Frequently Asked Questions About XIENCE

What about magnetic resonance imaging (MRI) safety with XIENCE?

Nonclinical testing has shown that the XIENCE Alpine stent, in single and in overlapped configurations up to 71 mm in length, can be safely scanned under the following conditions:*

  • Static magnetic field of 1.5 or 3 Tesla
  • Spatial gradient field of 2500 Gauss/cm or less
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for up to 15 minutes of scanning for each sequence

    
The XIENCE Alpine stent should not migrate in this MRI environment. MRI at 1.5 or 3 Tesla may be performed immediately post-implantation.

At the tested parameters noted above, the XIENCE Alpine stent produced a nonclinical maximum local temperature increase of 3.3°C. This does not take into consideration the cooling effects of blood flow.

An image artifact can be present, and MRI image quality may be compromised if the area of interest is at or near the stent position. Therefore, it may be necessary to optimize the MRI parameters to account for the presence of the XIENCE drug-eluting stent.

Refer to the IFU for Additional Information.

How does XIENCE Sierra differ from previous generations of XIENCE?

A: XIENCE Sierra offers these features:

  • Increased post dilatation maximum expansion to 5.5 mm for 3.5 and 4.0 mm diameters#
  • 0% shortening even at maximum post dilatation maximum at 5.5 mm1
  • Ultra-low stent profile of 0.0390" allows for easier crossing of difficult lesions 
  • Best in class deliverability while expending less force across lesions (e.g., 73% less force than Synergy)

The ultra-low crossing profile allows users to choose XIENCE for the most challenging cases of coronary artery disease. XIENCE stents, in addition to being the most studied stents, produce consistently low stent thrombosis rates.

What are the sizes of frequently used XIENCE drug-eluting stents?

 

 

View ordering information here.

What are the unique properties of the XIENCE polymer?

The specific fluoropolymer used—based on years of research—plays a critical role in XIENCE's superior outcomes. Abbott successfully identified a polymer that offers both mechanical integrity and scientific evidence of biocompatibility. Extensive research showed that polymers with a fluorinated surface were associated with “protective” attributes, such as the ability to tightly bind albumin to create a “protective cloak” around the stent.2-5 This results in the following characteristics, collectively known as fluoropassivation:

  • Thromboresistance, referring to the preferential adsorption and retention of good protein (e.g., albumin) vs thrombogenic proteins (e.g., fibrinogen)—leading to less platelet adhesion and activation.2-5
  • Minimal inflammatory response,2 since the preferential adsorption of albumin minimizes platelet adhesion, leukocyte activation and leukocyte recruitment.
  • Functional healing, since preferential albumin adsorption elicits a cellular response conducive to healing, with rapid formation of functional endothelium and minimal chronic inflammation.2,6-7


Thus the XIENCE fluoropolymer was created to ensure long-term protection to the vessel and ultimately to the patient.

What is the dual antiplatelet therapy (DAPT) duration with XIENCE?

With more than 16,000 XIENCE patients involved in DAPT studies, Abbott has received a 1-month DAPT CE label update based on a pooled analysis examining early DAPT interruption/discontinuation  and stent thrombosis rates through 2 years in a large pooled sample of patients from the XIENCE family of clinical studies.8

In addition, the STOPDAPT trial9 revealed 0% definite or probable ST with XIENCE when DAPT was discontinued at 3 months. Learn more about DAPT.

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# Increased maximum expansion compared to other XIENCE Everolimus Eluting Coronary Stent System
1. Test performed by and data on file at Abbott. XIENCE Sierra Everolimus Eluting Coronary Stent System (4.0 x 18 mm) n=5, SYNERGY Stent System (4.0 x 20 mm) n=5, Resolute Onyx Stent System (4.5 x 18 mm) n=5.


 Bench test data shows that XIENCE Sierra performed better in crossability and was not statistically different in trackability and pushability compared to Resolute Onyx and SYNERGY stents. Bench test results may not necessarily be indicative of clinical performance. Test performed by and data on file at Abbott. Testing performed on XIENCE Sierra Everolimus Eluting Coronary Stent System (3.0 x 18 mm) n=5, SYNERGY Stent System (3.0 x 20 mm) n=5, Resolute Onyx Stent System (3.0 x 18 mm) n=5. Catheter performance crossability test measures average force to cross a challenging lesion model.

‡ Increased maximum expansion compared to other XIENCE Everolimus Eluting Coronary Stent System.

* The effects of MRI on overlapped stents greater than 71 mm in length, or involving stents with fractured struts, are unknown.

  1. Paton DM, et al. U.S. Patent 5,356,668.
  2. Garfinkle AM, et al. Trans Am Soc Artif Intern Organs. 1984;30:432-439.
  3. Fluorinated surfaces have been used for cardiovascular implants to benefit from thromboresistance and long-term biocompatibility.
  4. Ao PY, et al. Eur J Vasc Endovasc Surg. 2000;20:241-249. doi.org/10.1053/ejvs.2000.1177.
  5. Lilenfeld R, et al. U.S. Patent 4,564,013.
  6. Chinn JA, et al. J Biomed Mater Res. 1998;39:130-140.
  7. Généreux P, et al. Circ Cardiovasc Interv. 2015;8:e001362. doi:10.1161/CIRCINTERVENTIONS.114.001362.
  8. Natsuaki M, et al. STOPDAPT Trial. Cardiovasc Interv Ther. 2016;31:196–209.

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