INTRODUCING
XIENCE Sierra
™
With the safety you’ve
always relied on and the
deliverability you’ve always
wanted, choosing the right
stent is now an easier decision.
START
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 1 of 11
™
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 2 of 11
XIENCE SIERRA
™
REQUIRES 73% LESS FORCE TO CROSS
A LESION THAN SYNERGY
‡
AND 64% LESS FORCE THAN
RESOLUTE ONYX
‡
Best-in-Class Deliverability
1
1. Bench test data shows that XIENCE Sierra performed better in crossability and was not statistically dierent 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.
Average Force (gm)
0
5
10
15
20
25
30
Resolute
Onyx
‡
XIENCE
Sierra
™
SYNERGY
‡
up to 73% less force
LOWER IS BETTER
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 3 of 11
Thinner balloon provides
maximum flexibility and
further lowers crimped profile
Best-in-Class Deliverability
1
1. Bench test data shows that XIENCE Sierra performed better in crossability and was not statistically dierent 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.
2. Based on customer feedback on testing XIENCE Sierra in the Synthetic Anatomical Model developed by Abbott.
3. Test performed by and data on file at Abbott. 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.
SYNERGY
‡
0.0393"
Resolute
Onyx
‡
0.0401"
XIENCE
Alpine
™
0.0435"
XIENCE
Sierra
™
0.0390"
For Even the Most Challenging Lesions
2
ULTRA LOW STENT CROSSING PROFILE OF 0.039" FOR
EASIER CROSSING ENABLED BY THE NEW STENT DESIGN
AND BALLOON TECHNOLOGY
3
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 4 of 11
OPTIMIZED MULTI-LINK
™
STENT DESIGN ALLOWS FOR
TIGHTER CRIMPING AND SMOOTHER CROSSING
Best-in-Class Deliverability
1
SLIMMER, MORE
FLEXIBLE LINKS
NARROWER
CREST
*
1. 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.
*Comparative claims refer to XIENCE Alpine
™
stent as comparator.
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 5 of 11
Re-engineered delivery
system ensures consistent
force transmission for
outstanding pushability
Dislodgement (lbf ) Average
0
0.5
1.0
1.5
2.0
2.5
SYNERGY
‡
1.11
Resolute
Onyx
‡
0.67
XIENCE
Sierra
™
2.0
HIGHER IS BETTER
Best-in-Class Deliverability
1
Outstanding stent retention
2
for confident crossing of
challenging anatomy
1. Bench test data shows that XIENCE Sierra performed better in crossability and was not statistically dierent 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.
2. Test performed by and data on file at Abbott. 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.
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 6 of 11
UNIQUELY DESIGNED TO POST-DILATE TO 5.5 mm
Expanded Treatment Options
1
5.5 mm
Maximum
expansion for
3.5 mm and 4.0 mm
1. Increased maximum expansion compared to other XIENCE Everolimus Eluting Coronary Stent System.
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 7 of 11
ENSURES COATING INTEGRITY
2
EVEN AT MAX EXPANSION
Expanded Treatment Options
1
1. Increased maximum expansion compared to other XIENCE Everolimus Eluting Coronary Stent System.
2. Test performed by and images on file at Abbott.
XIENCE Sierra
™
(3.5 x 18 mm) 25x
magnification at max
expansion of 5.5 mm
XIENCE Sierra
™
(3.5 x 18 mm) 150x
magnification at max
expansion of 5.5 mm
SYNERGY
‡
(3.5 x 20 mm) 25x
magnification at max
expansion of 4.25 mm
SYNERGY
‡
(3.5 x 20 mm) 150x
magnification at max
expansion of 4.25 mm
Resolute Onyx
‡
(3.5 x 18 mm) 25x
magnification at max
expansion of 4.75 mm
Resolute Onyx
‡
(3.5 x 18 mm) 150x
magnification at max
expansion of 4.75 mm
SYNERGY
‡
coating shows
multiple cracks with
delamination at its
max expansion of
4.25 mm from
3.5 mm
Resolute Onyx
‡
coating peels o
and shows exposed
metal at its max
expansion of 4.75 mm
from 3.5 mm
XIENCE Sierra
™
coating remains
intact at maximum
post-dilatation
expansion of 5.5 mm
from 3.5 mm
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 8 of 11
PROVIDES UNSURPASSED PRECISION IN PLACEMENT
AND AVOIDS GEOGRAPHIC MISS
Expanded Treatment Options
1
ZERO shortening even at
max expansion to 5.5 mm
2
Shortening (%) average at
maximum expansion of 5.5 mm
4.8%
7.5%
Average Shortening (%)
0
5
10
Resolute
Onyx
‡
XIENCE
Sierra
™
SYNERGY
‡
0.0%
shortening
1. Increased maximum expansion compared to other XIENCE Everolimus Eluting Coronary Stent System.
2. 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.
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 9 of 11
XIENCE SHOWS CONSISTENTLY LOW STENT THROMBOSIS
RATES IN COMPLEX PATIENTS
2-7
Unparalleled Safety
1
*DAPT Duration of 1 month.
NOTE: Data dierences depicted between these trials may not be statistically significant or clinically meaningful and dierent clinical trials may include dierences in the patient populations.
1. XIENCE showed significant benefit compared to several DES and composite BMS in multiple large scale meta-analyses and other RCTs. Source: Palmerini, et al. The Lancet. 379:9824, 14-20 April 2012, pp. 1393-1402; Bangalore S, et al. Circ Cardiovasc Interv,
Aug 6, 2013. doi: 10.1161/circinterventions.113.000415; Valgimigli, Eects of Cobalt-chromium Everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events. A patient-level meta analysis. EuroPCR 2014; Serruys, PW, et al.
