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Amplatzer™ Valvular Plug III

For closure of paravalvular leaks (PVL) adjacent to a surgically implanted heart valve

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Delivering one-class improvement in the NYHA classification in up to 90% of patients1,2,3,4 and an effective solution for a wide range of PVL morphologies1,5,6

Paravalvular leaks 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 a rectangular oval shape that fits a wide range of paravalvular leaks (PVL). As such, the Amplatzer Valvular Plug III can provide effective closure in over 90% of patients at 30 day follow up.6,7,8

A Solution To A Key Issue

Around the world, paravalvular leaks are a common and challenging problem: paravalvular leaks occur in 7% to 17% of mitral valve replacements (MVRs) and 5% to 10% of aortic valve replacements (AVRs).9 By providing an effective solution to this key issue, the Amplatzer Valvular Plug III is improving life quality and longevity to an increasing number of patients.1,2,3,4

 

Amplatzer™ Valvular Plug III

New Version Available

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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Learn more about Amplatzer™ Valvular Plugs by visiting the Abbott Structural Heart website.

View Amplatzer Valvular Plugs III Clinical Data
Abbott Structural Heart Website

Ordering Information
Amplatzer™ Valvular Plug III

Amplatzer Valvular Plug III ordering information
Model NumberType Amplatzer
Valvular Plug III		A
Waist Long
Axis (mm)		B
Waist Short
Axis (mm)		C
Overhang
(mm)		D
Plug Length
(+1.0 mm / -0.5 mm)
9-APVL3-0424x2 mm4226.5
9-APVL3-0636x3 mm6326.5
9-APVL3-0848x4 mm8426.5
9-APVL3-10310x3 mm10326.5
9-APVL3-10510x5 mm10526.5
9-APVL3-12312x3 mm12326.5
9-APVL3-12512x5 mm12526.5
9-APVL3-14314x3 mm14326.5
9-APVL3-14514x5 mm14526.5

 

References

  1. Calvert et al. Percutaneous device closure of paravalvular leak. Circulation. 2016;134(13):934-944.
  2. 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.
  3. Smolka G, Pysz P, Kozłowski M, et al. Transcatheter closure of paravalvular leaks using a paravalvular leak device - a prospective Polish registry. Postepy Kardiol Interwencyjnej. 2016;12(2):128-134.
  4. 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. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions. 2016;88(4):626-634.
  5. Garcia 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.
  6. 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.
  7. Smolka G, Pysz P, Jasiński M, et al. Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: A prospective registry. Catheter Cardiovasc Interv. 2016;87(3):478-487.
  8. Werner N, Zeymer U, Fraiture B, et al. Interventional treatment of paravalvular regurgitation by plug implantation following prosthetic valve replacement: a single-center experience. Clin Res Cardiol. 2018.
  9. Cruz-Gonzalez I, Rama-Merchan JC, Rodriguez-Collado J, et al. Transcatheter closure of paravalvular leaks: state of the art. Neth Heart J. 2017;25(2):116-124.

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