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
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Ordering Information
Amplatzer™ Valvular Plug III
| Model Number | Type 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-APVL3-042 | 4x2 mm | 4 | 2 | 2 | 6.5 |
| 9-APVL3-063 | 6x3 mm | 6 | 3 | 2 | 6.5 |
| 9-APVL3-084 | 8x4 mm | 8 | 4 | 2 | 6.5 |
| 9-APVL3-103 | 10x3 mm | 10 | 3 | 2 | 6.5 |
| 9-APVL3-105 | 10x5 mm | 10 | 5 | 2 | 6.5 |
| 9-APVL3-123 | 12x3 mm | 12 | 3 | 2 | 6.5 |
| 9-APVL3-125 | 12x5 mm | 12 | 5 | 2 | 6.5 |
| 9-APVL3-143 | 14x3 mm | 14 | 3 | 2 | 6.5 |
| 9-APVL3-145 | 14x5 mm | 14 | 5 | 2 | 6.5 |
References
- Calvert et al. Percutaneous device closure of paravalvular leak. Circulation. 2016;134(13):934-944.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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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