


Implantation of the stent should be performed only by the physicians who have received appropriate training.The distal and intermediate portions of the device, the tip, and tapers of the balloon are coated with HYDROCOAT™ Hydrophilic Coating.įailure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
#Premier labs heart pro full
The XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are coated with an everolimus and polymer coating at the full implant stent length.Judicious selection of patients is necessary, since the use of this device carries the associated risk of stent 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.Antiplatelet therapy should be administered post-procedure.It is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon.Contamination of the device and / or delivery system may lead to injury, illness, or death of the patient. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and / or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and / or delivery system and / or lead to device failure, which may result in patient injury, illness, or death. Note the product “Use by” date on the package. Each stent and the delivery system are for single use only.Patients with hypersensitivity or contraindication to everolimus or structurally-related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, methacrylic polymer, fluoropolymer), or with contrast hypersensitivity.Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.The XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are contraindicated for use in:

In addition, XIENCE Skypoint™ Stent System is indicated with reference vessel diameters of ≥ 2.25 mm to ≤ 5.25 mm.
