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STRUCTURAL INTERVENTIONS

Amplatzer™ Valvular
Plug III

Paravalvular leaks (PVLs) are a common and challenging problem around the world.1 The Amplatzer™ Valvular Plug III is specially designed to provide an effective solution to this key issue, improving quality of life and longevity for an increasing number of patients.2-5

DELIVERING AN EFFECTIVE SOLUTION FOR A WIDE RANGE OF PVL MORPHOLOGIES2,6,7

Paravalvular leaks (PVL) can be found in a variety of shapes and sizes. To tackle the leaks and fill the gaps of different morphologies, the Amplatzer™ Valvular Plug III is designed in an asymmetrical oblong shape that fits a wide range of PVL. As such, the Amplatzer Valvular Plug III can provide effective closure in up to 93% of patients.1, 5, 6

A solution to a key issue

Around the world, PVL are a common and challenging problem, occurring in 7% to 17% of mitral valve replacements (MVR) and 5% to 10% of aortic valve replacements (AVR).1 Risk factors for PVL development include: annular calcification, tissue friability, prior endocarditis, or other inflammatory processes, and recent initiation of corticosteroid therapy.8 PVL can occur soon after valve replacement or several years later.2.6

By providing an effective solution to this key issue, the Amplatzer™ Valvular Plug III is improving quality of life for an increasing number of patients.2-5

Watch the Amplatzer Valvular Plug III
implant procedure video.

Built on the extensive Amplatzer™ legacy of safety and efficacy

  • Pioneered transcatheter cardiovascular and peripheral vascular occlusion
  • Over 1.25 million Amplatzer devices implanted worldwide9
  • More than 20 years of clinical experience and global leadership

Every detail is designed for successful PVL closure

The Amplatzer Valvular Plug III has been specially designed to offer patients an effective solution to PVL. This oblong, self-expanding device is made from braided Nitinol wires with shape memory characteristics, making it well suited to PVL closure.2,6,7,9,10

To close PVL with different morphologies, the Amplatzer Valvular Plug III comes in a range of 9 sizes and has a flexible Nitinol waist, ensuring an excellent device-to-patient fit.

The Amplatzer Valvular Plug III is designed with an oblong shape to fit a large range of paravalvular leak morphologies
Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use


GET THE AMPLATZER PORTFOLIO APP

The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
 

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MAT-2201627 v4.0 | Item approved for OUS use only.

References
  1. Rama-Merchan J, Arribas-Jimenez A, et al. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. Rev Esp Cardiol. 2014;67:593-596. 
  2. Ruiz CE, Hahn RT, Berrebi A, et al. Clinical trial principles and endpoint definitions for paravalvular leaks in surgical prosthesis: an expert statement. J Am Coll Cardiol. 2017;69(16):2067-2087.
  3. Calvert PA, Northridge DB, Malik IS, et al. Percutaneous device closure of paravalvular leak: combined experience from the United Kingdom and Ireland. Circulation. 2016;134(13):934-944.
  4. García E, Arzamendi D, Jimenez-Quevedo P, et al. Outcomes and predictors of success and complications for paravalvular leak closure: an analysis of the SpanisH real-wOrld paravalvular LEaks closure (HOLE) registry. EuroIntervention. 2017;12(16):1962-1968.
  5. Davidavicius G, Rucinskas K, Drasutiene A, et al. Hybrid approach for transcatheter paravalvular leak closure of mitral prosthesis in high-risk patients through transapical access. J Thorac Cardiovasc Surg. 2014;148(5):1965-1969.
  6. Smolka G, Pysz P, Jasinski M, et al. Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: a prospective registry. Catheter Cardiovasc Interv. 2016;87(3):478-487.
  7. Yildirim A, Goktekin O, Gorgulu S, et al. A new specific device in transcatheter prosthetic paravalvular leak closure: a prospective two-center trial. Catheter Cardiovasc Interv. 2016;88(4):618-624.
  8. Angulo-Llanos R, Sarnago-Cebada F, Rivera AR, et al. Two-year follow up after surgical versus percutaneous paravalvular leak closure: a non-randomized analysis. Catheter Cardiovasc Intervent. 2016;88(4):626-634.
  9. Data on File at Abbott.
  10. Sánchez-Recalde A, Moreno R, Galeote G, et al. Immediate and midterm clinical course after percutaneous closure of paravalvular leakage. Rev Esp Cardiol (Engl Ed). 2014;67(8):615-623.
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