Designed for life.

Clinical data

Older man hiking

The proof is in your patient

  • The PERIGON Pivotal Trial is the largest prospective trial for pericardial stented surgical valves with 38 centers globally with more than 1,100 patients enrolled.  
  • All study echocardiograms analyzed by an independent core laboratory.

Key study highlights1

  • Durability: 0 SVD through 5 years
  • Functionality: > 95% of patients had less than mild central regurgitation
  • Efficiency: Stable low mean gradients through 5 years
  • Safety: > 95% of patients reported NYHA Class I or II at 5 years

Echocardiographic findings2

Consistent mean pressure gradients out to 5 years.

Echocardiographic finding of Avalus PERIGON clinical study



Design benefits

Avalus™ is more than just another valve — it’s designed with lifetime patient management in mind.

100% coaptation
and 0% doubt

The Avalus™ valve features a dual component, non-deformable base and flexible stent posts designed for:

  • Excellent leaflet coaptation3,4
  • Minimal central regurgitation with no central jet
  • Supra-annular placement

Avalus™ is built circular to stay circular 

Circularity is crucial, but not all aortic valves are circular. Noncircular or deformed surgical valves can have decreased durability and poor blood flow.5-8 The non-deformable polymer base of Avalus™ surgical aortic valve is designed to:

  • Enable efficient blood flow
  • Allow regular leaflets motion
  • Increase valve durability
  • Can benefit future valve-in-valve procedures

Importance of circularity

AOA tissue treatment

25+ years of
clinical use

  • Utilized in both surgical and transcatheter products (bovine pericardial, porcine root, porcine pericardial) — used in tens of thousands of patients
  • Demonstrated to reduce calcium
  • Stored in a solution of glutaraldehyde to continuously reduce free aldehydes

No clinical data is available that evaluates the long-term impact of AOA treatment in patients.

Future valve-in-valve (ViV)

Lifetime management

  • The geometry and stable hemodynamic performance of Avalus™ enables possible future valve-in-valve (ViV) replacement.
  • The base frame contains barium sulfate for radiopacity to facilitate ViV procedures.
  • The interior mounted leaflets help mitigate risk of coronary obstruction in ViV procedures.

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Heart Valves Surgical portfolio

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PERIGON Pivotal Trial data on file as of October 2021.


Medtronic data on file.


Medtronic data on file. This data may not be indicative of clinical performance.


Avalus™ Bioprosthesis Instructions For Use. 2017. Medtronic. Based on one-year clinical data from the PERIGON Pivotal Trial for the Avalus™ valve.


Gunning PS, Saikrishnan N, Yoganathan AP, McNamara LM. Total ellipse of the heart valve: the impact of eccentric stent distortion on the regional dynamic deformation of pericardial tissue leaflets of a transcatheter aortic valve replacement. J R Soc Interface. December 6, 2015;12(113):20150737.


Flameng W, Herregods M-C, Vercalsteren M, Herijgers P, Bogaerts K, Meuris B. Prosthesis-patient mismatch predicts structural valve degeneration in bioprosthetic heart valves. Circulation. May 18, 2010;121(19):2123-2129.


Sritharan D, Fathi P, Weaver JD, Retta SM, Wu C, Duraiswamy N. Impact of Clinically Relevant Elliptical Deformations on the Damage Patterns of Sagging and Stretched Leaflets in a Bioprosthetic Heart Valve. Cardiovasc Eng Technol. September 2018;9(3):351-364.


Ruzicka DJ, Hettich I, Hutter A, et al. The complete supraannular concept. Circulation. 2009;120[suppl 1]:S139-S145.