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Cardiovascular

Stent Periférico Supera™

El Stent Periférico Supera™ es una clase única de tecnología AFS. Diseñado con una innovadora tecnología de alambre entrelazado, este stent de nitinol ofrece a los médicos resultados clínicos inigualables1-12 en diversas complejidades de lesiones y longitudes.1, 13-15


Los resultados importan

El Stent Supera™ es conocido por la excelencia de sus resultados clínicos después de los procedimientos de angioplastia transluminal percutánea (ATP) con colocación de stent, ya que este stent periférico se ha estudiado en más de 2.000 pacientes y 17 estudios en todo el mundo.1,15-30
 


91% patency at 1 year

PERMEABILIDAD (K-M) A 1 AÑO

Cuando se despliega nominalmente*


94% freedom from TLR at 3 years

LIBERTAD DE TLR A LOS 3 AÑOS

Cuando se despliega nominalmente*

*El despliegue nominal se define como la longitud del stent en el momento del despliegue que se encuentra dentro de +/- 10% de la longitud del stent. Estos datos provienen de un análisis post-hoc no potenciado.

 

Demuestra excelentes resultados clínicos

El Stent Supera™ demostró una excelente permeabilidad de 1 año y 3 años de ausencia de TLR en la prueba SUPERB.1
 

1

Resultados clínicos notables

Resultados clínicos inigualables demostrados en lesiones simples1-12

2

Permeabilidad constante independientemente de la longitud de la lesión*

Exhibe resultados consistentes de permeabilidad primaria a 1 año, independientemente de la longitud de la lesión13-20,31

3

Resultados sólidos en la calcificación

Revela resultados clínicos sólidos en lesiones severamente calcificadas a 1 año y 3 años1

El estudio reportó un 93,8% de lesiones A y B del Trans-Atlantic Inter-Society Consensus Document (TASC) y/o lesiones de clase 2 o 3 de Rutherford

*Las tasas de permeabilidad se han evaluado en estudios con longitudes de lesión que oscilan entre 5,3 cm y 28,0 cm.


La plataforma importa

A diferencia de cualquier otra plataforma de diseño de stent, el Stent Supera™ está diseñado de manera única para mantener los vasos abiertos con su plataforma distintiva, creada por alambres de nitinol individuales y flexibles entrelazados.

High compression resistance

Alta resistencia a la compresión32

4 veces más fuerza para la resistencia a la compresión, por lo que puede mantener un lumen redondo y abierto, lo que puede ser especialmente beneficioso en lesiones calcificadas


Low outward force

Baja fuerza crónica hacia afuera32

Con un tamaño 1:1 del stent al vaso, la baja fuerza crónica hacia afuera da como resultado una lesión mínima del vaso34


High flexibility

Alta Flexibilidad33 y Resistencia a Fracturas1

Flexibilidad sin precedentes,33 que imita la estructura natural y el movimiento de la anatomía35-37

Cero fracturas de stent reportadas a 1 año en más de 2,000 pacientes en 17 estudios1,15-30

 

The XIENCE™ Stent is also recognized as being significantly more anti-thrombotic than other DES on the market. As shown in the study findings, XIENCE™ Stent reveals significantly less (p < 0.01) platelet adhesion—shown in red in the confocal microscopy images—than other DES, and platelet adhesion is an important factor in stent thrombosis.*8 These findings suggest that this stent choice “may be ideally suited for very short-term DAPT.”8

*Ex Vivo Swine Shunt Model.

XIENCE™ Stent is thromboresistant, showing significantly less (p < 0.01) platelet adhesion than Synergy,‡ Orsiro,‡ Ultimaster,‡ Onyx,‡ and BioFreedom‡ DES.

