MicroPort® Endovascular Completed Enrollment of Pre-market Clinical Trial for Reewarm18
20 Dec 2014
MicroPort Endovascular (Shanghai) Co ("MicroPort® Endovascular") recently completed the enrollment of pre-market clinical trial for its first-generation Reewarm18 Peripheral Balloon Dilation Catheter ("Reewarm18") to prove its safety and efficacy.
Reewarm18 is designed to treat peripheral vascular stenoses and occlusions (femoral artery, superficial femoral artery, popliteal artery, infrapopliteal arterial). As MicroPort® Endovascular's first-generation of peripheral balloon dilation catheter system, Reewarm18 features excellent pushability, higher flexibility, outstanding crossing-ability, lower compliance, shorter inflation/deflation time, as well as the widest codes with balloon diameter compared to other competitors' peripheral balloon dilation catheters.
The market launch of Reewarm18 is expected to break the domination by foreign companies to treat peripheral arteria diseases which have severely impacted the life quality of Chinese senior citizens. It is known that the prevalence of the disease is expected to be around 20 percent in a population aged over 65 and it is estimated that there are around 60 million people suffering from peripheral arteria diseases in the world. As one of the most common peripheral arteria diseases, lower extremity arterial disease ("LEAD") is mainly caused by arterial atherosclerosis with narrowing or blocking of the arteries in the legs and feet, and would cause a range of severity of symptoms such as claudication, rest pain and even limb necrosis which may lead to amputation, depending on the degree of narrowing at each vascular site.
"Endovascular therapy, such as balloon dilatation and stent implantation, is currently the most effective way to treat LEAD. It improves the blood supply to the extremities with the advantages of minimal invasion and short recovery time," said Zhenghua Miao, President of MicroPort® Endovascular. "We are looking forward to seeing Reewarm18 launched in the China market, so as to benefit Chinese patients with its high-quality and affordable price."