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Shanghai, China—Reewarm™ PTX Drug Coated PTA Balloon Catheter (“Reewarm™ PTX DCB Catheter”) developed by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (“Endovastec™”) has recently obtained the CE Marking certification issued by the European Union. Previously, the product has received the registration certificate issued by China’s National Medical Products Administration (NMPA) in April 2020.

The Reewarm™ PTX DCB Catheter is designed for balloon dilation in the femoral popliteal artery during percutaneous transluminal angioplasty. Relying on the inhibiting effect of paclitaxel on the lesioned vessel wall, it is used to treat atherosclerotic stenosis or occlusive lesions by inhibiting the proliferation of smooth muscle cells. The unique coating formulation and spraying process of the Reewarm™ PTX DCB Catheter enable precise drug release and ensure a steady and sufficient drug supply at the lesion site while reducing residual drug in the blood and other non-target lesion sites, hence lowering the incidence of adverse reactions. The DCB catheter features small drug particles and a high absorption rate into the vessel wall, also reducing the risk of distal embolism that could be caused by larger particles.

Lower extremity arterial disease has become a global threat to human health, and it’s increasingly prevalent with as the population ages and their diet changes. According to statistics, there are over 200 million people globally who are suffering from lower extremity arterial disease, which can cause claudication, resting pain, in some cases leading to amputation, seriously affecting patients’ quality of life. With the treatment concept of “single drug administration for long-term inhibition of smooth muscle cell proliferation without foreign body implants”, drug coated balloons can significantly reduce the incidence of clinical complications and the frequency of re-intervention while relieving patients’ pain and saving medical resources.

“Previously, we have received the CE Marking for the Minos® Abdominal Aortic Stent-Graft, the Hercules™ Low-Profile Thoracic Stent-Graft, and many other products by Endovastec™,” said Zhenghua Miao, President of Endovastec™. “The certification of the Reewarm™ PTX DCB Catheter further strengthens the product portfolio of Endovastec™ in the EU and related overseas markets.”