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FAQ About Xience™ Stent

What about magnetic resonance imaging (MRI) safety with XIENCE™ Stents?2

Nonclinical testing has shown that the XIENCE Sierra™ Stent, in single and in overlapped configurations up to 71 mm in length, are MR conditional. A patient with this device can be scanned in an MR system under the following conditions:*

  • Static magnetic field of 1.5 or 3 Tesla
  • Maximum spatial gradient field of 3000 Gauss/cm or less
  • Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

Under the scan conditions defined above, XIENCE Sierra™ Stents are expected to produce a maximum temperature rise of of less than 4.5°C after 15 minutes of continuous scanning.

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

In non-clinical testing, the image artifact caused by the device extends approximately 6 mm from the XIENCE Sierra™ Stent when imaged with a gradient echo or spin echo pulse sequence and a 3T MRI system. It may be necessary to optimize the MRI parameters to account for the presence of XIENCE Sierra™ Stents.

Refer to the IFU for additional information.

How does XIENCE Sierra™ Stent differ from previous generations of XIENCE™ DES?

XIENCE Sierra™ Stent offers these features:3

  • Increased post dilatation maximum expansion to 5.5 mm for 3.5 and 4.0 mm diameters
  • No shortening at maximum post dilatation maximum at 5.5 mm
  • 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™ Stent for the most challenging cases of coronary artery disease. XIENCE™ Stents, in addition to being the most studied stents, produce consistently low stent thrombosis (ST) rates.1

What are the stent sizes and ordering information for XIENCE Sierra™ drug-eluting stents?

Stent Diameter 8-mm Length 12-mm Length 15-mm Length 18-mm Length Post-Dilatation Limit
2.0 mm 1500200-08 1500200-12 1500200-15 1500200-18 3.75 mm
2.25 mm 1500225-08 1500225-12 1500225-15 1500225-18 3.75 mm
2.5 mm 1500250-08 1500250-12 1500250-15 1500250-18 3.75 mm
2.75 mm 1500275-08 1500275-12 1500275-15 1500275-18 3.75 mm
3.0 mm 1500300-08 1500300-12 1500300-15 1500300-18 3.75 mm
3.25 mm 1500325-08 1500325-12 1500325-15 1500325-18 3.75 mm
3.5 mm 1500350-08 1500350-12 1500350-15 1500350-18 5.50 mm
4.0 mm 1500400-08 1500400-12 1500400-15 1500400-18 5.50 mm

 

Stent Diameter 23-mm Length 28-mm Length 33-mm Length 38-mm Length Post-Dilatation Limit
2.0 mm 1500200-23 1500200-28 1500200-33 1500200-38 3.75 mm
2.25 mm 1500225-23 1500225-28 1500225-33 1500225-38 3.75 mm
2.5 mm 1500250-23 1500250-28 1500250-33 1500250-38 3.75 mm
2.75 mm 1500275-23 1500275-28 1500275-33 1500275-38 3.75 mm
3.0 mm 1500300-23 1500300-28 1500300-33 1500300-38 3.75 mm
3.25 mm 1500325-23 1500325-28 1500325-33 1500325-38 3.75 mm
3.5 mm 1500350-23 1500350-28 1500350-33 1500350-38 5.50 mm
4.0 mm 1500400-23 1500400-28 1500400-33 1500400-38 5.50 mm

What are the unique properties of the XIENCE™ DES fluoropolymer?

The specific fluoropolymer used—based on years of research—plays a critical role in XIENCE™ Stent'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.4 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.
  • Minimal inflammatory response,8 since the preferential adsorption of albumin minimizes platelet adhesion, leukocyte activation and leukocyte recruitment.
  • Functional endothelialization, since preferential albumin adsorption elicits a cellular response conducive to healing, with rapid formation of functional endothelium and minimal chronic inflammation.5

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™ Stents?

With more than 24,000 XIENCE™ DES patients analyzed in DAPT studies,6 Abbott has received a 1-month DAPT CE indication for High Bleeding Risk patients.

In addition, the STOPDAPT, STOPDAPT 2, XIENCE 28 and XIENCE 90 trials reported consistently low ST rates when DAPT was discontinued after 1 or 3 months.7 (XIENCE 28, STOPDAPT, STOPDAPT 2 and XIENCE 90 results at 12 months). Learn more about DAPT.

  • Manuals & Technical Resources
  • Cardiovascular Products
  • Customer Service

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

References

  1. Zanchin C, et al. JACC Cardiovasc Interv. 2019;12(17):1665-1675. Serruys P, et al. N Engl J Med. 2010;363:136-146. 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. 2013;379:1393-1402. Bangalore S, et al. Circulation. 2012;125:2873-2891. Bangalore S, et al. Circ Cardiovasc Interv. 2013;6(6):378-390. Pilgrim T, et al. Lancet. 2014;384:2111-2122. Pilgrim T, et al. Lancet. 2018;392:737-746. Data on file at Abbott.
  2. Instructions for Use, XIENCE Sierra™ Stent.
  3. Tests performed by and data on file at Abbott. Increased maximum expansion compared XIENCE Sierra™ Stent with XIENCE Alpine™ Stent. Shortening compared XIENCE Sierra™ Stent (4.0 x 18 mm, n=5), SYNERGY (4.0 x 20 mm, n=5), Resolute Onyx (4.5 x 18 mm, n=5). Crossing data showed that XIENCE Sierra™ stent 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. Testing performed on XIENCE Sierra™ Stent (3.0 x 18 mm, n=5), SYNERGY (3.0 x 20 mm, n=5), Resolute Onyx (3.0 x 18 mm, n=5). Catheter performance crossability test measures average force to cross a challenging lesion model.
  4. Garfinkle AM, et al. Trans Am Soc Artif Intern Organs. 1984;30:432-439. Ao PY, et al. Eur J Vasc Endovasc Surg. 2000;20:241-249. Jinnouchi H, et al. EuroIntervention. 2020;10:EIJ-D-19-00938
  5. Garfinkle AM, et al. Trans Am Soc Artif Intern Organs. 1984;30:432-439. Chinn JA, et al. J Biomed Mater Res. 1998;39:130-140. Généreux P, et al. Circ Cardiovasc Interv. 2015;8:e001362.
  6. Généreux P, et al. Circ Cardiovasc Interv. 2015;8: e001362. Natsuaki M, et al. Cardiovasc Interv and Ther. 2016. 31:196–209. Watanabe H, et al. JAMA. 2019;321(24):2414-2427. Hahn J, et al. ACC 2019, SMART CHOICE. Valgimigli M, et al. Circulation. 2012;125:2015-2026. Gilard M, et al. J Am Coll Cardiol. 2015;65:777-786, Hong SJ, et al. JACC Cardiovasc Interv. 2016;9:1438–1446. Gwon HC, et al. ACC 2011, EXCELLENT. Mehran R, et al. TCT Connect 2020, XIENCE 28/90.
  7. Natsuaki M, et al., Cardiovasc Interv and Ther. 2016. 31:196–209; Watanabe H, et al. JAMA. 2019;321(24):2414-2427. Mehran R, et al. TCT Connect 2020, XIENCE 28/90. Valgimigli M, et al. ACC 2021, XIENCE 28/90.
  8. Jinnouchi H, et al. J Am Coll Cardiol. 2019;74:Suppl B - TCT-291.

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