Healthcare Professionals

Avalus™ Bioprosthesis

Pericardial Aortic Surgical Valve

  • Medtronic Avalus Bioprosthesis

 

Advanced and efficient 

Avalus™ Bioprosthesis is the Next Generation stented pericardial aortic valve, developed by Medtronic to advance cardiac surgical care. A powerful synergy of experience and innovations for better performance, improved implant experience and life-time patient management. 

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.

Product details

A design platform for long-term durability

  • AOA™ tissue treatment to mitigate calcification*
  • Interior-mounted leaflets minimize damaging  contact with the frame

Avalus features

Improved implant experience

Avalus
  • 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 expands ostia clearance and gives 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

Avalus
  • Designed to achieve 100% coaptation and minimize central regurgitation
  • 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

Downloads

pdf Comparative Clinical Study Summary (.pdf)

1.2MB

Comparative Clinical Study Summary
pdf Latest Clinical Summary (.pdf)

291KB

Latest Clinical Summary
1

PERIGON Pivotal Trial data on file as of August 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.

2

Ruzicka D.J. Hettich I, Hutter A, et al. The complete superannular concept. Circulation 2009; 120 (suppl 1):5139-5145.

*

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