Avalus Bioprosthesis for Heart Valve Replacement

The Avalus bioprosthesis is a pericardial aortic surgical valve designed for better overall performance, improved implant experience, and a contemporary design to facilitate future valve-in-valve (ViV).

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Overview

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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% none/trace transvalvular AR through 5 years
  • 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.

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 coaptation3,4
  • 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

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.

START OF NEW GLOBAL PRODUCT PAGE LAYOUT AND CONTENT

Designed for Life. See Avalus in action.

Our Avalus valve is the next-generation stented pericardial aortic valve — a powerful synergy of over 40 years of industry experience and proven valve design — for excellent implantability for you and performance for your patients.

Product Details

Avalus five-year PERIGON clinical update thumbnail

Proven, Strong Hemodynamics1,2

Read about the clinical success of the Avalus.

  • Avalus proven in small aortic annuli
  • Avalus 5-year data shows 0 SVD

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A Design Platform for Long-term Durability*

Interior-mounted leaflets minimize damaging contact with the frame — a design platform for long-term durability.

Avalus supra-annular design detail with callouts on white background
  1. Supra-annular design to enhance hemodynamics3,4
  2. Three laser-cut bovine pericardial leaflets matched for thickness and deflection to provide consistent performance
  3. Two-part polymer frame minimizes stress zones on leaflets
  4. Sewing markers facilitate suture placement and valve orientation

AOA™ tissue treatment* to mitigate calcification — over 20 years of clinical use in the Medtronic surgical tissue valve portfolio.1,2

STRONG CLINICAL PERFORMANCE

The PERIGON 5 years Pivotal Trial demonstrated safety and effectiveness of Avalus™ Bioprosthesis1.​

EXCELLENT DURABILITY

NO SVD through 5 years

EXCELLENT FUNCTIONALITY

> 95% of subjects had less than mild central regurgitation at 5 years

STABLE HEMODYNAMICS

Stable low mean gradients over 5 years in all valve sizes

STABLE NYHA CLASS

> 95% of subjects reported NYHA class I or II at 5 years

The PERIGON Pivotal trial confirmed substantial improvements of peak and mean aortic pressure gradients and mean EOA after implantation of the Avalus™ Bioprosthesis, and these improvements were maintained over time1.

Mean Gradients and Effective Orifice Area

Echocardiographic Findings

The PERIGON Pivotal trial demonstrated no trace or extremely low cases of severe transvalvular regurgitation after Avalus™ Bioprosthesis implantation1

Transvalvular Regurgitation ​

Transvalvular Regurgitation

IMPLANTERS EXPERIENCE ​

Sizing and surgical technique are critical to hemodynamic and durability outcomes in patients receiving surgical aortic valve treatment. Watch the video with Prof. Michael G. Moront and learn about his experience in implanting Avalus™ Bioprosthesis.

Ease of Implant for You

Decorative element
Polyetheretherketone (PEEK) polymer stent provides strength and flexibility and offers resistance to permanent deformation.
Avalus sewing cuff on blue gradient background and valve holder on gray gradient background
  • Soft and pliable sewing cuff facilitates needle penetration, suture placement, and valve seating for an improved implant experience
  • Lower valve profile and narrow commissure posts expand ostia clearance and give you more space for knot tying
  • Streamlined valve holder improves visibility in both standard and minimally invasive approaches
  • Simple one-cut release

Performance and Lifetime Management for Your Patients

  • Valve dimensions and geometry enable future ViV replacements
  • PEEK base frame impregnated with barium sulfate provides for radiopacity and visibility
  • Polymer frame mitigates the risk of potential metal-on-metal corrosion with transcatheter stent materials
  • MRI safe in all MR environments without conditions
Avalus valve on blue gradient background and frame design on gray gradient background

Designed to achieve 100% coaptation and minimize central regurgitation.

Icon with plus sign in circle and Avalus valve on blue gradient background

Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance.

Product Specifications and Ordering Information

Avalus Valve Ordering and Specifications

Avalus Valve Order Number

Valve Size

(mm)

Stent Diameter (TAD

(mm)

Internal Orifice Diameter‡ 

(mm)

External Sewing Ring Diameter 

(mm)

Valve Profile Height

(mm)

Aortic Protrusion

(mm)

 

 

(1)

(2)

(2a)

(3)

(4)

(5)

40019

19

19

17.5

18

27.0

13.0

11.0

40021

21

21

19.5

20

29.0

14.0

12.0

40023

23

23

21.5

22

31.0

15.0

13.0

40025

25

25

23.5

24

33.0

16.0

14.0

40027

27

27

25.5

26

36.0

17.0

15.0

40029

29

29

27.5

28

38.0

18.0

16.0

Avalus valve illustration with sizing detail

Avalus Valve Accessories

Order Number

Description

7420

Valve Handle

7400S

Avalus Sizers

T7400

Tray, Accessory, Avalus

Additional Resources

Contact Information

LifeLine Cardiovascular
Technical Support

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Medical Education

Training, education, and collaboration on the treatment of mitral and tricuspid valve disease.

Learn More
*

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

TAD — tissue annulus diameter.

Measurement shows stent frame including tissue (2) and stent frame excluding tissue (2a).

References

1

Tadokoro N, Fukushima S, Shimahara Y, et al. Comparison of safety and haemodynamic performance between the Avalus™ stented aortic valve bioprosthesis and Magna™ valve in Japanese patients. Gen Thorac Cardiovasc Surg. July 2021;69(7):1060-1069.

2

The latest results of the Perigon Study, presented by Prof. Dr. Robert J.M. Klautz during EACTS 2021. The PERIGON Pivotal Trial regarding the Avalus valve is a prospective, interventional, nonrandomized, worldwide, multi-site trial, with each center following a common protocol. The study was designed in accordance with the recommendations of the EN ISO 5840:2009 standard for cardiac valve prostheses and the U.S. Food and Drug Administration (FDA) Heart Valve Guidance (2010; DRAFT) and conducted in accordance with the Declaration of Helsinki and good clinical practice guidelines. Valve-related events and deaths were adjudicated by an independent clinical events committee (CEC). All study echocardiograms were analyzed by an independent core laboratory (MedStar Health Research Institute, Washington, D.C.). Safety oversight was provided by an independent data and safety monitoring board (DSMB). This trial is registered at www.clinicaltrials.gov, NCT02088554.

3

Medtronic Freestyle™ aortic root bioprosthesis was first implanted clinically in August 1992. Freestyle Aortic Root Bioprosthesis 15-Year Clinical Compendium. © 2016 Medtronic.

4

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;120(11 Suppl):S139-145.

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