Xperience

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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 Rapid Exchange ballon catheter (RX) “xperience” is designed for percutaneous transluminal angioplasty of coronary arteries.

The shaft of the catheter features a combination of a single lumen at the proximal end and double lumen at the distal end:

  • Proximal part: single lumen that comprises a hypotube which provides the catheter with high pushability and allows in/deflation liquid passage to the balloon.
  • Distal shaft: configuration of double coaxial lumen with two functions:
    • Inner lumen for guide wire passage
    • Outer lumen for in/deflation

At the distal end of the Xperience Catheter, before the tip, there is the balloon (segment inflatable) which dilates the artery when inflated by means of an infusion of contrast liquid inside it. The balloon is preset to reach different diameters at different pressures (according to the compliance curve shown on the primary packaging).

Two radiopaque markers are fitted at each end of the balloon in order to mark its length and help the user track the device while inside the patient.

The distal part of the catheter is coated with a durable hydrophilic coating (HYDRAX) that minimizes friction and improves catheter trackability. The catheter ends in a cone-shaped tip which is rounded and atraumatic in shape in order to avoid damaging the arteries while it is being advanced.

At the proximal part there is the luer hub in order to attach different accessories.

The maximum diameter of the guide wire must not exceed 0.36 mm = 0.014”.

See IFU for further information. Available to download.

Indications

Dilatation of the stenotic portion of a coronary artery or stenosis of bypass grafts replacing coronary arteries, in order to improve myocardial perfusion.

Features

  • Outstanding deliverability. Able to open the most challenging lesions.
  • Perfect balance between strength and flexibility to cross the most challenging lesions in tortuous anatomies.
  • Accurate distal control thanks to its smooth force transition: optimized pushability with outstanding distal flexibility.
  • Hydrophilic durable coating (HYDRAX) specifically designed for PTCA balloon guarantees sustainable performance and control throughout the procedure.
  • Exceptional lesion crossing capability due to its low tip profile.
  • 6F kissing-balloon technique compatible.
  • Tungsten-based polymeric radiopaque markers for higher tip flexibility.

Specifications

  • Catheter materials: Nylon/Pebax (the product does not contain latex components)
  • Balloon: Semi-compliant (10-15% from nominal pressure to RBP)
  • Nominal Presure: 6 atm
  • Rated Burst Pressure (RBP): 16 atm
  • Average Burst Pressure (AVP): 20 atm
  • Radiopaque markers: tungsten-based flexible polymeric radiopaque markers.
  • Recommended guidewire: 0.014”
  • Introducer compatibility: 5F for all diameters and 6F for kissing-balloon technique
  • Deflation time: 3s average
  • Catheter working length: 142 cm
  • Available references
xperience

Click to enlarge

Package Contents

  • One rapid-exchange balloon catheter covered by a protective sheath for the balloon and a stylet in the guidewire lumen, inserted into a dispenser and packed in a sterile bag.
  • One card with the compliance curve showing the working range of pressures.
  • One leaflet with instructions for use.

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