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Avalus™ valve.  Designed for life.

Intentionally designed for durability and performance, Avalus bioprosthesis is our most advanced and effective surgical aortic tissue valve engineered for lifetime patient management.

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Clinical data

Avalus-Imagery

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 full clinical compendium (opens new window)

Key clinical highlights1

  • Durability: 0 SVD through 5 years
  • Functionality: > 95% of patients reported NYHA Class I or II at 5 years
  • Efficiency: Stable low mean gradients through 5 years
  • Safety: 98.5% freedom from valve-related mortality through 5 years

SVD was defined as a confirmed intrinsic abnormality causing stenosis or regurgitation.

Echocardiographic findings1

Consistent mean pressure gradients out to 5 years.

Echocardiographic findings from the PERIGON Pivotal Trial clinical study

 

 

Risks may include infection, surgical complications, stroke, endocarditis, and death.

Design benefits

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

Designed for 100% coaptation and 0% doubt

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

  • Excellent leaflet coaptation3
  • Coapts smoothly and fully to effectively reduce central jet of blood flow
  • Supra-annular placement
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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.4-8 The non-deformable polymer base of Avalus surgical aortic valve is designed to:

  • Enable efficient blood flow
  • Allow regular leaflet motion
  • Increase valve durability
  • Can benefit future valve-in-valve procedures
Importance of circularity (opens new window)

AOA tissue treatment

25+ years of clinical use

The Medtronic amino oleic acid (AOA™) treatment is an innovative tissue treatment used across a suite of Medtronic devices to help drive durable valve replacements and patient lifetime management.†

  • Utilized in both surgical and transcatheter products (bovine pericardial, porcine root, porcine pericardial) — used in over half a million patients for over 25 years.
  • Demonstrated to reduce calcium.9
  • Stored in a solution of glutaraldehyde to continuously reduce free aldehydes.

†The benefits of AOA tissue treatment have been demonstrated through animal testing. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted.

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Future valve-in-valve (ViV)

Lifetime management 

  • The geometry and stable hemodynamic performance of Avalus enables possible future valve-in-valve (ViV) replacement.1
  • 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

Klautz RJM, Dagenais F, Reardon MJ, et al. Surgical Aortic Valve Replacement with a Stented Pericardial Bioprosthesis: 5 Year Outcomes. Eur J Cardiothorac Surg. August 3, 2022;62(3):ezac374.

2

Sohn SH, Kim JS, Choi JW, et al. Preliminary Report from a Randomized Controlled Trial Comparing Two Bovine Pericardial Valves. Thorac Cardiovasc Surg. Published online August 2, 2022.

3

Vriesendorp MD, de Lind van Wijngaarden RAF, Rao V, et al. An in vitro comparison of internally versus externally mounted leaflets in surgical aortic bioprostheses. Interact Cardiovasc Thorac Surg. March 1, 2020;30(3):417-423.

4

Faure ME, Sucha D, Schwartz FR, et al. Surgically implanted aortic valve bioprostheses deform after implantation: insights from computed tomography. Eur Radiol. May 2020;30(5):2651-2657.

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: in vivo hemodynamics of bovine and porcine aortic bioprostheses. Circulation. September 15, 2009;S139-S145.

9

Weber PA, Jouan J, Matsunaga A, et al. Evidence of mitigated calcification of the Mosaic versus Hancock Standard valve xenograt in the mitral position of young sheep. J Thorac Cardiovasc Surg. November 2006;132(5):1137-1143.