Description

Paclitaxel-eluting balloon is a coaxial catheter OTW, designed for percutaneous transluminal angioplasties of small peripheral arteries. The balloon is coated with a homogeneous mixture of Paclitaxel, a derivative of Taxol, and a physiologically innocuous matrix, the excipient. The balloon coating technology is called “Transfertech”, based on multilayered nanodrops.The drug’s dose is 3 µg/mm2 of balloon surface and it is intended to avoid cellular proliferation, consequently decreasing re-intervention rate. The drug is released from the balloon by means of a rapid inflation so that a high dose is released in a very short period of time. In order to assure a sufficient dosage of Paclitaxel onto the arterial wall, inflation process must last from 30 seconds to 1 minute. Two radiopaque markers are located at each end of the balloon in order to mark its length and help the user to see the catheter while navigating inside the patient. Nanotechnology drop dosage system that yields a multilayer thin coating. The balloon is indicated for stenosis in iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial. It is also indicated for stent post-dilation in the peripheral vascular system. Balloon diameter from 2 to 8 mm and lengths from 20 to 200 mm.