Diamondback 360™ OAS Gives You the Versatility to Treat Challenging Cases

Treat even the most severely calcified lesions, with under 2-minute setup7,8 and predictable procedure times.2

Facilitates antegrade and retrograde treatment of:

  • Long, Diffuse Lesions
    Successfully treated lesions up to 60 mm in length in real-world study.9
  • Heavily Stenosed Lesions
    Crossed >99% of lesions with <2% pre-dilatation in the ORBIT II study.1,10
  • Nodular Lesions
    Effectively treats nodular calcification.5,6
  • Ostial Lesions
    Safely treats ostial lesions.11-13

Low Profile
6F compatible for femoral or radial access.14
 

Multiple Vessel Sizes
A single 1.25 mm crown treats vessels 2.5 mm to 4.0mm14

Diamondback 360™ OAS Has Been Proven Effective and Safe in the Treatment of Severely Calcified Lesions.
Extensively studied, and with over 100,000 patients treated,15 orbital atherectomy has been demonstrated to perform effectively and safely in the treatment of severely calcified lesions.

 
Proven Safety

 
Procedural Success

 
Low Q-Wave MI Rate

 

>2,200

<1%

97.7%

0.9%

Patients Across 11
Robust Studies5,9

 

Component Angiographic
Complications in Two
Real-world Studies9,16

Crossing and Stent
Deployment in ORBIT II Study1

 

In the ORBIT II 
Study at 30 days1

 


Sustained Clinical Performance

Data are for ORBIT II TLR in the OA+DES patient cohort.

“Stopping DAPT at 3 months in selected patients after [XIENCE™ Stent] implantation was at least as safe as the prolonged DAPT regimen adopted in the historical control group.”

— Masahiro Natsuaki, MD, STOPDAPT Trial9

STOPDAPT 2 Trial Design and Randomization10

Exclusion criteria in STOPDAPT 2 included patients on oral anticoagulants, with a history of intracranial bleeding, and with major in-hospital complications such as MI, stroke or major bleeding

Short 1-Month DAPT

  • 0 to 1-month: Aspirin + P2Y12
  • After 1-month: Clopidogrel monotherapy
Exclusion criteria in STOPDAPT 2 included patients on oral anticoagulants, with a history of intracranial bleeding, and with major in-hospital complications such as MI, stroke or major bleeding

12-Month DAPT

  • 0 to 1-month: Aspirin + P2Y12
  • 1 to 12-month: Aspirin + Clopidogrel
  • 12 to 60-month: Aspirin monotherapy
Key inclusion criteria
  1. Successful PCI using CoCr everolimus-eluting stent: XIENCE™
  2. Eligible for DAPT (aspirin/P2Y12 receptor blocker) for 1 year
Key exclusion criteria
  1. Patients who need oral anticoagulants
  2. History of intracranial bleeding
  3. Major in-hospital complications (MI/stroke/major bleeding)

STOPDAPT Study: XIENCE™ Stent with 3-Month DAPT Is Feasible9

STOPDAPT9 was the first prospective trial to study DAPT cessation at 3 months after implantation. Among other 1-year outcomes, the XIENCE™ Stent rate of stent thrombosis was 0.0%.

STOPDAPT Study Demonstrates Feasibility of XIENCE™ Stent with 3-Month DAPT9

XIENCE™ Stent 1-year data, when using 3-month DAPT, shows 0.0% definite or probable stent thrombosis

Learn more about STOPDAPT 2

“It was noteworthy that no definite or probable stent thrombosis occurred in [XIENCE™ Stent] patients enrolled in STOPDAPT.”

— Masahiro Natsuaki, MD, STOPDAPT Trial9

STOPDAPT-3 Trial Design and Randomization11

Key inclusion criteria
  1. PCI with planned exclusive use of CoCr-EES (XIENCE)
  2. ACS presentation or ARC-HBR
  3. Eligible for DAPT (Aspirin/P2Y12inhibitor) for 1 month

Study design and Randomization

Group 1:

0 to 1-month: Aspirin + P2Y12 (Prasugrel)

After 1-month: Clopidogrel monotherapy

Group 2:

0 to 1-month: P2Y12 (Prasugrel)

After 1-month: Clopidogrel monotherapy

STOPDAPT-3 Trial 11 was designed to explore 0-month DAPT* (SAPT˄ using only P2Y12 inhibitor) for ACS and HBR patients.

