Oceanus 35

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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 catheterOceanus 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:

  • 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 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.

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 5 to 12 mm and lengths from 20 to 200 mm.

Features

  • Excellent pushability and trackability due to the enhanced dual lumen shaft design.
  • Outstanding crossing profile thanks to the 6 wings folding and 3 wings re-folding for easy extraction through the sheath.
  • Up to 76% faster deflating balloon than the competitors.
  • Balanced transition of forces. Anti-kinking performance.
  • Conic atraumatic tip design for optimal crossing of severe lesions.
  • Advanced Y hub with an ergonomic design to facilitate one-hand removal.
  • Wide balloon size range (200mm balloons).

Specifications

  • Catheter materials: Nylon/Pebax (the product does not contain latex components)
  • Balloon: Semi-compliant (10% from nominal pressure to RBP)
  • Nominal pressure: 6/7 atm
  • Rated Burst Pressure (RBP): 13 – 16 atm
  • Avarage Burst Pressure (ABP): 19 – 24 atm
  • Radiopaque markers: platinium/iridium markers embedded at the guidewire lumen
  • Recommended guidewire: 0.035”
  • Crossing profile: from 0.057’’ up to 0.083’’
  • Tip Profile: 0.036”
  • Introducer compatibility: 5F (d=5mm, d=6mm), 6F (d 7 – 12 mm)
  • Deflation time: 10s maximum for all diameter and lengths
  • Usable Catheter length: 80 cm and 140 cm
  • Available references
oceanus 35

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Package Contents

  • One OTW catheter covered by a protection sheath for the balloon, 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.