Oceanus 14

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iVascular advises that product IFUs should be downloaded, issued and reviewed for operators reference before or during procedures with our devices.

Description

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:

  • The side port allows contrast medium passage to dilate the balloon
  • The straight port allows the guide wire insertion

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.

Indications

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.

Features

  • iVascular hydrophilic durable coating (HYDRAX) specifically designed for PTA balloon guarantees sustainable performance and control throughout the procedure.
  • Capable to reach the most challenging lesions due to the three-segment shaft design that increases flexibilities towards distal part.
  • Excellent pushability and trackability. Balanced transition of forces. Anti-kinking performance.
  • Extraordinary capacity to cross lesions. Streamlined tip and a low profile balloon designed to enter and cross difficult lesions.
  • Outstanding deflation time thanks to the exceptionally designed three-segment shaft.
  • Tungsten-based polymeric radiopaque markers for higher tip flexibility.
  • Wide balloon size range (200mm balloons).

Specifications

  • Catheter materials: Nylon/Pebax (the product does not contain latex components)
  • Balloon: Semi-compliant (10-15% from nominal pressure to RBP)
  • Nominal Pressure: 7 atm
  • Rated Burst Pressure (RBP): 16 atm
  • Average Burst Pressure (AVP): 22 atm
  • Radiopaque markers: flexible tungsten-based polymeric markers
  • Recommended guidewire: 0.014”
  • Crossing profile: 0.023” to 0.033”
  • Tip profile: 0.017”
  • Introducer compatibility: 4F for all diameters
  • Deflation time: 10s maximum for all diameter and lengths
  • Usable Catheter lengths: 100 cm or 150 cm
  • Available references

Package Contents

  • One OTW catheter covered by a protection sheath for the balloon and a stylet to protect the guidewire lumen. This is inserted into a dispenser in a sterile bag.
  • One card with the compliance curve showing the nominal inflation pressure and the recommended maximum pressure.
  • One leaflet with instructions for use.

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iVascular advises that product IFUs should be downloaded, issued and reviewed for operators reference before or during procedures with our devices.