Healthcare Professionals
Avalus™ Bioprosthesis
Pericardial Aortic Surgical Valve
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
The PERIGON Pivotal trial demonstrated no trace or extremely low cases of severe transvalvular regurgitation after Avalus™ Bioprosthesis implantation1.
Transvalvular Regurgitation
Product details
A design platform for long-term durability
- AOA™ tissue treatment to mitigate calcification*
- Interior-mounted leaflets minimize damaging contact with the frame
Improved implant experience
- 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
- 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
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.