FAQ About XIENCE™ Stent
What about magnetic resonance imaging (MRI) safety with XIENCE™ Stents?2
Nonclinical testing has shown that the XIENCE Skypoint™ and XIENCE Sierra™ Stents, in single and in overlapped configurations up to 91 mm and 71 mm in length respectively, are MR conditional. A patient with a XIENCE™ Stent 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 (30 T/m)
- 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™ Stents are expected to produce a maximum temperature rise of of less than 4.8°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 6 mm from the XIENCE™ 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™ Stents.
Refer to the Instructions For Use (IFU) for additional information.
How does XIENCE Skypoint™ Stent differ from previous generations of XIENCE™ DES?
XIENCE Skypoint™ Stent offers these features:
- Increased post dilatation maximum expansion to 5.75 mm for 3.5 mm and 4.0 mm diameters2
- No shortening at maximum post dilatation maximum at 5.75 mm3
- Ultra-low stent profile of 0.039" allows for easier crossing of difficult lesions3
- Best in class deliverability while expending less force across lesions3
- XIENCE Skypoint™ Stent provides a broader size matrix with 4.5 mm, 5.0 mm stent diameters and 48 mm lengths2
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 is the dual antiplatelet therapy (DAPT) duration with XIENCE™ Stents?
With more than 30,000 XIENCE™ DES patients analyzed in DAPT studies,4 Abbott has received a 1-month DAPT CE indication for High Bleeding Risk patients.2
In addition, the STOPDAPT, STOPDAPT-2, STOPDAPT-3, XIENCE 28 and XIENCE 90 trials reported consistently low ST rates when DAPT was discontinued after 1 or 3 months.4 (XIENCE 28, STOPDAPT, STOPDAPT-2 and XIENCE 90 results at 12 months). Learn more about DAPT.
* The effects of MRI on overlapped stents greater than 71 mm in length, or involving stents with fractured struts, are unknown.
References
- 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.
- XIENCE Skypoint™ and XIENCE Sierra™ Stent Instructions for Use (IFU). Refer to IFUs for additional information.
- Data on file at Abbott.
- Mehran R, et al. TCT Connect 2020 – XIENCE 28/90. Watanabe H, et al. JAMA. 2019;321(24):2414-2427. Hahn J, et al. ACC 2019 – SMART CHOICE. Varenne O, et al. Lancet. 2018.391:41-50 – SENIOR. Kirtane A, et al. TCT 2019 – EVOLVE Short DAPT. Kedhi E, et al. PCT eCourse 2020 – OnyxOne; Postma W, et al. Cather Cardiovasc Interv. 2020;95:706-710 – DAPT-STEMI. Valgimigli, M., et al. NEJM. 2021;10.1056. Natsuaki, M., et al. AHA. 2023;1:49:00
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