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Coronary Drug Eluting Stents

XIENCE Everolimus Eluting Coronary Stent System

Indications & Important Safety Information ›› IFU (Full Version) ››
 

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Healthcare Professionals

Smooth


Abbott Vascular is pleased to announce the market release of XIENCE Xpedition, the most agile XIENCE. Ever.

XIENCE Xpedition consists of a groundbreaking NEW stent delivery system and the proven XIENCE implant. It is available in a full Rapid Exchange and OTW size matrix, including the unique 3.25 mm diameter for accurate sizing.

XIENCE Safety

XIENCE

The MULTI-LINK platform, biocompatible coating technology and low-dose everolimus continue to offer the trusted XIENCE safety profile.

The XIENCE Xpedition drug eluting stent offers XIENCE Safety:

  • Largest Body of Clinical Data1
  • Consistently Low Stent Thrombosis Rates. Trial After Trial.
  • Proven Stent Design.

Smooth Tracking

The brand new, XIENCE Xpedition stent delivery system is optimized for acute performance.

The XIENCE Xpedition drug eluting stent offers Smooth Tracking:

  • Zero transition integrated tip design for smooth tracking
  • Thinner and stronger multi-layer balloon for safe, successful deployment
  • Optimized materials for smooth tracking in challenging anatomy

1.Based on patient numbers from various Abbott and non-Abbott-sponsored trials. Data on file at Abbott Vascular

Additional Information

Magnetic Resonance Imaging (MRI) and Intracoronary Stents

Additional information about the safety of performing MRI following the placement of a XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent.

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Additional information about the safety of performing MRI following the placement of a XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent.

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Metal Allergy Testing

Information regarding allergy testing for 316L stainless steel and L605 cobalt chromium.

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Rubber Latex - XIENCE Everolimus Eluting Coronary Stent

Letter addressing latex materials and the XIENCE Everolimus Eluting Coronary Stent.

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Cobalt Chromium - XIENCE Everolimus Eluting Coronary Stent

Information about XIENCE's cobalt chromium alloy, including low nickel content.

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Polyvinyl Chloride (PVC) - XIENCE Everolimus Eluting Coronary Stent

Letter explaining that Abbott Vascular products do not contain polyvinyl chloride.

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Allergy Letter
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Hospital Administrators


XIENCE represents the true potential of a next-generation drug eluting stent. Combining Abbott's strong legacy of leadership and innovation with excellent service and support, XIENCE delivers a solution that you can deploy with confidence.

Abbott Vascular is committed to providing you with the best possible customer service. Below are resources to assist you in the treatment of vascular disease.

Have questions? We have answers.

  • Customer Service: Call 1-800-227-9902 or fax 1-800-601-8874 or email av.customercare@av.abbott.com. Operating hours Mon-Fri 5am-5pm PST with 24/7 live personnel emergency after hour support.
  • Reimbursement Questions: Go online to the Reimbursement Resource or call 1-800-354-9997 (Mon-Fri, 9 AM-5 PM CST)
  • GHX Supply Chain Services: Go to www.ghx.com
 instructions for use XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Instructions for Use

 

This document provides XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Instructions for Use for the United States only.

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 instructions for use XIENCE V and XIENCE nano Instructions for Use

 

This document provides XIENCE V and XIENCE nano Instructions For Use for the United States only.

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 instructions for use XIENCE PRIME and XIENCE PRIME LL Instructions for Use

 

This document provides XIENCE PRIME and XIENCE PRIME LL Instructions for Use for the United States only.

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XIENCE bar codes  US XIENCE V Product Numbers and Bar Codes

 

Easily locate XIENCE V bar codes to order products and confirm inventory.

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XIENCE PRIME bar codes  US XIENCE PRIME and XIENCE PRIME LL Product Numbers and Bar Codes

 

Easily locate XIENCE PRIME and XIENCE PRIME LL bar codes to order products and confirm inventory.

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 product catalog  Abbott Vascular Product Catalog

 

Review all products offered by Abbott Vascular.
Product Catalogs for Download

 product catalog  US Patient Information Guide

 

Ensure that patients have information about CAD and the XIENCE Family of stent systems. The XIENCE Patient Information Guide illustrates the stent procedure and outlines the risks and benefits of treating with XIENCE.

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Resources from Abbott

Education and Training

Information about educational programs on new therapies and treatments.

Reimbursement

Coding, coverage, and payment information for Abbott medical technologies.

