MOZEC™ SEB sirolimus drug-coated PTCA balloon catheter

Key feature: sirolimus delivery system based on solid lipid nanoparticles

MOZEC™ SEB uses a drug coating containing sirolimus and solid lipid nanoparticles (SLN). This system is designed to transfer the drug substance to the vessel wall during balloon dilatation.

The lipid matrix helps retain the drug on the balloon surface during delivery to the target site and supports its transfer into the vessel wall tissue during balloon inflation.

Catheter crossability and design

The catheter design is intended to deliver the device to the stenotic coronary artery segment and reduce the risk of vessel wall trauma.

• Proximal shaft with PTFE coating: the coating reduces friction and supports catheter advancement through anatomically complex segments.
• Low-profile distal tip: facilitates entry into the stenotic area and passage through the lesion segment.
• Semi-compliant balloon: the balloon material provides controlled expansion and contact with the vessel wall during inflation.
• Transparent ergonomic hub: allows visual control of device parameters and simplifies catheter preparation.
• Combination of flexible distal and more rigid proximal segments: supports push force transmission and controlled system advancement.

Visualization and positioning

The catheter is equipped with radiopaque markers for balloon position control during the intervention.

• Platinum-iridium radiopaque markers: help visualize the working section of the balloon under fluoroscopy.
• Balloon border control: visualization of the distal and proximal balloon borders helps position the device within the lesion area.

Drug action and coating

The MOZEC™ SEB therapeutic coating is designed for local delivery of an antiproliferative drug to the vessel wall.

• Antiproliferative action of sirolimus: sirolimus is intended to reduce smooth muscle cell proliferation and the risk of neointimal hyperplasia.
• Lipid matrix: solid lipid nanoparticles are used as a drug carrier and help reduce drug loss during catheter advancement.
• Local drug delivery: the coating enables sirolimus transfer into the vessel wall during balloon contact with the lesion segment.

Indications and areas of use

• Dilatation of stenotic coronary artery segments.
• Treatment of patients with coronary artery disease.
• Treatment of in-stent restenosis, including bare-metal stents and drug-eluting stents, if specified in the manufacturer’s instructions.
• Post-dilatation of balloon-expandable stents, if stated in the manufacturer’s documentation.

Benefits for the clinic and physician

• Size range: balloon diameter and length options allow catheter selection according to vessel diameter, lesion length, and the clinical task.
• Compatibility with PCI instrumentation: the catheter is intended for use with compatible guide catheters and standard coronary guidewires, if confirmed by the manufacturer’s instructions.
• Integration into a standard PCI protocol: the catheter design allows it to be used within percutaneous coronary intervention procedures.

Certification and safety

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