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Patients Are Complex, Choosing A Stent Shouldn’t Be

As the world’s leading drug-eluting stent (DES), XIENCE™ Stent has twice as many implants as any other DES: more than 13,000,000 and counting.§ Physicians rely on XIENCE™ Stents as the gold standard for their patients. XIENCE Sierra™ Stent, with enhanced design modifications for exceptional crossing and deliverability*, provides long-term, unparalleled safety1-9—even with complex percutaneous coronary intervention (PCI).

OVERVIEW
PRODUCT ENHANCEMENTS
BEST-IN-CLASS DELIVERABILITY
UNPARALLELED SAFETY
EXPANDED TREATMENT OPTIONS
ORDERING INFO

Features at a Glance

XIENCE Sierra™ Stent features include latest, improved design elements.*

 

XIENCE Sierra™ stent with thin balloon

Continuing To Set Standards For Safety And Expanded Use

Interventional cardiologists choose XIENCE™ Stents more than any other DES.§ XIENCE Sierra™ Stent provides performance enhancements as follows:

 

Best-in-Class Deliverability

Among the features that position XIENCE Sierra™ Stent at the top of its class:

  • Requires less force than competitors to cross the same lesion*
  • Has an ultra-low stent crimped profile of 0.0390" for crossing tight lesions*
Unparalleled Safety

A few examples of XIENCE™ Stent’s safety include:

  • Low rates of stent thrombosis11-16
  • Low metal-to-artery ratio reduces injury and/or inflammation10
  • Fluoropolymer for thromboresistance17
Expanded Treatment Options

XIENCE Sierra™ Stent enhances treatment of challenging cases with more sizes and greater post-dilatation expansion than previous generations of XIENCE™ Stent*:

  • Long, tapered lesions*
  • Bifurcations*
  • Highly calcified lesions*
  • References

    § 13,000,000 implants number is based on data of DES implants through Q4 2018. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe, and Korea. Other leading DES: BSX stents (Promus Element‡, Promus Element Plus‡, Promus Premier‡, SYNERGY‡); MDT stents (Resolute‡, Resolute Integrity‡, Resolute Onyx‡); Terumo stents (Nobori‡, Ultimaster‡); Biotronik stent (Orsiro‡); and Biosensors stent (BioMatrix‡). Data on file at Abbott.

    * Tests performed by and data on file at Abbott:

    • Enhanced design statement is in comparison to XIENCE Alpine™ Stent.
    • Catheter performance crossability refers to testing performed on XIENCE Sierra™ Stent (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5. Catheter performance crossability test measures average force to cross a challenging lesion model. 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.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent Systems.
    • Expanded treatment options with post-dilation expansion up to 5.5 mm (3.5-4.0 mm) and more complete size matrix for long tapered lesions. Side branch accessibility with workhorse diameter (3.0 x 18 mm) to treat bifurcations. Enhanced radial strength in workhorse sizes for highly calcified lesions (compared to previous generations).
    • Ultra-low stent crimped profile of 0.0390" refers to XIENCE Sierra™ Stent profile size of (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5.
    • Shortening statement refers to testing performed on a 4.0 mm diameter stent deployed to 5.5 mm. XIENCE Sierra™ Stent (4.0 x 18 mm) n=5, Synergy‡ Stent (4.0 x 20 mm) n=5, Resolute Onyx‡ Stent (4.5 x 18 mm) n=5, Orsiro‡ Stent (4.0 x 18 mm) n=5.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent System.
    • Retention testing is measured by dislodgement (lbf) average.

