Mozec™ PTA Balloon Dilatation Catheter

Key feature: hydrophilic coating and low shaft profile

The distal section of the Mozec™ PTA catheter has a hydrophilic coating that reduces friction during advancement through the vasculature. Combined with a low entry profile, this supports crossability, steerability, and delivery of the catheter to the target site.

The catheter design is intended to pass through tortuous vascular segments and stenotic areas with controlled resistance during advancement.

Design and biomechanics

The Mozec™ PTA catheter architecture is designed for controlled balloon dilatation of peripheral vessels and to reduce the risk of tissue trauma outside the treatment zone.

• Short balloon shoulders: the balloon shoulder design is intended to reduce impact beyond the stenotic segment.
• Radiopaque markers: two platinum-iridium markers help visualize the working section of the balloon and position it relative to the lesion under fluoroscopic guidance.
• Soft distal tip: the atraumatic tip facilitates system advancement over the guidewire and is intended to reduce the risk of vessel wall injury.
• PEBA balloon material: the balloon made of PEBA polymer provides controlled expansion in response to pressure changes in the inflation device.

Ergonomics and workflow adaptability

The system is available in configurations that allow catheter selection according to anatomy, access route, and the preferred intervention technique.

• OTW and Rx configurations: the catheter is available in Over-The-Wire (OTW) and Rapid Exchange (Rx) versions, if provided in the manufacturer’s product range.
• Transparent Y-connector: the ergonomic hub provides a secure grip and allows visual control during device preparation and flushing.
• Size range: balloon diameter and length options allow catheter selection according to vessel caliber, lesion length, and the clinical task.
• High-pressure use: the high rated burst pressure (RBP) of the balloon may be useful for dilatation of calcified or resistant lesions. Specific pressure values should be stated according to the manufacturer’s documentation.

Indications and areas of use

• Dilatation of stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries.
• Treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulas.
• Post-dilatation of stents in the peripheral vasculature, if specified in the manufacturer’s instructions.

Materials and components

• Balloon material: biocompatible PEBA polymer.
• Radiopaque markers: platinum-iridium alloy.
• Shaft: dual-lumen system in the OTW configuration, providing separate channels for the guidewire and balloon inflation.
• Hydrophilic coating: coating on the distal section of the catheter that reduces friction during system advancement.

Certification and safety

• The device is intended for single use.
• The catheter is supplied sterile and sterilized with ethylene oxide (EO), if confirmed by the manufacturer’s documentation.
• Non-pyrogenic status and biocompatibility should be stated in accordance with the manufacturer’s instructions.
• CE marking and compliance with applicable medical device safety requirements should be confirmed by current manufacturer documentation.