® officially launched the project.
  • In April 2013, the project completed the first clinical implant.
  • In May 2015, the project completed clinical trials successfully.
  • In June 2017, the Branched Aortic Stent-Graft System received the registration certificate for medical devices. It is the first approved branched aortic stent graft in the world.

Achievements

Successfully concluded 863 projects and achieved the commercialization and product launch.