    1. Serruys, PW et al. RESOLUTE All Comers Trial, 1-Yr Results Presentation, EuroPCR 2010.
    2. Fajadet, PLATINUM PLUS, TCT 2012.
    3. Smits P, et al. Abluminal biodegradable polymer BES vs. durable polymer EES (COMPARE II): a randomised, controlled, non-inferiority trial, The Lancet, dx.doi.org/10.1016/S0140-6736(12)61852-2, Jan 2013.
    4. Saito, S et. al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial, European Heart Journal, May 2014.
    5. Pilgrim, T; Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE); Lancet. 2014.
    6. Natsuaki, M ; Two-year Outcome NEXT; ACC 2014.
    7. Pilgrim, T; Device and Clinical Program Highlights: Orsiro; TCT 2015.
    8. Windecker S, RESOLUTE All-Comers 5-Year Presentation, EuroPCR 2014.
    9. Smits; The Final 5 Year Results From The COMPARE II trial; PCR 2016.
    10. Stone, G . EXCEL: a prospective, randomized trial comparing everolimus-eluting stents and bypass graft surgery in selected patients with left main coronary artery disease. TCT 2018.
    11. Teeuwen, K. et al. Randomized multicenter trial investigating angiographic outcomes of hybrid sirolimus-eluting stents with biodegradable polymer compared with everolimus-eluting stents with durable polymer in chronic total occlusions (PRISON IV). JACC Cardiovasc Interv. 2017;10(2):133-143. doi:10.1016/j.jcin.2016.10.017.
    12. Lam, M. Three year clinical outcome of patients with bifurcation treatment with second-generation Resolute and XIENCE V stents in the randomized TWENTE Trial. Am Heart J. 2015;169.
    13. Kaul U, et al. 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.
    14. Sabaté M, et al. EXAMINATION Trial. Lancet. 2016;387;357-366.
    15. Watanable, H. et al. Effect of 1-month dual antiplatelet therapy followed by clopidogrel vs 12-month dual antiplatelet therapy on cardiovascular and bleeding events in patients receiving PCI: STOPDAPT2 Trial. JAMA. 2019;321(24):2414-2427. doi:10.1001/jama.2019.8145.
    16. Panchalingam V, et al. ASAIO J. 1993;39:M305-M309.

Design Improvements With XIENCE Sierra™

These are a few of the modifications available in the XIENCE Sierra™ Stent that enhance crossability, pushability, post-dilation expansion, and treatment of long lesions.*

Improved XIENCE MULTI-LINK Design

The flexible, conformable MULTI-LINK design has been modified to allow for an even lower profile and for easier crossing of lesions.

 

XIENCE Sierra™ easily crosses calcified lesions
Single-Piece Outer Member

XIENCE Sierra™ offers improved deliverability with its enhanced stent delivery system that features a single-piece outer member for added pushability and trackability.*

XIENCE Sierra™ has seamless outer member

XIENCE Alpine™
Two-piece outer member

XIENCE Sierra™ has seamless outer member

XIENCE Sierra™
Seamless outer member is uniquely engineered to deliver consistent force

Greater Post-Dilation Capability

The latest stent design allows for post-dilatation up to 5.5 mm, to treat larger vessels.*

XIENCE Sierra™ dilates up to 5.5 mm
Small, Long Sizes

There are 4 sizes of the XIENCE Sierra™ stent that are useful when treating long, tapered lesions.

 

Stent
Diameter		   Stent
Length
2.0 mm x 33 mm
2.0 mm x 38 mm
2.25 mm x 33 mm
2.25 mm x 38 mm

See ordering information and all of the sizes available.

  • REFERENCES

    § 13,000,000 implants number is based on data of DES implants through Q4 2018. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe, and Korea. Other leading DES: BSX stents (Promus Element‡, Promus Element Plus‡, Promus Premier‡, SYNERGY‡); MDT stents (Resolute‡, Resolute Integrity‡, Resolute Onyx‡); Terumo stents (Nobori‡, Ultimaster‡); Biotronik stent (Orsiro‡); and Biosensors stent (BioMatrix‡). Data on file at Abbott.

    * Tests performed by and data on file at Abbott:

    • Enhanced design statement is in comparison to XIENCE Alpine™ Stent.
    • Catheter performance crossability refers to testing performed on XIENCE Sierra™ Stent (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5. Catheter performance crossability test measures average force to cross a challenging lesion model. 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.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent Systems.
    • Expanded treatment options with post-dilation expansion up to 5.5 mm (3.5-4.0 mm) and more complete size matrix for long tapered lesions. Side branch accessibility with workhorse diameter (3.0 x 18 mm) to treat bifurcations. Enhanced radial strength in workhorse sizes for highly calcified lesions (compared to previous generations).
    • Ultra-low stent crimped profile of 0.0390" refers to XIENCE Sierra™ Stent profile size of (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5.
    • Shortening statement refers to testing performed on a 4.0 mm diameter stent deployed to 5.5 mm. XIENCE Sierra™ Stent (4.0 x 18 mm) n=5, Synergy‡ Stent (4.0 x 20 mm) n=5, Resolute Onyx‡ Stent (4.5 x 18 mm) n=5, Orsiro‡ Stent (4.0 x 18 mm) n=5.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent System.
    • Retention testing is measured by dislodgement (lbf) average.

