Indications
The device is indicated for dilation of stenosis located in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial, with a reference diameter balloon from 5 to 7 mm and lengths from 20 to 150 mm. It is also indicated for stent post-dilation in the peripheral vascular system.
Features
– iVascular’s proprietary coating technology “Transfertech”. Nanotechnology drop dosage system that yields a multilayer thin coating.
– Improved coating mechanical resistance. Better adhesion to the balloon
– Homogeneous and precise Paclitaxel concentration of 3 µg/mm2 on the balloon for an effective treatment of the whole injury
– Microcrystalline coating for faster drug absorption rate. Rapid release of Paclitaxel with long-term efficacy.
– Segmented catheter design for excellent pushability and trackability. Balanced transition of forces. Enhanced dual lumen shaft design. Anti-kinking performance.
– Outstanding crossing profile thanks to the 6 wings folding and 3 wings re-folding for easy extraction through the sheath.
– Very short balloon deflation rates.
– Wide balloon size range (150mm balloons)
– Proprietary hydrophilic coating “Hydrax” on the shaft of the catheter to improve trackability
Specifications
– Catheter materials: Nylon/Pebax (the product does not contain latex components)
– Drug: 3 µg/mm2 Paclitaxel
– Excipient: Organic ester. Lipophilic, biocompatible and biodegradable.
– Balloon: Semi-compliant (10 from nominal pressure to RBP)
– Nominal Presure: 6/7 atm
– Rated Burst Pressure (RBP): 16 atm
– Average Burst Pressure (AVP): 23 atm
– Recommended guidewire: 0.035”
– Crossing profile: 0.037”
– Introducer compatibility: 5F (d=5mm), 6F (d=6mm, d=7mm)
– Deflation time: < 5s
– 2 Platinum / Iridium radiopaque markers embedded at the guidewire lumen
– Working catheter lengths: 80 cm and 140 cm
