Brasilia, Brazil, 4 July 2022 — Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (“Endovastec™”) today announced that it has received registration approval from the Brazilian Health Regulatory Agency (ANVISA) for its independently developed Reewarm™ paclitaxel (PTX) drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) Catheter (“Reewarm™ PTX”).
The Reewarm™ PTX DCB PTA Catheter is indicated for the treatment of atherosclerotic stenosis or occlusive lesions in the lower extremities and is used for balloon dilatation of the popliteal artery during PTA. Atherosclerotic stenosis or occlusive lesions can be treated by inhibiting the proliferation of smooth muscle cells through the action of paclitaxel on the diseased vessel wall. Using Reewarm™ PTX, the long-term inhibition of smooth muscle proliferation is achieved by a one-off drug delivery without any foreign body implantation. The unique coating formulation and spraying process of the Reewarm™ PTX DCB PTA Catheter enables precise drug release. Moreover, it ensures a steady and reliable drug supply at the lesion site, whilst reducing residual drug content in the blood and other non-target lesion sites, hence lowering the incidence of adverse reactions. It features small drug particles and a high vessel wall absorption rate, reducing the risk of distal embolism that could be caused by larger particles.
As one of Endovastec™’s core products in the field of peripheral artery disease treatment, the Reewarm™ PTX was granted marketing approval by the National Medical Products Administration (NMPA) in May 2015 and obtained the CE marking in December 2015.
Mr Qing Zhu, President of Endovastec™, stated: “The Reewarm™ PTX has shown excellent clinical performance since its launch. It has provided a better surgical solution for the treatment of peripheral artery diseases, and elevated our market competitiveness in the field of peripheral vascular intervention. In the future, Endovastec™ will continue to develop and produce more high-quality, high-end medical devices to benefit more patients worldwide.”