    1. Serruys, PW et al. RESOLUTE All Comers Trial, 1-Yr Results Presentation, EuroPCR 2010.
    2. Fajadet, PLATINUM PLUS, TCT 2012.
    3. Smits P, et al. Abluminal biodegradable polymer BES vs. durable polymer EES (COMPARE II): a randomised, controlled, non-inferiority trial, The Lancet, dx.doi.org/10.1016/S0140-6736(12)61852-2, Jan 2013.
    4. Saito, S et. al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial, European Heart Journal, May 2014.
    5. Pilgrim, T; Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE); Lancet. 2014.
    6. Natsuaki, M ; Two-year Outcome NEXT; ACC 2014.
    7. Pilgrim, T; Device and Clinical Program Highlights: Orsiro; TCT 2015.
    8. Windecker S, RESOLUTE All-Comers 5-Year Presentation, EuroPCR 2014.
    9. Smits; The Final 5 Year Results From The COMPARE II trial; PCR 2016.

With The Safety You’ve Always Relied On And The Deliverability You’ve Always Wanted

Crimped profile of 0.0390"With its latest stent design and thinner balloon technology, XIENCE Sierra™ Stent offers unmatched deliverability. Its ultra-low stent crimped profile of 0.0390" is able to cross very tight lesions in the target vessel.*


Stent design produces low profile

The low crimped stent profile can be particularly helpful in challenging anatomy.

Requiring Less Force to Cross Lesion

Crossing complex lesions can be easier if it is not necessary to apply great force. This is why XIENCE Sierra™ Stent has been designed to require less force in crossing lesions.*

 

Less force to cross lesions with XIENCE Sierra™
Ultra Low Stent Profile for Crossing Tight Lesions

XIENCE Sierra™ Stent offers an ultra low crimped stent profile of just 0.0390 inches when crossing tight lesions—a lower profile compared to other stents.* This feature is a result of the new stent design and balloon technology.

 

Lower stent profile to cross tight lesions
  • REFERENCES

    § 13,000,000 implants number is based on data of DES implants through Q4 2018. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe, and Korea. Other leading DES: BSX stents (Promus Element‡, Promus Element Plus‡, Promus Premier‡, SYNERGY‡); MDT stents (Resolute‡, Resolute Integrity‡, Resolute Onyx‡); Terumo stents (Nobori‡, Ultimaster‡); Biotronik stent (Orsiro‡); and Biosensors stent (BioMatrix‡). Data on file at Abbott.

    * Tests performed by and data on file at Abbott:

    • Enhanced design statement is in comparison to XIENCE Alpine™ Stent.
    • Catheter performance crossability refers to testing performed on XIENCE Sierra™ Stent (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5. Catheter performance crossability test measures average force to cross a challenging lesion model. 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.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent Systems.
    • Expanded treatment options with post-dilation expansion up to 5.5 mm (3.5-4.0 mm) and more complete size matrix for long tapered lesions. Side branch accessibility with workhorse diameter (3.0 x 18 mm) to treat bifurcations. Enhanced radial strength in workhorse sizes for highly calcified lesions (compared to previous generations).
    • Ultra-low stent crimped profile of 0.0390" refers to XIENCE Sierra™ Stent profile size of (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5.
    • Shortening statement refers to testing performed on a 4.0 mm diameter stent deployed to 5.5 mm. XIENCE Sierra™ Stent (4.0 x 18 mm) n=5, Synergy‡ Stent (4.0 x 20 mm) n=5, Resolute Onyx‡ Stent (4.5 x 18 mm) n=5, Orsiro‡ Stent (4.0 x 18 mm) n=5.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent System.
    • Retention testing is measured by dislodgement (lbf) average.

