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CARDIOVASCULAR
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The XIENCE™ DES is proven to offer unparalleled patient outcomes during and long after percutaneous coronary interventions (PCI).1 Implanted in over 15 million patients and studied in 120+ clinical trials,* XIENCE™ Stent provides consistent long-term safety data beyond 10 years.2 XIENCE™ Stent allows interventional cardiologists (ICs) to achieve the positive outcomes they want for their patients.

Reach for Xience

XIENCE Sierra™ Drug Eluting Stent System

The newest DES in the XIENCE™ Family, XIENCE Sierra™ Stent has an enhanced design that offers exceptional deliverability, pushability, post dilatation expansion as well as an ultra-low profile and smoother crossing.

XIENCE Alpine™ Everolimus Eluting Coronary Stent System

XIENCE Alpine™ Stent, like all XIENCE™ Stents, features a unique combination of design, drug, and fluoropolymer—with the fluoropolymer coating shown to be significantly more anti-thrombotic than other DES.3

* Data on file at Abbott. The 15 million implants is based on DES data through Q1 2020.

† Tests performed by and data on file at Abbott.

References

  1. Zanchin C, et al. JACC Cardiovasc Interv. 2019;12(17):1665-1675. • Serruys P, et al. N Engl J Med. 2010;363(2):136-146. • Shiomi H, et al.  JACC Cardiovasc Interv. 2019;12:637-647. • Kufner S, et al. Circulation. 2019:139(3):325-333. • Palmerini T, et al. Lancet. 2012;379(9824);1393-1402. • Bangalore S, et al. Circ Cardiovasc Interv. 2013;6:378-390. • Pilgrim T, et al. Lancet. 2014;384:2111-2122. • Pilgrim T, et al. Lancet 2018;392:737-746.
  2. Kufner S, et al. Circulation. 2019:139(3):325-333. Shiomi H, et al. J Am Coll Cardiol Interv. 2019;12:637-647.
  3. Jinnouchi H, et al. J Am Coll Cardiol. 2019;74:Suppl B – TCT-291.
Important Safety Information

Important Safety Information

rx-only-logo XIENCE SIERRA™, XIENCE ALPINE™ (XIENCE™ FAMILY) EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

 

The XIENCE™ Family of Stents is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are indicated for treating de novo chronic total coronary occlusions.

Contraindications

The XIENCE™ Family of Stents is contraindicated for use in:

  • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.
  • Patients with hypersensitivity or contraindication to everolimus or structurally related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), or with contrast sensitivity.

Warnings

  • Each stent is for single use only. Do not resterilize or reuse this device. Note the “Use by” (expiration) date on product label.
  • It is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon.
  • Antiplatelet therapy should be administered post-procedure.
  • This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.
  • 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.

Precautions

  • To confirm sterility has been maintained, ensure that the inner package sterile barrier has not been opened or damaged prior to use.
  • Implantation of the stent should be performed only by the physicians who have received appropriate training.
  • Stent placement should be performed at centers where emergency coronary artery bypass graft surgery (CABG) is available.
  • Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcome following repeat dilatation of the stent is unknown at present.
  • 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.
  • When the XIENCE™ Family of Stents are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of clinical trials.
  • Compared to use within the specified Indications for Use, the use of the XIENCE™ Family of Stents 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.
  • The extent of the patient’s exposure to drug and polymer is directly related to the number of implanted stents. See Instructions for Use for current data on multiple stent implantation.
  • Safety and effectiveness of the XIENCE™ Family of Stents has not been established for subject populations with the following clinical settings:
    • Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis.
    • Conjunctive use of the XIENCE™ Family of Stents with either mechanical atherectomy devices or laser angioplasty catheters.
    • Women who are pregnant or lactating, men intending to father children, pediatric.
    • 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 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 Sierra™ or XIENCE Alpine™ Stents because of limited systemic exposure to everolimus eluted from XIENCE Sierra™ and XIENCE Alpine™ Stents.
    • 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 triglyceride levels, which in some cases required treatment.
    • Non-clinical testing has demonstrated that the XIENCE™ Family of Stents, in single and in overlapped configurations up to 71 mm in length, is MR Conditional. See Instructions for Use for detailed scanning conditions.

Potential Adverse Events

Adverse events (in alphabetical order) which may be associated with PCI treatment procedures and the use of a coronary stent in native coronary arteries include, but are not limited to, the following:

  • Allergic reaction or hypersensitivity to latex, contrast agent anesthesia, device materials, and drug reactions to everolimus, anticoagulation, or antiplatelet drugs • Vascular access complications which may require transfusion or vessel repair, including: Catheter site reactions, Bleeding, Arteriovenous fistula; pseudoaneurysm, dissection, perforation/rupture, Embolism, Peripheral nerve injury, Peripheral ischemia • Coronary artery complications which may require additional intervention, including: Total occlusion or abrupt closure, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection. Perforation/rupture, Tissue prolapse/plaque shift, Embolism, Coronary or stent thrombosis, Stenosis or restenosis • Pericardial complications which may require additional intervention, including: Cardiac tamponade, Pericardial effusion, Pericarditis. • Cardiac arrhythmias • Cardiac ischemic conditions (including myocardial ischemia, yocardial infarction (including acute), coronary artery spasm, and unstable or stable angina pectoris) • Stroke/Cerebrovascular Accident (CVA) and Transient Ischemic Attack (TIA) • System organ failures: Cardio-respiratory arrest, Cardiac failure, Cardiopulmonary failure, Renal Insufficiency/failure, Shock • Blood cell disorders • Hypotension and/or hypertension • Infection • Nausea and vomiting • Palpitations • Chest Pain • Fever • Pain • Death

The risks described below include, but are not limited to, the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings, and precautions sections of the everolimus labels.

  • Abdominal pain • Anemia • Angioedema • Anorexia • Asthenia • Constipation • Cough • Diarrhea • Dyslipidemia • Dysgeusia • Dyspepsia • Dyspnea • Dysuria • Dry Skin • Edema • Epistaxis • Fatigue • Headache • Hematuria • Hyperglycemia • Hyperkalemia • Hyperlipidemia • Hypertension • Hypokalemia • Hypomagnesemia • Hypophosphatemia • Increased serum creatinine • Infections and serious infections: bacterial, viral, fungal, and protozoal infections • Insomnia • Interaction with strong inhibitors and inducers of CYP3A4 or PgP • Leukopenia • Lymphoma and other malignancies (including skin cancer) • Male infertility • Mucosal inflammation • Nausea • Neutropenia • Non-infectious pneumonitis • Pain: extremity, incision site and procedural, back, chest, musculoskeletal • Proteinuria • Pruritus • Pyrexia • Rash • Stomatitis • Thrombocytopenia • Thrombotic microangiopathy • Tremor • Upper respiratory tract infection • Urinary tract infection • Vomiting

Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time.

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