Pericardial Aortic Surgical Valve
You just clicked a link to go to another website. If you continue, you may go to a site run by someone else.
It is possible that some of the products on the other site are not approved in your region or country.
Your browser is out of date
With an updated browser, you will have a better Medtronic website experience. Update my browser now.
The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N°2011-2012 dated 29th December 2011, article 34.
Click “OK” to confirm you are a Healthcare Professional.
Pericardial Aortic Surgical Valve
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.
With Avalus™ Bioprosthesis your patients will benefit from efficient and stable hemodynamics, proven by high-quality clinical evidence1.
4-5 YEARS STABLE LOW MEAN GRADIENT,
COMPARABLE TO OR LOWER THAN OTHER VALVES1
>95% OF PATIENTS OVER 4-5 YEARS
WITH LESS THAN MILD CENTRAL
2-3 TIMES LESS CASES OF TRANSVALVULAR
COMPARED TO OTHER VALVES2
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.
When compared with other stented aortic valves, evaluated in the TRIBECA study3, Avalus™ Bioprosthesis compares favourably:
The latest results of the Perigon Study, presented by Prof. Dr. Robert J.M. Klautz during EACTS 2020. 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.
The Avalus™ TVR data from the PERIGON study, compared to the TVR results of Magna Ease™ and Trifecta™ valves as presented in Colli A, Marchetto G,Salizzoni S, Rinaldi M, Di MarcoL, Pacini Det al. The TRIBECAstudy: (TRI)fecta (B)ioprosthesis (E)valuation versus (C)arpentier Magna-Easein (A)ortic position. Eur JCardiothorac Surg 2016;49:478–85
Colli A, Marchetto G,Salizzoni S, Rinaldi M, Di MarcoL, Pacini Det al. The TRIBECAstudy: (TRI)fecta (B)ioprosthesis (E)valuation versus (C)arpentier Magna-Easein (A)ortic position. Eur JCardiothorac Surg 2016;49:478–85
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.