MicroPort® Endovascular Completed First Application of Reewarm™ PTX Drug Coated PTA Balloon Catheter
24 Mar 2015
Shanghai, China – 24 March, 2015 – MicroPort Endovascular (Shanghai) Co ("MicroPort Endovascular") recently successfully completed its first clinical application of Reewarm™ PTX Drug Coated PTA Balloon Catheter("Reewarm™ PTX") in the middle segment of superficial artery. The Reewarm™ PTX clinical trial is a prospective, multi-center, single blind, randomized, controlled study, comparing drug coated balloon ("DCB") versus standard balloon angioplasty for the treatment of femoropopliteal arteries, which is expected to enroll 200 patients (1:1) in 11 centers in China.
Reewarm™ PTX is an in-housed developed device of MicroPort Endovascular, designed for the treatment of peripheral arterial disease ("PAD") in the superficial femoral artery and popliteal artery. DCB technologies represent the latest development in the field of endovascular treatment of PAD, which combines balloon angioplasty and drug coating technology. Use of DCB and avoidance of stent implantation does not limit future treatment options, an important consideration given the chronic and progressive nature of PAD. Moreover, with no polymer carrier, DCB reduces the occurrence of chronic inflammation and late thrombosis.
MicroPort Endovascular's Reewarm™ PTX features unique coating formula and technology, which ensures that the drug is evenly coated on the balloon surface. The coating is composed of antiproliferative lipophilic paclitaxel with 3μg/mm2 in dose and hydrophilic carrier. Its special drug coating structure and hydrophilic nano-scale coating design provides precise drug release, which guarantees adequate drug supply in lesions and reduces drug residues in blood and other non-target lesions, so as to lower the incidence of side effect.
"Reewarm™ PTX provides patients with an additional option to treat PAD. It will also help enhance our competitiveness in the field of endovascular treatment," said Zhenghua Miao, President of MicroPort Endovascular.