Pericardial Aortic Surgical Valve
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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.
GOOD SAFETY PROFILE 100% FREEDOM FROM SVD THROUGH 4 YEARS
>94% OF PATIENTS OVER 4-5 YEARS
WITH LESS THAN MILD CENTRAL
>72% OF PATIENTS CONTINUE REPORTED NYHA CLASS I AT 4&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.
PERIGON Pivotal Trial data on file as of January 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.
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.