iVascular advises that product IFUs should be downloaded, issued and reviewed for operators reference before or during procedures with our devices.
The dilatation balloon catheter “Oceanus 14” is a coaxial catheter (OTW, over-the-wire), designed for percutaneous transluminal angioplasty of peripheral arteries.
The catheter has a coaxial double-lumen body from the proximal connector to the balloon. The guidewire runs into the inner lumen while the outer lumen allows contrast liquid passage to inflate the balloon. The maximum diameter of the guide wire must not exceed 0.36mm = 0.014”.
On the distal part of the catheter, just before the tip, there is the balloon (inflatable segment) that will dilate the artery upon inflating by means of infusion of contrast fluid inside it. The connector is Y-shaped and it has two entry ports:
To inflate the balloon, the connector inflation port must be connected to an inflation device. The balloon is inflated to predictable diameters with the pressure shown by the manometer.
Two flexible 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 inside the patient.
At the distal end is the tip, rounded for atraumatic behavior to avoid damaging the arteries while the catheter is being advanced.
The distal part, including the balloon, is coated with a durable and slippery hydrophilic coating (HYDRAX) that minimizes friction and improves catheter trackability.
See IFU for further information. Available to download.
Dilation of stenosis in femoral, popliteal, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, with a nominal diameter from 1.5 to 4.0 mm and lengths from 40 to 200 mm.