Healthcare Professionals

Avalus™ Bioprosthesis

Pericardial Aortic Surgical Valve

Overview

With more than 40 years of industry experience, we took proven valve design concepts and adapted them for excellent implantability for you and performance for your patients.

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

Mitigating calcification with AOATM tissue treatment

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

Important Labeling Information for Europe

Indications for Use: The Avalus bioprosthesis is indicated for the replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic valve for patients 70 years of age and older.

Contraindications: Do not use the valve if its use is not in the best interest of the patient. Evaluate all of the risks involved, including the anatomy and pathology observed at the time of surgery.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet-related), transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), prosthesis regurgitation, stroke, structural deterioration (calcification, leaflet tear, stenosis, other), thromboembolism, and valve thrombosis. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.

*

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

1

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