The EluNIR™ Ridaforolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions ≤30mm in length in native coronary arteries with reference diameters of 2.50mm to 4.25mm.
Coronary artery stenting is generally contraindicated in the following patient types:
- Patients who cannot receive recommended antiplatelet and/or anticoagulation therapy.
- Patients judged to have a lesion which prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery system.
- Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ridaforolimus or similar drugs, the polymer or its individual components CarboSil® 20 55D (Thermoplastic Silicone-Polycarbonate-urethane) and Poly n-Butyl Methacrylate (PBMA), cobalt, chromium, nickel, molybdenum, or contrast media.
- Please ensure that the inner package has not been opened or damaged as this would indicate that the sterile barrier has been breached.
- The use of this device carries the associated risks of thrombosis, vascular complications and/or bleeding events.
- This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.
- Stent implantation should only be performed by physicians who have received appropriate training.
- Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcomes following repeat dilatation of the stent is presently not well characterized.
- Risks and benefits should be considered in patients with severe reaction to contrast agent.
- Patients with known hypersensitivity to the product components (stent substrate, polymer(s), drug substance) may suffer an allergic reaction to this implant.
- Do not expose or wipe the product with organic solvents such as alcohol.
- Care should be taken to control the guiding catheter tip during stent delivery, deployment, and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.
- Stent thrombosis is a low-frequency event that is frequently associated with myocardial infarction (MI) or death.
- When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the EluNIR™ clinical trials.
- Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications, including more tortuous anatomy, may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.