    1. Serruys, PW et al. RESOLUTE All Comers Trial, 1-Yr Results Presentation, EuroPCR 2010.
    2. Fajadet, PLATINUM PLUS, TCT 2012.
    3. Smits P, et al. Abluminal biodegradable polymer BES vs. durable polymer EES (COMPARE II): a randomised, controlled, non-inferiority trial, The Lancet, dx.doi.org/10.1016/S0140-6736(12)61852-2, Jan 2013.
    4. Saito, S et. al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial, European Heart Journal, May 2014.
    5. Pilgrim, T; Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE); Lancet. 2014.
    6. Natsuaki, M ; Two-year Outcome NEXT; ACC 2014.
    7. Pilgrim, T; Device and Clinical Program Highlights: Orsiro; TCT 2015.
    8. Windecker S, RESOLUTE All-Comers 5-Year Presentation, EuroPCR 2014.
    9. Smits; The Final 5 Year Results From The COMPARE II trial; PCR 2016.

XIENCE: The Gold Standard For Safety

Consistently Low Rates of Stent Thrombosis

As the world's leading DES*, XIENCE Sierra™ Stent is the gold standard for safety in stent implantation. Randomized multicenter clinical trials reveal the efficacy and safety of using XIENCE™ Stents even in complex percutaneous coronary interventions (PCI). The safety data are particularly compelling for rates of stent thrombosis (ST), with long-term clinical study data up to 5 years.10-15

 

Left Main10
Definite Stent Thrombosis at 4 Years - 1.1%

 

CTO11
Def/Prob Stent Thrombosis at 1 Year - 0.7%

 

Bifurcations12
Def/Prob Stent Thrombosis at 3 Years - 0.5%

 

Diabetes13
ARC Def/Prob Stent Thrombosis at 2 Years - 0.4%

 

STEMI14
Def/Prob Stent Thrombosis at 5 Years - 2.0%

 

Short DAPT15
Def/Prob Stent Thrombosis at 1 Year - 0.3%

DAPT duration of 1 month

Safety When Crossing Challenging Anatomy

Even when encountering difficult anatomy in certain cases, there is improved stent retention with XIENCE Sierra™ Stent compared with other stents as shown.*

Higher forces required to dislodge XIENCE Sierra™
  • References

    § 13,000,000 implants number is based on data of DES implants through Q4 2018. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe, and Korea. Other leading DES: BSX stents (Promus Element‡, Promus Element Plus‡, Promus Premier‡, SYNERGY‡); MDT stents (Resolute‡, Resolute Integrity‡, Resolute Onyx‡); Terumo stents (Nobori‡, Ultimaster‡); Biotronik stent (Orsiro‡); and Biosensors stent (BioMatrix‡). Data on file at Abbott.

    * Tests performed by and data on file at Abbott:

    • Enhanced design statement is in comparison to XIENCE Alpine™ Stent.
    • Catheter performance crossability refers to testing performed on XIENCE Sierra™ Stent (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5. Catheter performance crossability test measures average force to cross a challenging lesion model. 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.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent Systems.
    • Expanded treatment options with post-dilation expansion up to 5.5 mm (3.5-4.0 mm) and more complete size matrix for long tapered lesions. Side branch accessibility with workhorse diameter (3.0 x 18 mm) to treat bifurcations. Enhanced radial strength in workhorse sizes for highly calcified lesions (compared to previous generations).
    • Ultra-low stent crimped profile of 0.0390" refers to XIENCE Sierra™ Stent profile size of (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5.
    • Shortening statement refers to testing performed on a 4.0 mm diameter stent deployed to 5.5 mm. XIENCE Sierra™ Stent (4.0 x 18 mm) n=5, Synergy‡ Stent (4.0 x 20 mm) n=5, Resolute Onyx‡ Stent (4.5 x 18 mm) n=5, Orsiro‡ Stent (4.0 x 18 mm) n=5.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent System.
    • Retention testing is measured by dislodgement (lbf) average.

