Oceanus 14 Pro

balloon dilatation catheter

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Description

The  balloon dilatation catheter “Oceanus 14 Pro” 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.

In Oceanus 14 Pro, there are different type of radiopaque markers to have greater visibility and flexibility in each size:

– Balloon with diameter ≤ 2.0mm and length ≤ 20mmà 1 tungsten marker in the middle of the balloon.

– Balloon with diameter ≤ 2.0mm and length > 20mm à 2 tungsten markers. Located at each end of the ballon.

– Balloon with diameter ≥ 2.5mm à 2 Pt/Ir markers. Located at each end of the ballon

 

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.

The distal part, including the balloon, is coated with a durable and slippery  hydrophilic coating that minimizes friction and helps the catheter go through tortuous arteries smoothly.

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 1.25 to 4.0 mm and lengths from 10 to 200 mm.

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 and metal (Pt/Ir) markers
  • Recommended guidewire: 0.014”
  • Crossing profile: 0.021” 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.

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 flexibility in small balloons (diameter ≤ 2.0mm)
  • Metal radiopaque markers for better visibility in bigger balloons (diameter > 2.0mm)

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