1125350-28  Xience Alpine RX Stent  3.5x28 DES

XIENCE ALPINE OFFERS SOLUTIONS FOR TODAY'S COMPLEX CHALLENGES

• PROVIDES PEAK PERFORMANCE IN INCREASINGLY COMPLEX LESIONS
  • Catheter specifically designed for high performance in complex anatomy
  • The only CTO indicated stent

• IMPROVES QUALITY OUTCOMES123
• The Safety of XIENCE for complex patients
• XIENCE Safety offers outcomes that may reduce readmissions

INDICATIONS

The XIENCE Family of Everolimus Eluting Coronary Stent Systems are indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions for XIENCE V (length ≤ 28 mm), XIENCE PRIME, XIENCE Xpedition and XIENCE Alpine (lengths ≤ 32 mm) with reference vessel diameters of ≥2.25 mm to ≤ 4.25 mm. Additionally, the entire XIENCE Family is indicated for treating de novo chronic total coronary occlusions.

CONTRAINDICATIONS

The XIENCE Family of stents is contraindicated for use in patients:

• Who cannot receive antiplatelet and/or anti-coagulant therapy
• With lesions that prevent complete angioplasty balloon inflation or proper placement of the stent or stent delivery system
• With hypersensitivity or contraindication to everolimus or structurally-related compounds, cobalt, chromium, nickel, tungsten, acrylic, and/or fluoropolymers.

WARNINGS
 

• Ensure that the inner package sterile barrier has not been opened or damaged prior to use.
• Judicious patient selection is necessary because 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.

PRECAUTIONS
 

• Stent implantation should only be performed by physicians who have received appropriate training.
• Stent placement should be performed at hospitals where emergency coronary artery bypass graft surgery is accessible.
• Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcomes following repeat dilatation of the stent are presently unknown.
• Risks and benefits should be considered in patients with severe contrast agent allergies.
• 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 SPIRIT family of trials.
• Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.
• Orally administered everolimus combined with cyclosporine is associated with increased serum cholesterol and triglycerides levels.
• A patient’s exposure to drug and polymer is proportional to the number and total length of implanted stents. See Instructions for Usefor current data on multiple stent implantation.
• Safety and effectiveness of the XIENCE Family of stents have not been established for subject populations with the following clinical settings:Everolimus has been shown to reduce the clearance of some prescription medications when administered orally along with cyclosporine (CsA). Formal drug interaction studies have not been performed with the XIENCE Family of stents because of limited systemic exposure to everolimus eluted from the stent.
  • Patients with prior target lesion or in-stent restenosis related brachytherapy, patients in whom mechanical atherectomy devices or laser angioplasty catheters are used in conjunction with XIENCE Family stents, women who are pregnant or lactating, men intending to father children, pediatric patients, unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.25 mm or > 4.25 mm or lesion length > 32 mm, lesions located in saphenous vein grafts, unprotected left main coronary artery, ostial lesions, lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent acute myocardial infarction (AMI) or evidence of thrombus in target vessel multivessel disease, and in-stent restenosis
• Everolimus is an immunosuppressive agent. Consideration should be given to patients taking other immunosuppressive agents or who are at risk for immune suppression.
• Oral everolimus use in renal transplant patients and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglycerides, which in some cases required treatment.
• Nonclinical testing has demonstrated that the XIENCE Family of stents, in single and in overlapped configurations are MR conditional up to 68 mm in length for XIENCE V and XIENCE nano only and up to 71 mm in length for all other XIENCE Family stents. It can be scanned safely under the conditions in the Instructions for Use.
• The XIENCE Family of stents should be handled, placed, implanted, and removed according to the Instructions for Use.