    1. Serruys, PW et al. RESOLUTE All Comers Trial, 1-Yr Results Presentation, EuroPCR 2010.
    2. Fajadet, PLATINUM PLUS, TCT 2012.
    3. Smits P, et al. Abluminal biodegradable polymer BES vs. durable polymer EES (COMPARE II): a randomised, controlled, non-inferiority trial, The Lancet, dx.doi.org/10.1016/S0140-6736(12)61852-2, Jan 2013.
    4. Saito, S et. al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial, European Heart Journal, May 2014.
    5. Pilgrim, T; Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE); Lancet. 2014.
    6. Natsuaki, M ; Two-year Outcome NEXT; ACC 2014.
    7. Pilgrim, T; Device and Clinical Program Highlights: Orsiro; TCT 2015.
    8. Windecker S, RESOLUTE All-Comers 5-Year Presentation, EuroPCR 2014.
    9. Smits; The Final 5 Year Results From The COMPARE II trial; PCR 2016.
    10. Stone, G. EXCEL: a prospective, randomized trial comparing everolimus-eluting stents and bypass graft surgery in selected patients with left main coronary artery disease. TCT 2018.
    11. Teeuwen, K. et al. Randomized multicenter trial investigating angiographic outcomes of hybrid sirolimus-eluting stents with biodegradable polymer compared with everolimus-eluting stents with durable polymer in chronic total occlusions (PRISON IV). JACC Cardiovasc Interv. 2017;10(2):133-143. doi:10.1016/j.jcin.2016.10.017.
    12. Lam, M. Three year clinical outcome of patients with bifurcation treatment with second-generation Resolute and XIENCE V stents in the randomized TWENTE Trial. Am Heart J. 2015;169.
    13. Kaul U, et al. 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.
    14. Sabaté M, et al. EXAMINATION Trial. Lancet. 2016;387;357-366.
    15. Watanable, H. et al. Effect of 1-month dual antiplatelet therapy followed by clopidogrel vs 12-month dual antiplatelet therapy on cardiovascular and bleeding events in patients receiving PCI: STOPDAPT2 Trial.  JAMA. 2019;321(24):2414-2427. doi:10.1001/jama.2019.8145.

Treating Large Or Small Vessels

Expanded Treatment

XIENCE Sierra™ Stent, with its ability to treat larger vessels, has expansion capability as follows*:

  • 3.75 mm post-dilatation for the smaller stent sizes 2.0 mm, 2.25 mm, 2.5 mm, 2.75 mm, 3.0 mm, and 3.25 mm
  • 5.5 mm post-dilatation for the larger stent sizes 3.5 and 4.0 mm

 

XIENCE Sierra™: 5.5 mm max expansion

With this variability in expansion sizes, interventional cardiologists can use XIENCE Sierra™ Stent to treat tapered vessels of various diameters.

Zero Shortening for Precise Placement

The XIENCE Sierra™ Stent exhibits 0% shortening even at maximum expansion, which further expands treatment options.*

  • Achieve unsurpassed precision in placement
  • Avoid geographic “misses” that can occur with stent shortening


 

XIENCE Sierra™: 0% shortening at 5.5 mm expansion
  • REFERENCES

    § 13,000,000 implants number is based on data of DES implants through Q4 2018. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe, and Korea. Other leading DES: BSX stents (Promus Element‡, Promus Element Plus‡, Promus Premier‡, SYNERGY‡); MDT stents (Resolute‡, Resolute Integrity‡, Resolute Onyx‡); Terumo stents (Nobori‡, Ultimaster‡); Biotronik stent (Orsiro‡); and Biosensors stent (BioMatrix‡). Data on file at Abbott.

    * Tests performed by and data on file at Abbott:

    • Enhanced design statement is in comparison to XIENCE Alpine™ Stent.
    • Catheter performance crossability refers to testing performed on XIENCE Sierra™ Stent (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5. Catheter performance crossability test measures average force to cross a challenging lesion model. 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.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent Systems.
    • Expanded treatment options with post-dilation expansion up to 5.5 mm (3.5-4.0 mm) and more complete size matrix for long tapered lesions. Side branch accessibility with workhorse diameter (3.0 x 18 mm) to treat bifurcations. Enhanced radial strength in workhorse sizes for highly calcified lesions (compared to previous generations).
    • Ultra-low stent crimped profile of 0.0390" refers to XIENCE Sierra™ Stent profile size of (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5.
    • Shortening statement refers to testing performed on a 4.0 mm diameter stent deployed to 5.5 mm. XIENCE Sierra™ Stent (4.0 x 18 mm) n=5, Synergy‡ Stent (4.0 x 20 mm) n=5, Resolute Onyx‡ Stent (4.5 x 18 mm) n=5, Orsiro‡ Stent (4.0 x 18 mm) n=5.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent System.
    • Retention testing is measured by dislodgement (lbf) average.

