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Avalus Cor-Knot® fasteners image

SMART AVR WITH
 Avalus™
BIOPROSTHESIS
 AND Cor-Knot®
FASTENERS

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Meet your patients’ need for minimally invasive procedures: choose Avalus™ Bioprosthesis and COR-KNOT® for SMART AVR.

5 features of Avalus™ Bioprosthesis and COR-KNOT® to advance your MICS program:

  • Straightforward and fast procedure
  • Minimally invasive access
  • Avoid compromises of sutureless valves 
  • Reliable design with internally mounted leaflets
  • TAV-in-SAV ready

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 ​

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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 Echocardiographic Graph

Product Details

A design platform for long-term durability

  • AOA™ tissue treatment to mitigate calcification3
  • Interior-mounted leaflets minimize damaging  contact with the frame

Avalus features

References

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

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

4

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

DISCLAIMER

Important Reminder: Please contact your local LSI Solutions® representative to order COR-KNOT®. This product is not available from Medtronic. The LSI logo, LSI SOLUTIONS and COR-KNOT® are trademarks and registered trademarks of LSI Solutions, Inc.