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Paravalvular Leak (PVL)

Valvular plug hcp header

Delivering an effective solution for a wide range of PVL morphologies1,5,6

Introducing the Amplatzer Valvular Plug III

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 up to 93% of patients at 12 month follow-up. 3

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 for an increasing number of patients. 3

Clinically proven outcomes

93%
Up to 93% of PVL reduced to moderate or less.3,8
90%
Up to 90% of patients report one-class NYHA classification improvement3

Clinical studies continue to show that the Amplatzer Valvular Plug III, formerly known as AVP III, is a highly effective solution in closing PVLs near mechanical surgical valves.1,3,5

Valvular plug device

Built on the extensive Amplatzer™ Legacy of safety and efficacy

  • Pioneered transcatheter cardiovascular and peripheral vascular occlusion
  • Over 1.25 million Amplatzer devices implanted worldwide10
  • More than 20 years of clinical experience and global leadership

Every detail is designed for successful PVL closure

  • Additional layers of dense nitinol wire facilitate rapid occlusion
  • In this shape, the disc can fit a large range range of paravalvular leak morphologies.
  • Designed to minimize valve leaflet interference
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, Jasiński M, et al. Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: A prospective registry. Catheter Cardiovasc Interv. 2016;87(3):478-487.
  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. 014;148(5):1965-1969.
  7. 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.
  8. 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.
  9. Nietlispach F, Eckstein F, Seeberger M, Osswald S, Kaufmann BA, Reuthebuch O. Closure of apical access site after transapical, transcatheter paravalvular leak closure. Can J Cardiol. 2012;28:516.e5-7.
  10. Data on File at Abbott
MAT-2013069 v1.0 | Item approved for Global OUS use only.

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