Mozec™ NC PTCA Balloon Catheter

Key feature: controlled high-pressure dilatation

The Mozec™ NC balloon is made of a non-compliant nylon-based material. This design enables controlled high-pressure dilatation and is used for dilatation of stenotic coronary artery segments, including resistant lesions.

The low crossing profile and flexibility of the delivery system help advance the catheter to the target site through anatomically complex segments.

Design and crossability

The technical features of the catheter are intended to facilitate delivery to the target site and reduce the risk of vessel wall trauma.

• Low entry profile: the soft distal tip made of medical-grade PEBAX facilitates initial and repeat passage through stenotic segments.
• Smooth distal transition: hump-free fusion between the inner tube and the distal balloon tip helps support smooth system advancement.
• Optimized balloon shoulders: multilayer balloon folding reduces the deflated profile and facilitates passage through tortuous vascular segments.

Navigation and procedural control

The delivery system is designed to support visual and tactile control during positioning and dilatation.

• Hydrophilic coating: the coating from the distal balloon base to the Rapid Exchange / Rx port reduces friction and facilitates catheter advancement.
• Radiopaque markers: platinum-iridium alloy markers help visualize the working section of the balloon under fluoroscopy.
• Dual-lumen distal shaft: the outer lumen is used for balloon inflation and deflation, while the inner lumen is intended for the guidewire.
• Positioning indicators: visual markers on the proximal shaft help orient the catheter during radial and femoral access.

Indications and areas of use

• Balloon dilatation of stenotic coronary artery segments.
• Improvement of myocardial perfusion in cases of stenosis of bypass grafts, if specified in the manufacturer’s instructions.
• Post-dilatation of balloon-expandable stents after implantation.

Materials used

The system materials are selected with consideration for mechanical strength, hemocompatibility, and deliverability.

• Nylon: balloon material providing non-compliant properties during inflation.
• Medical-grade PEBAX: distal tip material intended to reduce trauma during passage.
• Platinum-iridium alloy: material of the radiopaque markers.
• Hydrophilic coating: coating that reduces friction during catheter advancement.

System components

The catheter is supplied as a kit, with the final configuration corresponding to the manufacturer’s documentation:

• Mozec™ NC balloon dilatation catheter;
• protective dispenser coil for catheter storage and removal;
• balloon refolding tool, if included in the supplied kit;
• needle for pre-flushing the system;
• clip for securing the catheter in the coiled position.

Certification and safety

• The device is supplied sterile and sterilized with ethylene oxide, if confirmed by the manufacturer’s documentation.
• The system is non-pyrogenic, if stated in the manufacturer’s instructions.
• The catheter is intended for single use.
• The size range allows balloon diameter and length to be selected according to vessel anatomy, lesion characteristics, and the clinical task.