    1. Serruys, PW et al. RESOLUTE All Comers Trial, 1-Yr Results Presentation, EuroPCR 2010.
    2. Fajadet, PLATINUM PLUS, TCT 2012.
    3. Smits P, et al. Abluminal biodegradable polymer BES vs. durable polymer EES (COMPARE II): a randomised, controlled, non-inferiority trial, The Lancet, dx.doi.org/10.1016/S0140-6736(12)61852-2, Jan 2013.
    4. Saito, S et. al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial, European Heart Journal, May 2014.
    5. Pilgrim, T; Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE); Lancet. 2014.
    6. Natsuaki, M ; Two-year Outcome NEXT; ACC 2014.
    7. Pilgrim, T; Device and Clinical Program Highlights: Orsiro; TCT 2015.
    8. Windecker S, RESOLUTE All-Comers 5-Year Presentation, EuroPCR 2014.
    9. Smits; The Final 5 Year Results From The COMPARE II trial; PCR 2016.

Ordering Information For XIENCE Sierra™ Stents

Stent Diameter Length Post-Dilatation Limit
8 mm 12 mm 15 mm 18 mm
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 Length Post-Dilatation Limit
23 mm 28 mm 33 mm 38 mm
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

 

  • REFERENCES

    § 13,000,000 implants number is based on data of DES implants through Q4 2018. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe, and Korea. Other leading DES: BSX stents (Promus Element‡, Promus Element Plus‡, Promus Premier‡, SYNERGY‡); MDT stents (Resolute‡, Resolute Integrity‡, Resolute Onyx‡); Terumo stents (Nobori‡, Ultimaster‡); Biotronik stent (Orsiro‡); and Biosensors stent (BioMatrix‡). Data on file at Abbott.

    * Tests performed by and data on file at Abbott:

    • Enhanced design statement is in comparison to XIENCE Alpine™ Stent.
    • Catheter performance crossability refers to testing performed on XIENCE Sierra™ Stent (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5. Catheter performance crossability test measures average force to cross a challenging lesion model. 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.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent Systems.
    • Expanded treatment options with post-dilation expansion up to 5.5 mm (3.5-4.0 mm) and more complete size matrix for long tapered lesions. Side branch accessibility with workhorse diameter (3.0 x 18 mm) to treat bifurcations. Enhanced radial strength in workhorse sizes for highly calcified lesions (compared to previous generations).
    • Ultra-low stent crimped profile of 0.0390" refers to XIENCE Sierra™ Stent profile size of (3.0 x 18 mm) n = 5, SYNERGY‡ Stent(3.0 x 20 mm) n = 5, Resolute Onyx‡ Stent (3.0 x 18 mm) n = 5.
    • Shortening statement refers to testing performed on a 4.0 mm diameter stent deployed to 5.5 mm. XIENCE Sierra™ Stent (4.0 x 18 mm) n=5, Synergy‡ Stent (4.0 x 20 mm) n=5, Resolute Onyx‡ Stent (4.5 x 18 mm) n=5, Orsiro‡ Stent (4.0 x 18 mm) n=5.
    • Increased maximum expansion compared to other XIENCE™ Everolimus Eluting Coronary Stent System.
    • Retention testing is measured by dislodgement (lbf) average.

    1. Serruys, PW et al. RESOLUTE All Comers Trial, 1-Yr Results Presentation, EuroPCR 2010.
    2. Fajadet, PLATINUM PLUS, TCT 2012.
    3. Smits P, et al. Abluminal biodegradable polymer BES vs. durable polymer EES (COMPARE II): a randomised, controlled, non-inferiority trial, The Lancet, dx.doi.org/10.1016/S0140-6736(12)61852-2, Jan 2013.
    4. Saito, S et. al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial, European Heart Journal, May 2014.
    5. Pilgrim, T; Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE); Lancet. 2014.
    6. Natsuaki, M ; Two-year Outcome NEXT; ACC 2014.
    7. Pilgrim, T; Device and Clinical Program Highlights: Orsiro; TCT 2015.
    8. Windecker S, RESOLUTE All-Comers 5-Year Presentation, EuroPCR 2014.
    9. Smits; The Final 5 Year Results From The COMPARE II trial; PCR 2016.

 

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