Professionisti del settore sanitario

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. 

PROVEN STRONG HEMODYNAMICS

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 
REGURGITATION1

2-3 TIMES LESS CASES OF TRANSVALVULAR 
REGURGITATION
 
COMPARED TO OTHER VALVES2

CLINICAL EVIDENCE ​

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

Avalus Graph

The PERIGON Pivotal trial demonstrated no trace or extremely low cases of severe transvalvular regurgitation after Avalus™ Bioprosthesis implantation1

Transvalvular Regurgitation ​

Avalus Graph

When compared with other stented aortic valves, evaluated in the TRIBECA study3, Avalus™ Bioprosthesis compares favourably:

Avalus Graph

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

Please fill in the form below to request more information about Avalus

*Indica un campo obbligatorio

I tuoi dati saranno trattati e protetti in conformità con la nostra informativa sulla privacy.

Visualizza la nostra informativa sulla privacy

1

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.

2

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

3

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

4

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.

Nonostante le ragionevoli precauzioni prese nella redazione della presente pagina, Medtronic non si assume alcuna responsabilità per eventuali errori o omissioni, né per gli usi dei materiali ivi contenuti o le decisioni basate su tali usi. La presente pagina non contiene tutte le informazioni necessarie per una cura e un trattamento completo del paziente. Per tali ragioni, nessun soggetto può affidarsi alle informazioni ivi presentate per l'elaborazione di un programma di trattamento completo o per la terapia del paziente. Non vengono fornite garanzie, espresse o implicite, per quanto riguarda i contenuti della presente pagina o la relativa applicabilità a pazienti o circostanze specifiche. Per un elenco completo di indicazioni, controindicazioni, avvertenze e precauzioni dei dispositivi citati, si prega di consultare le istruzioni per l’uso dei singoli dispositivi. Medtronic non può essere ritenuta responsabile in alcun modo per danni dovuti all'utilizzo o alla interpretazione non corretta dei contenuti della presente pagina.