PROMESA™ BMS Peripheral Stent System

Key feature: hybrid architecture and controlled delivery

The Promesa™ BMS stent combines a hybrid cell design: closed cells at the proximal and distal ends and open cells in the middle section. This architecture is intended to balance longitudinal flexibility, conformability, and radial support in the peripheral vasculature.

The Tactile Handle System delivery system with a rotating wheel allows stepwise stent deployment and controlled positioning in the target zone.

Design and crossability

The system’s technical features are intended to support navigation through anatomically complex segments and maintain the mechanical stability of the implant.

• Optimized delivery profile: the 6F Braided Sheath supports a balance between pushability and trackability and may allow contrast media injection during the procedure, if specified in the manufacturer’s instructions.
• Longitudinal flexibility: the flexibility of the delivery system facilitates navigation through tortuous vascular segments and access through the aortic bifurcation using a contralateral approach.
• Mechanical stability of the stent: the 170 μm strut thickness, combined with an electropolished surface, is intended to support structural integrity and resistance to mechanical loads during implantation and use.

Ergonomics and navigation

The system is designed to support visual and tactile control during implantation.

• Controlled deployment mechanism: the ergonomic handle with a rotating wheel allows gradual one-handed stent deployment. An audible click at full stent release serves as an additional tactile and acoustic indicator. For stents longer than 120 mm, an additional puller shaft is provided.
• Radiopaque markers: tantalum markers on the stent — 3–4 markers at each end — and platinum-iridium marker bands on the inner catheter shaft help control stent position under fluoroscopy.
• OTW design: the Over-The-Wire catheter is compatible with a 0.035“ / 0.89 mm guidewire along the full length of the system, from the hub to the soft tip, if confirmed by the manufacturer’s documentation.

Indications and areas of use

• Treatment of atherosclerotic lesions in peripheral arteries in patients indicated for percutaneous transluminal angioplasty (PTA).
• Restoration of the lumen of the superficial femoral artery / SFA with a reference vessel diameter of 5.00 to 7.00 mm.
• Restoration of the lumen of the iliac artery with a reference vessel diameter of 7.00 to 10.00 mm.

Materials used

The system materials are selected with consideration for biocompatibility, visualization, and mechanical strength.

• Nitinol alloy: material of the self-expanding stent with shape-memory properties.
• Tantalum: used for radiopaque markers at the stent ends.
• Platinum-iridium alloy: used for marker bands on the delivery catheter.
• Medical-grade polymers: used in the triaxial construction of the delivery system.

System components

The stent system is supplied preloaded on the delivery catheter. The final configuration should correspond to the manufacturer’s documentation.

• Promesa™ BMS self-expanding stent, preloaded on the delivery catheter.
• Protective circular tray with securing element.
• Instructions for use.
• Patient stent implant cards.

Certification and safety

• The device is supplied sterile and sterilized with ethylene oxide (ETO), if confirmed by the manufacturer’s documentation.
• Non-pyrogenic status should be stated in accordance with the manufacturer’s instructions.
• The system is intended for single use.
• The size matrix includes configurations with stent diameters from 5.0 to 10.0 mm, lengths from 30 to 180 mm, and delivery catheter working lengths of 80 cm or 120 cm, if these parameters are confirmed by the manufacturer.
• A 3-year shelf life should be stated only if confirmed in the IFU, package labeling, or technical datasheet.