shanghai, china - microport endovascular (shanghai) co., ltd. ("microport® endovascular") recently obtained the regulatory approval from china food and drug administration ("cfda") for its in-house developed reewarm™ pta balloon catheter ("reewarm™"). reewarm™ is designed to treat atherosclerosis-caused stenosis and occlusive disease in artery below groin, such as iliac artery, femoral artery, superficial femoral artery, popliteal artery, inferior genicular artery. it provides pre-expansion of the narrowed vascular lumen for future treatment.
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 lower limb necrosis and amputation, depending on the degree of narrowing at each vascular site. such disease has severely impacted the life quality of chinese senior citizens. according to statistics, the prevalence of peripheral arteria diseases is expected to be 20 to 30 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 with an ever increasing incidence rate. however, medical devices to treat peripheral arteria diseases are currently dominated by foreign companies. zhenghua miao, president of microport® endovascular, said: "as a domestically developed product, the market launch of reewarm™ in china is expected to benefit chinese patients with its high-quality and affordable price."