Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System Promus Elite Everolimus-Eluting Platinum Coro

FDA-Cleared Indications

• Modification to the midshaft adhesive bond length.

Clinical Applications

• Use within the coronary arteries as part of a coronary stent system.
• Placement after percutaneous coronary intervention to support the treated coronary segment.
• Delivery of everolimus from a drug-eluting coronary stent system.

Reported off-label uses

• Use in selected coronary anatomy or clinical situations outside the specific approved labeling may occur in practice, but such use should be determined by the treating interventional cardiologist.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The system is a balloon-expandable, everolimus-eluting stent made with a platinum chromium platform; available diameters and lengths depend on the specific product configuration.
• It is delivered through a compatible coronary guide catheter and guidewire during fluoroscopic angiography; vessel preparation and accurate sizing are important.
• Patients generally require antiplatelet medication after placement. The treating cardiologist determines the drug regimen and duration.
• MRI conditions should be confirmed in the current device labeling before scanning; the stent is not automatically safe for every MRI setting or protocol.
• Contraindications and precautions include unsuitable vessel anatomy, inability to receive required antiplatelet therapy, significant bleeding risk, and known sensitivity to device or drug components.