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
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.
Avalus™ Experience
Product Details
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
A Design Platform for Long-term Durability*
Interior-mounted leaflets minimize damaging contact with the frame — a design platform for long-term durability.
- Supra-annular design to enhance hemodynamics3,4
- Three laser-cut bovine pericardial leaflets matched for thickness and deflection to provide consistent performance
- Two-part polymer frame minimizes stress zones on leaflets
- 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
Ease of Implant for You
Polyetheretherketone (PEEK) polymer stent provides strength and flexibility and offers resistance to permanent deformation.
- 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
Designed to achieve 100% coaptation and minimize central regurgitation.
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 |
37.0 |
18.0 |
16.0 |
Avalus Valve Accessories
| Order Number |
Description |
|---|---|
| 7420 |
Valve Handle |
| 7400S |
Avalus Sizers |
| T7400 |
Tray, Accessory, Avalus |
Additional Resources
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.