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Cardiovascular

Sistema de Aterectomía Orbital Coronaria Diamondback 360™1


El Diamondback 360™ es el único sistema de aterectomía con una corona revestida de diamante que orbita 360 grados, diseñado específicamente para abordar el calcio severo para la optimización de la entrega, expansión y aposición del stent.2-5

Diamondback 360 6 Fr Guide Compatible Compatible con Guía 6 Fr

Diamondback 360 Electric Powered Handle Cable Eléctrico

Diamondback 360 Single Touch Start Botón de Inicio con un toque facilita el inicio rápido y sin esfuerzo del dispositivo

Diamondback 360 Two Speed Dos controles de velocidad convenientes permiten ajustes rápidos dentro del campo estéril

Diamondback 360 Quick Flushing  Botón de presurización permite el lavado rápido dentro del campo estéril


Corona Única de 1,25 mm1


Corona excéntrica revestida de diamante con capacidades bidireccionales que trata una variedad de vasos, permitiendo el tratamiento de múltiples lesiones y tamaños de vasos con un solo dispositivo.

Componentes del sistema


Configuración del sistema en menos de 2 minutos6,7



Modo GlideAssist™

El GlideAssist™ permite que la corona gire a una velocidad lenta (5K RPM), reduciendo la fricción en el sistema para:8


  • Facilitar el seguimiento del dispositivo
  • Facilitar la extracción del dispositivo
  • Permitir un reposicionamiento más suave del ViperWire Advance™ durante los procedimientos


 

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. Diamondback 360™ Coronary Orbital Atherectomy System Instructions for Use (IFU). Refer to IFU for additional information.
  2. Chambers, J., et al., JACC Cardiovasc Interv. 2014;7(5):510-518.
  3. Shlofmitz, E., et al., Expert Rev Med Devices. 2017;14(11):867-879.
  4. Yamamoto, M., et al., Catheter Cardiovasc Interv. 2019;93(7):1211-1218.
  5. Kini, A., et al., Catheter Cardiovasc Interv. 2015;86(6):1024-1032.
  6. Lee, MS, et al., J Invasive Cardiol. 2016;28(4):147-150.
  7. Moses, J., Cardiac Interventions Today. 2015;May/June:75. Link accessed November 20, 2023. https://citoday.com/articles/2015-may-june/vessel-preparation-with-orbital-atherectomy-for-treating-severe-coronary-calcium-for-stent-delivery.
  8. Data on file at Abbott.

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