Though the results are comparable for both bleeding and ischemic events for DAPT and SAPT arms, the study did not meet its endpoint and concluded to use DAPT for 1 month after PCI.

Major bleeding
CV Death, MI, Definte ST, Ischemic Stroke
XIENCE Stent Efficacy

XIENCE™ Stent remains the ONLY DES with the shortest DAPT indication, as short as 28 days.12

Referencias

  1. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267.
  2. Dake M. et al., Circulation. 2016;133:1472-1483.
  3. Laird J. et al., Circ Cardiovasc Interv. 2010;3:267-276.
  4. Laird J et al., J Endovasc Ther. 2012;19:1–9.
  5. S.M.A.R.T. Control IFU.
  6. Jaff, M., SMART Nitinol Self-Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease:  Three-year Clinical Outcomes from the STROLL Trial. ISET 2014.
  7. Matsumura J et al., J Vasc Surg 2013;58:73-83.
  8. Rocha-Singh, K., 3-Year Results of the DURABILITY II Study. VIVA 2013.
  9. US Innova IFU.
  10. US Pulsar IFU.
  11. Ohki T. et al. J Vasc Surg. 2016 Feb;63(2):370-6.
  12. Gray W. et al., Lancet 2018;392:1541-51.
  13. Treitl, K.M., et al. European Radiology. 2017; 10.1007.
  14. Palena L.M. et al. Catheterization and Cardiovascular Intervention. 2016.
  15. Brescia AA. et al., J Vasc Surg. 2015 Jun;61(6):1472-8
  16. George JC. et al., J Vasc Interv Radiol. 2014 Jun;25(6):954-61.
  17. Montero-Baker M. et al., J Vasc Surg. 2016 Oct;64(4):1002-8.
  18. Scheinert D. et al., J Endovasc Ther. 2011 Dec;18(6):745-52.
  19. Werner M. et al., EuroIntervention. 2014 Nov;10(7):861-8.
  20. San Norberto EM. et al., Ann Vasc Surg. 2017 May;41:186-195.
  21. Chan YC. et al., J Vasc Surg. 2015 Nov;62(5):1201-9.
  22. Dumantepe M. Vasc Endovascular Surg. 2017 Jul;51(5):240-246.
  23. Goltz JP. et al., J Endovasc Ther. 2012 Jun;19(3):450-6.
  24. León LR Jr. et al., J Vasc Surg. 2013 Apr;57(4):1014-22.
  25. Myint M. et al., J Endovasc Ther. 2016 Jun;23(3):433-41.
  26. Palena LM. et al., J Endovasc Ther. 2018 Oct;25(5):588-591.
  27. Scheinert D. et al., JACC Cardiovasc Interv. 2013 Jan;6(1):65-71.
  28. Steiner S. et al., J Endovasc Ther. 2016 Apr;23(2):347-55.
  29. Teymen B. et al., Vascular. 2018 Feb;26(1):54-61.
  30. Bhatt H. et al., Cardiovasc Revasc Med. 2018 Jul;19(5 Pt A):512-515.
  31. Garcia L. et al. Circ Cardiovasc Interv. 2015;8:e000937
  32. Competitors tested include Astron Pulsar-18, Complete SE, EverFlex, Innova, LifeStent, Misago, S.M.A.R.T., and Zilver PTX. Data on file at Abbott.
  33. Flexibility is defined as kink resistance. Competitors tested include Astron Pulsar-18, Complete SE, EverFlex, Innova, LifeStent, Misago, S.M.A.R.T., and Zilver PTX. Data on file at Abbott.
  34. Zhao HQ et al. Cardiovasc Intervent Radiol. 2009;32(4):720-6
  35. Arena F. et al., J Vasc Med Surg. 2013:1;116.
  36. Chen Y. et al., J Vasc Surg 2014;59:384-91.
  37. Data on file at Abbott.

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