Shanghai, China – The Reewarm® PTX Drug Coated Balloon PTA Catheter (“Reewarm® PTX DCB Catheter”), developed by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (“Endovastec™”), has received CE marking certification in the European Union.
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.
“We previously received CE marking certification for the Minos® Abdominal Aortic Stent-Graft, the Hercules™ Low-Profile Thoracic Stent-Graft, and many other products,” said Zhenghua Miao, President of Endovastec™. “The certification of the Reewarm® PTX DCB Catheter further strengthens our product portfolio in the EU and international markets.”
Lower extremity arterial disease has become a global threat to human health, and it is increasingly prevalent due to the ageing population and dietary changes. According to statistics, over 200 million people globally suffer from lower extremity arterial disease, which can cause claudication, resting pain and in some cases can lead to amputation, seriously affecting patients’ quality of life.
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, thereby 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.
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.