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 35” is a coaxial catheter (OTW, over-the-wire), designed for percutaneous transluminal angioplasty of large 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 0.89mm = 0.035”.
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 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, which is rounded and atraumatic in shape in order to avoid damaging the arteries while it is being advanced.
Its entire surface, from tip to hub, is homogeneously coated with a lubricious silicone based coating to minimize friction and facilitate navigation through vessels.
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 5 to 12 mm and lengths from 20 to 200 mm.