RESOLUTE All Comers Trial, NEJM 2010. Published online June 16, 2010; Fajadet, J., et al. PLATINUM PLUS 30-day Poster, TCT 2012. 2. Teeuwen, K. et al. “Hybrid Sirolimus-eluting Stents with Biodegradable Polymer versus Everolimus eluting
Stents with Durable Polymer in Chronic Total Occlusions (PRISON IV).” JACC Cardiovasc Interv. 2017; Jan 23; 10(2): 133-143. DOI:10.1016/j.jcin.2016.10.017. 3. U Kaul. Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic
population: two-year follow-up of the TUXEDO-India trial. EuroIntervention 2017: 13:1194-1201. 4. Watanable, H. et al. One-Month Dual Antiplatelet Therapy Followed by Clopidogrel Monotherapy versus Standard 12-Month Dual Antiplatelet
Therapy with Clopidogrel after Drug-Eluting Stent Implantation. STOPDAPT2 Trial. ACC 2019 Presentation. 5. Stone, G. First Presentation of the EXCEL 4-Year Outcomes TCT 2018 Presentation. 6. Lam, M. Three-year clinical outcome of patients
with bifurcation treatment with second-generation Resolute and XIENCE V stents in the randomized TWENTE trial. American Heart Journal. Vol 169: No 1, Jan 2015. 7. M. Sabaté. Everolimus-eluting stents versus bare metal stents in ST-segment
elevation myocardial infarction. Five-year results of the EXAMINATION Trial. Lancet, October 29, 2015. http://dx.doi.org/10.1016/S0140-6736(15)00548-6
SHORT DAPT*
Definite/Probable
Stent Thrombosis
at 1 year
4
0.3%
STEMI
Definite/Probable
Stent Thrombosis
at 5 years
7
2.0%
DIABETES
ARC Definite/Probable
Stent Thrombosis
at 2 years
3
0.4%
LEFT MAIN
Definite Stent
Thrombosis
at 4 years
5
1.1%
BIFURCATIONS
Definite/Probable
Stent Thrombosis
at 3 years
6
0.5%
CTO
Definite/Probable
Stent Thrombosis
at 1 year
2
0.7%
Information contained herein for distribution outside the U.S. only.
Check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B Page 10 of 11
Ordering Information
STENT SPECIFICATIONS
Stent Design
MULTI-LINK
™
, 3-3-3,
Nonlinear Link
Stent Material L-605 Cobalt Chromium
Drug Everolimus
Drug Dose 1 µg/mm
2
Polymer Fluorinated Copolymer
Strut Thickness 0.0032"
MRI Compatibility
MR Conditional
(see IFU for specific conditions)
Shortening 0% (nominal expansion)
Post-Dilatation Limit
Sizes
2.0-3.25 mm
3.5-4.0 mm
Post-Dil Limit
3.75 mm
5.5 mm
DELIVERY SYSTEM SPECIFICATIONS
Nominal Pressure
9 atm for 2.0-2.5 mm;
12 atm for 2.75-4.0 mm
Rated Burst Pressure 16 atm for All Diameters
Shaft Measurements
Proximal
2.1F/0.71 mm
Distal
2.7F/0.89 mm
Min. GC/Sheath Diameter 5F/0.056"/1.42 mm
Balloon Material Pebax
‡
72D
Crossing Profile 0.039" (3.0 x 18 mm)
Tip Entry Profile 0.017" (3.0 x 18 mm)
Working Catheter Length 145 cm
STENT
DIAMETER
LENGTH
POST-
DILATATION
LIMIT
8 mm 12 mm 15 mm 18 mm 23 mm 28 mm 33 mm 38 mm
2.0 mm 1500200-08 1500200-12 1500200-15 1500200-18 1500200-23 1500200-28 1500200-33 1500200-38 3.75 mm
2.25 mm 1500225-08 1500225-12 1500225-15 1500225-18 1500225-23 1500225-28 1500225-33 1500225-38 3.75 mm
2.5 mm 1500250-08 1500250-12 1500250-15 1500250-18 1500250-23 1500250-28 1500250-33 1500250-38 3.75 mm
2.75 mm 1500275-08 1500275-12 1500275-15 1500275-18 1500275-23 1500275-28 1500275-33 1500275-38 3.75 mm
3.0 mm 1500300-08 1500300-12 1500300-15 1500300-18 1500300-23 1500300-28 1500300-33 1500300-38 3.75 mm
3.25 mm 1500325-08 1500325-12 1500325-15 1500325-18 1500325-23 1500325-28 1500325-33 1500325-38 3.75 mm
3.5 mm 1500350-08 1500350-12 1500350-15 1500350-18 1500350-23 1500350-28 1500350-33 1500350-38 5.50 mm
4.0 mm 1500400-08 1500400-12 1500400-15 1500400-18 1500400-23 1500400-28 1500400-33 1500400-38 5.50 mm
Expanded
sizes*
*Expanded sizes as compared to XIENCE Alpine
™
.
CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product
carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications,
Warnings, Precautions and Adverse Events. Information contained herein for DISTRIBUTION outside the U.S. only. Check the regulatory status
of the device in areas where CE marking is not the regulation in force.
Tests performed by and data on file at Abbott.
Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.
Abbott International BVBA
Park Lane, Culliganlaan 2B, 1831 Diegem, Belgium, Tel: 32.2.714.14.11
™ Indicates a trademark of the Abbott Group of Companies.
‡
Indicates a third-party trademark, which is property of its respective owner.
www.cardiovascular.abbott
©2019 Abbott. All rights reserved. AP2944678-OUS Rev. B
