Paclitaxel eluting balloon with coaxial design (OTW), intended for dilatation or opening of stenosis located at the femoral, popliteal and infrapopliteal arteries that appear with diameters between 1.5 and 4mm and longitudes between 40 and 200mm, through percutaneous transluminal angioplasty (PTA). The catheter features two coaxial tubes throughout its length; it has a dual lumen from the proximal connection to the balloon. The inner lumen is for guide wire insertion (max. diameter 0.014) and leading to the lesion; while the outer lumen allows contrast liquid passage for balloon in-deflation and this it comprises the in-deflation channel. The balloon is coated with the drug Paclitaxel; which is included in a physiologically innocuous matrix. Drug dose is 3 micrograms / mm2 of balloon surface and its purpose is to avoid cellular proliferation in order to lower re-intervention rate. Drug release takes place by a fast inflation of the balloon so that a high dose of drug is eluted in a very short period of time. In order to assure drug release to the vessel wall, inflation duration must stay between 30 seconds and 1 minute, although dilatation of the injury can be optimized by longer inflation times at operators will.
- Area of the body: : peripheral
- Application: : percutaneous transluminal angioplasty, dilatation
- Characteristics: : drug eluting, balloon