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Cardiovascular

Catéter de Imagen Dragonfly Opstar™: El nuevo diseño incrementa la confianza en su capacidad de entrega.


El Catéter de Imagen Dragonfly OpStar™ se utiliza para obtener imágenes intravasculares por medio de Tomografía de Coherencia Óptica (OCT). El Catéter de Imagen Dragonfly OpStar™ es compatible con OPTIS™ Next System (software Ultreon™ 1.0), OPTIS™ Mobile System (software AptiVue™ versión 5.1 o superior) e ILUMIEN™ System (software AptiVue™ versión D3 o superior) ¹.
El nuevo diseño del catéter incrementa la confianza en su capacidad de entrega segura y decisiones de tratamiento más precisas²
  • Navegar por la anatomía tortuosa y acceder a las lesiones distales.
  • Proporciona imágenes más brillantes y de mayor calidad. ²




Capacidad de entrega segura





CAPACIDAD DE CRUCE
MEJORADA

• Perfil de punta bajo
• Perfil de cruce 26% más bajo²
EMPUJE
MEJORADO

• Capaz de resistir un
47% mas de fuerza proximal
sin prolapsar.²
TRAZABILIDAD
MEJORADA

• Puerto reforzado
• Puerto de RX de la guía sin inclinación
• Capa interior lubricante para una
menor interacción con el alambre
guía²

 

Dragonfly OpStar™
Catéter de imagen



 

Decisiones de Tratamiento Precisas

NUEVO El rediseño de la lente proporciona imágenes 44% más brillantes, para ayudar a mejorar la identificación de la lamina elástica externa (EEL) y la morfología2


Construcción actualizada para mejorar la durabilidad, el brillo y la calidad de imagen.

Mayor enfoque
donde lo necesita.

*Datos archivados en Abbott. Afirmaciones comparativas versus la generación anterior del dispositivo, el catéter de imágenes Dragonfly™ OPTIS™

NOTA: Imágenes adquiridas con el software AptiVue Imaging


NOTA: Imágenes adquiridas con el software AptiVue Imaging²



Dragonfly OpStar™
Catéter de imagen




Dragonfly OPTIS™
Catéter de imagen





NUEVO La ubicación del marcador
proximal esta más lejos
del lente de imagen para poder
encuadrar un retroceso de 75 mm²
 

NUEVO Marcador de lente ahora inmediatamente
proximal a la lente de imagen para un co-registro más preciso.
Compárese con el lente del catéter de imágenes
Dragonfly™ OPTIS™, que es proximal al lente por 1-2 mm²




 

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 Studies
5,9

 

Component Angiographic
Complications in Two
Real-world Studies
9,16

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. Dragonfly OpStar™ Imaging Catheter Instructions for Use. Refer to IFU for additional information.
  2. Data on file at Abbott. Comparative claims versus the previous generation of the device, Dragonfly™ OPTIS™ Imaging Catheter.
  3. Dragonfly™ OPTIS™ Instructions for use (IFU). Refer to IFU for additional information.

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