Recently, the Falexpand® HP PTA Balloon Dilatation Catheter, independently developed by Kossel Medtech, after obtaining approval from the NMPA of China and the FDA of the United States, has now also obtained the Brazilian ANVISA certificate.
The Falexpand® HP PTA Balloon Dilatation Catheter is suitable for percutaneous transluminal angioplasty (PTA) of the peripheral vascular system (including the iliac artery, femoral artery, popliteal artery, tibial artery, fibular artery, and renal artery), and is suitable for the treatment of stenotic lesions in natural or artificial arteriovenous fistulas for dialysis.
Percutaneous transluminal angioplasty (PTA), as a routine solution for vascular access stenosis in clinical practice, is widely used both domestically and internationally, with high-pressure balloons being the core device for PTA treatment. Compared with conventional balloon catheters, peripheral high-pressure balloon catheters have higher inflation pressure, which can effectively dilate stubborn narrow lesions, while also having lower compliance, effectively reducing the incidence of vascular dissection.
The approval of the Falexpand® HP PTA Balloon Dilatation Catheter in Brazil enriches the product portfolio of Kossel Medtech in the overseas market, further enhancing the international influence of the company and its products. Kossel Medtech will continue to deepen its presence in the industry, focusing on research and innovation of products to create safer and more effective medical devices for the benefit of patients worldwide.