AP2932900-US Rev. A

 

Indications and Important Safety Information

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The XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE XpeditionTM, XIENCE XpeditionTM SV and XIENCE XpeditionTM LL (XIENCE Family) of Everolimus Eluting Coronary Stents on the MULTI-LINK VISION® or MULTI-LINKMINI VISION® Delivery Systems

 

 

INDICATIONS

The XIENCE Family of Everolimus Eluting Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (XIENCE V, XIENCE nano and XIENCE Xpedition SV length ≤ 28 mm and XIENCE PRIME, XIENCE PRIME LL, XIENCE Xpedition and XIENCE Xpedition LL length ≤ 32 mm) with reference vessel diameters of 2.25 mm to 4.25 mm.

 

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 device use has been associated with 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 Use for 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:
  • Patients with prior target lesion or in-stent restenosis related brachytherapy, patients in whom mechanical atherectomy devices or laser angioplasty devices are used simultaneously, 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, chronic total occlusions, 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, moderate or severe lesion calcification, multivessel disease, and in-stent restenosis
    • Everolimus has been shown to reduce the clearance of some prescription medications when it was 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.
    • 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.
    • Non-clinical testing has demonstrated that the XIENCE Family of stents, in single and in overlapped configurations up to 68 mm in length for XIENCE V and XIENCE nano and up to 71 mm in length for XIENCE PRIME, XIENCE PRIME LL, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL are MR Conditional. 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.

 

POTENTIAL ADVERSE EVENTS

Adverse events (in alphabetical order) which may be associated with coronary stent use in native coronary arteries include but are not limited to:

  • Abrupt closure, Access site pain, hematoma, or hemorrhage, Acute myocardial infarction, Allergic reaction or hypersensitivity to contrast agent or cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers; and drug reactions to antiplatelet drugs or contrast agent, Aneurysm, Arterial perforation and injury to the coronary artery, Arterial rupture, Arteriovenous fistula, Arrhythmias, atrial and ventricular, Bleeding complications, which may require transfusion, Cardiac tamponade, Coronary artery spasm, Coronary or stent embolism, Coronary or stent thrombosis, Death, Dissection of the coronary artery, Distal emboli (air, tissue or thrombotic), Emergent or non-emergent coronary artery bypass graft surgery, Fever, Hypotension and / or hypertension, Infection and pain at insertion site, Injury to the coronary artery, Ischemia (myocardial), Myocardial infarction (MI), Nausea and vomiting, Palpitations, Peripheral ischemia (due to vascular injury), Pseudoaneurysm, Renal Failure, Restenosis of the stented segment of the artery, Shock/pulmonary edema, Stroke / cerebrovascular accident (CVA), Total occlusion of coronary artery, Unstable or stable angina pectoris, Vascular complications including at the entry site which may require vessel repair,  Vessel dissection

Adverse events associated with daily oral administration of everolimus to organ transplant patients include but are not limited to:

  • Abdominal pain (including upper abdominal pain); Anemia; Angioedema; Anorexia; Asthenia; Constipation; Cough; Delayed wound healing/fluid accumulation; Diarrhea; Dyslipidemia (including hyperlipidemia and hypercholesterolemia); Dyspnea; Dysgeusia; Dyspepsia; Dysuria; Dry skin; Edema (peripheral); Epistaxis; Fatigue; Headache; Hematuria; Hyperglycemia (may include new onset of diabetes); Hyperlipidemia; Hyperkalemia; Hypertension; Hypokalemia; Hypomagnesemia; Hypophosphatemia; Increased serum creatinine; Infections and serious infections: bacterial, viral, fungal, and protozoal infections (may include herpes virus infection, polyoma virus infection which may be associated with BK virus associated nephropathy, and/or other opportunistic infections); Insomnia; Interaction with strong inhibitors and inducers of CY3PA4; Leukopenia; Lymphoma and other malignancies (including skin cancer); Male infertility (azospermia and/or oligospermia); Mucosal inflammation (including oral ulceration and oral mucositis); Nausea; Neutropenia; Non-infectious pneumonitis; Pain: extremity, incision site and procedural, and back; Proteinuria; Pruritus; Pyrexia; Rash; Stomatitis; Thrombocytopenia; Thrombotic microangiopathy (TMA)/Thrombotic thrombocytopenic purpura (TTP)/ Hemolytic uremic  syndrome (HUS); Tremor; Urinary tract infection; Upper respiratory 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.

 

Prior to use, please reference the Instructions for Use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions, and adverse events.

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