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:*
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.
XIENCE Sierra™ Stent offers these features:3
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
|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|
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:
Thus the XIENCE™ fluoropolymer was created to ensure long-term protection to the vessel and ultimately to the patient.
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.
* The effects of MRI on overlapped stents greater than 71 mm in length, or involving stents with fractured struts, are unknown.
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