Avalus. 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.

See complete trial results

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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References

1

PERIGON Pivotal Trial data on file as of October 2021.

2

Medtronic data on file.

3

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

4

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

5

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.

6

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.

7

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.

8

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