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Abbott
Cardiovascular

Elevando os padrões de cuidado na embolização periférica

  • Solução com um único dispositivo que possibilita procedimentos mais rápidos, menor exposição à radiação e menores custos de procedimento.1,2

  • Rápida embolização, mesmo em vasos de alto fluxo.1,3,5

  • Projetado para um posicionamento preciso, entrega controlada e recaptura completa.

  • Uma família de plugs para diferentes anatomias vasculares.

  • Artefato de imagem limitado.4

Conhece este estudo clínico sobre Plugs Vasculares Amplatzer™?
O estudo clínico  "Embolization of the Internal Iliac Artery: Cost-Effectiveness of Two Different Techniques" faz uma análise dos Plugs Vasculares Amplatzer™ (AVP) da Abbott.

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Amplatzer™ Plug Vascular (AVP)

  • Lóbulo único, com apenas uma camada de nitinol7
  • Marcadores de platina nas duas extremidades7
  • Selecione um dispositivo com diâmetro ~30-50% maior do que o diâmetro do vaso alvo7

Amplatzer™ Plug Vascular II (AVP II)

  • Malha em múltiplas camadas de nitinol, projetada para aumentar a densidade e o “distúrbio” ao fluxo sanguíneo8
  • Seis planos de cobertura da seção transversal8, resultando em uma rápida oclusão1
  • Selecione um dispositivo com diâmetro ~30-50% maior do que o diâmetro do vaso alvo8

Amplatzer™ Plug Vascular 4 (AVP 4)

  • Entrega simples através de um fio 0.038”, compatível com catéter diagnóstico9
  • Boa navegabilidade através de anatomias tortuosas6
  • Alcance estendido para vasos distais6
  • Selecione um dispositivo com diâmetro ~30-50% maior do que o diâmetro do vaso alvo9


Mecanismo de Ação dos Plugs Vasculares Amplatzer™ (AVP)

A malha de nitinol de um AVP atua como um agente embólico que promove rápida formação de coágulos. Cada AVP cria uma barreira física à passagem do fluxo sanguíneo, estimulando a resposta imunológica, seguida da ativação do processo natural de coagulação.6


Finalidade

O Amplatzer™ Vascular Plug, Amplatzer™ Vascular Plug II e Amplatzer™ Vascular Plug 4 são destinados à embolização terapêutica, para redução ou obstrução do fluxo sanguíneo.


Indicação de Uso

O Amplatzer™ Vascular Plug, Amplatzer™ Vascular Plug II e Amplatzer™ Vascular Plug 4 são indicados para embolização arterial e venosa em vasos periféricos.

 

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

Referências

  1. Pech M, Kraetsch A, Wieners G, et al. Embolization of the Gastroduodenal Artery Before Selective Internal Radiotherapy: A prospectively Randomized Trial Comparing Platinum-Fibered Microcoils with the AMPLATZER Vascular Plug II. CVIR 2009(32)3:455-61.
  2. Hart JL, Aldin Z, et al. Embolization of pulmonary arteriovenous malformations using the AMPLATZER vascular plug: successful treatment of 69 consecutive patients. Eur Radiol. 2010;20(11)2663-70.
  3. Kucukay F, Özdemir M, Şenol E, Okten S, Ereren M, Karan A. Large pulmonary arteriovenous malformations: long-term results of embolization with AMPLATZER vascular plugs. J Vasc Interv Radiol. 2014 Sep;25(9):1327-32. doi: 10.1016/j.jvir.2014.01.031. Epub 2014 Mar 18.
  4. Vandy F, Criado E, Upchurch GR, et al. Translumihnal Hypogastric Artery Occlusion with an Amplatzer Vascular Plug During Endovascular Aortic Aneurysm Repair. J Vasc Surg. 2008; 48(5)1121-4.
  5. Data on file at Abbott.
  6. Lopera, Jorge E. “The Amplatzer vascular plug: review of evolution and current applications.” Seminars in interventional radiology. Vol. 32. No. 04. Thieme Medical Publishers, 2015.
  7. Amplatzer™ Vascular Plug – Instruções de Uso. Consulte o manual de Instruções de Uso para informações adicionais.
  8. Amplatzer™ Vascular Plug II – Instruções de Uso. Consulte o manual de Instruções de Uso para informações adicionais.
  9. Amplatzer™ Vascular Plug 4 – Instruções de Uso. Consulte o manual de Instruções de Uso para informações adicionais.

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