Description

The Rapid Exchange balloon catheter (RX) “NC xperience” intended to dilate the stenotic portion of a coronary artery or the stenosis of bypass grafts, with the aim of improving myocardial perfusion and for the post-dilatation of the implantation of a stent in the area where it has been placed, in order to help positioning it against the arterial wall and to improve angiographic results.

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

• All types of dilatation even the most calcified lesions requiring high pressure inflation to improve myocardial perfusion
• Stent post-dilatation – to enhance stent artery wall apposition and wall and improve angiographic results

Features

• Ultra-los crossing profile.
• Non-compliant (7% highest compliance from nominal pressure to RBP)
• Nominal Presure: 12 atm
• Rated Burst Pressure (RBP): 20 atm Ø < 4.50 mm and 18 atm Ø ≥ 4.50 mm
• 2 metallic platinum iridium radiopaque markers.
• 6F kissing-balloon technique compatible.
• Hydrophilic durable coating (HYDRAX) specifically designed to guarantee sustainable performance and control throughout the procedure.

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.