Bogota, Colombia - MicroPort Endovascular (Shanghai) Co., Ltd. ("MicroPort® Endovascular") obtained the regulatory approval from Colombia's health authority INVIMA for its in-house developed Hercules™-T Low Profile Stent-Graft ("HT-LP"), Hercules™ Bifurcated Stent-Graft System and Delivery System, and Hercules™ Balloon Dilation Catheter. This is the first time for MicroPort® Endovascular's products to gain regulatory approval in Colombia. Previously, the three products have received approval in Brazil, Argentina, Peru, Thailand, Indonesia, and the Philippines.
HT-LP is built on the success of Hercules™ Thoracic Stent-Graft System. It is designed for the endovascular treatment of descending thoracic aortic disease. HT-LP has significant advantages in outer diameter and cross arch ability compared to similar products on the market. It is the first thoracic aortic aneurysm ("TAA") stent to have low profile delivery system with 18F outer diameter, the lowest among aortic stents in the world, which would benefit patients with narrow introducing femoral artery. Its soft inner sleeves are made of PET, which makes it easier for the stent to cross the aortic arch. The rear release mechanism of bare stent leads to more precise and stable positioning and deployment. The height-mutative main body stent improves the flexibility of the whole stent. It is expected that the launch of HT-LP will facilitate physicians to cope with the challenges in clinical treatment.
Hercules™ Bifurcated Stent Graft System is for the treatment of infra-renal abdominal aortic aneurysm ("AAA") with proximal aortic neck length longer than 15 mm. The main-body stent graft is composed of two mini-waves and one big wave, which ensure the stent match closely with the artery so as to reduce the type I endoleak risk and maintain appropriate radial strength as well. Limb stent graft with height mutative waves can conform to the tortuous iliac artery naturally. The overlapping length of the short leg and contralateral limb can be as long as 35mm, which make the size selection more convenient and reduce the type III endoleak risk.
Hercules™ Balloon Dilatation Catheter is mainly used for post-release stent expansion which allows the stent graft to fully fit the shape and contour of human blood vessels to prevent endoleak which is characterized by persistent blood flow within the aneurysm sac or false lumen following endovascular aneurysm repair ("EVAR"). This device used in combination with aortic stent graft offers a total solution for physicians and surgeons for treating aortic aneurysm or dissection.
As the third largest country in Latin America, Colombia has a population of 50 million with a huge, growing market for cardiovascular interventional and endovascular products. In 2017, Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") obtained the regulatory approval in Colombia. As HT-LP, Hercules™ Bifurcated Stent-Graft System and Delivery System, and Hercules™ Balloon Dilation Catheter gained the regulatory approval in Colombia, MicroPort® will further expand the Colombia market. With their outstanding performance, it is expected that they will provide better solutions for overseas patients and help MicroPort® Endovascular further enlarge its international market share, especially in Latin American countries.