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Tissue valves and conduits

Avalus Ultra™ bioprosthesis

<p>Avalus Ultra™ bioprosthesis:&nbsp;A next-generation bovine pericardial valve for aortic valve replacement.</p>

Ordering information
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Features

Engineered for ease of implant

Low valve profile

  • The reduced Avalus Ultra™ valve profile is designed to facilitate ease of implant.1,2
  • A flexible and pliable sewing cuff is designed to facilitate needle penetration, secure valve seating and exceptionally low paravalvular leak (PVL) rates as demonstrated by the Avalus™ valve.1–3,5

Straightforward sizing

  • The replica end atraumatic commissure post shape enhances visibility during sizing and helps to reduce the risk of obstructing patient’s anatomy.1,2
  • The simulated cuff on the barrel end of the sizer reflects the implanted valve profile.
  • Avalus Ultra™ valve sizer allows for an easy valve fit1
Portrait of a male healthcare professional in an outdoor setting wearing blue scrubs, a stethoscope, and smiling

Focused on lifetime patient management

Fit for future TAV-in-SAV

  • The valve dimensions and geometry help to enable future valve-in-valve replacements.6,7
  • The radiopaque coil helps enhance visibility of the Avalus Ultra™ valve on fluoroscopy imaging for valve-in-valve procedures.1,2
  • The radiopaque coil has a unique tantalum badge that helps identify which valve a patient has implanted.
  • MRI Conditional: Certain conditions have shown to be safe to use under MRI. Reference the instructions for use for complete details.†,8

Circular base frame

  • Circularity is crucial, but not all aortic valves maintain circularity. Noncircular or deformed surgical valves can have decreased durability and poor blood flow.9–12
  • Nondeformable polyetheretherketone (PEEK) base is designed to allow the valve to maintain circularity during and after implant4,6,7
  • Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance6,9–13
Avalus Ultra™ bioprosthesis shown via fluoroscopic imaging to illustrate the radiopaque coil

Clinical evidence

Trusted performance,‡ established in evidence

The Avalus Ultra™ valve’s design is built on the 10 years of clinical experience with the Avalus™ valve. The Avalus Ultra™ valve is supported by the robust and real-world evidence of the Avalus™ valve, which demonstrates durability, excellent effective orifice areas (EOAs), stable low gradients, and valve circularity.4,13

Medtronic and Mayo Clinic partnered together to pool data from four large clinical trials of surgical aortic valve replacement (SAVR) and created the largest surgical valve data set with echocardiograms evaluated by a single core lab to date.§,3,14–17

The reference values reported in the data set can aid in evaluating whether an implanted valve is functioning normally after valve replacement. See below how the different valves performed at one year after implant.

Effective orifice area (EOA) at one year

Graph of EOA results at one year post-implant

Mean pressure gradients (MPG) at one year

Graph of mean pressure gradient results at one year post-implant

* some products may not be licenced as per the Canadian Law.

‡ Performance is based on data gathered from the Avalus™ valve.

§ Although all echos in the data set were read by a single core lab and these are the most robust SAVR valve normals to-date, limitations exist including differences in patient population among individual studies.

Ordering information

  1. Stent diameter
  2. Internal orifice diameter (stent frame with tissue) and internal orifice diameter (stent frame without tissue)
  3. External sewing ring diameter
  4. Valve profile height
  5. Aortic protrusion
Outlined illustration of the Avalus Ultra™ bioprosthesis with five numbered callouts
Order number Valve size Stent diameter Internal orifice diameter (stent frame with tissue) Internal orifice diameter (stent frame without tissue) External sewing ring diameter Valve profile height Aortic protrusion
400U19 19 mm 19 mm 17.5 mm 18 mm 26.0 mm 13.0 mm 11.0 mm
400U21 21 mm 21 mm 19.5 mm 20 mm 28.0 mm 14.0 mm 12.0 mm
400U23 23 mm 23 mm 21.5 mm 22 mm 30.0 mm 15.0 mm 13.0 mm
400U25 25 mm 25 mm 23.5 mm 24 mm 32.0 mm 16.0 mm 14.0 mm
400U27 27 mm 27 mm 25.5 mm 26 mm 35.0 mm 17.0 mm 15.0 mm
400U29 29 mm 29 mm 27.5 mm 28 mm 37.0 mm 18.0 mm 16.0 mm

 

Accessories

Item number Description
7420 Valve handle
7400SU Avalus Ultra™ sizer
T7400U Avalus Ultra™ tray
7779 Jar wrench

 

Resources

Similar products

TM* Third-party brands are trademarks of their respective owners.

† MR Conditional is defined as less than 1% of nickel in the valve.

  1. Based on internal test report (D00998354), Avalus Ultra™ HFE design validation test report.
  2. Based on internal document (D00437207), Avalus Ultra™ design concept.
  3. Klautz RJM, Rao V, Reardon MJ, et al. Hemodynamic function of contemporary surgical aortic valves 1 year postimplant. Abstract presented at: 37th Annual Meeting of the European Association for Cardio-Thoracic Surgery, Vienna, Austria. 2023.
  4. Klautz RJM, Dagenais F, Reardon MJ, et al. Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes. Eur J Cardiothorac Surg. 2022;62(3):ezac374. doi: 10.1093/ejcts/ezac374.

  1. Based on internal test report 10111582, Nexus human factors engineering (HFE) validation.
  2. Based on internal test report D00997823, Avalus Ultra™ full valve stiffness design verification.
  3. Based on internal test report D00998399, Design characterization report: external sewing ring diameter, valve housing external diameter, and inflow orifice diameter of Avalus Ultra™.
  4. Based on document M034967C001, Avalus Ultra™ instructions for use.
  5. Gunning PS, Saikrishnan N, Yoganathan AP, McNamara LM. Total ellipse of the heart valve: the impact of eccentric stent distortion on the regional dynamic deformation of pericardial tissue leaflets of a transcatheter aortic valve replacement. J R Soc Interface. 2015;12(113):20150737. doi: 10.1098/rsif.2015.0737.
  6. Flameng W, Herregods MC, Vercalsteren M, Herijgers P, Bogaerts K, Meuris B. Prosthesis-patient mismatch predicts structural valve degeneration in bioprosthetic heart valves. Circulation. 2010;121(19):2123–2129. doi: 10.1161/CIRCULATIONAHA.109.901272.
  7. Sritharan D, Fathi P, Weaver JD, Retta SM, Wu C, Duraiswamy N. Impact of clinically relevant elliptical deformations on the damage patterns of sagging and stretched leaflets in a bioprosthetic heart valve. Cardiovasc Eng Technol. 2018;9(3):351–364. doi: 10.1007/s13239-018-0366-x.
  8. Ruzicka DJ, Hettich I, Hutter A, et al. The complete supraannular concept: in vivo hemodynamics of bovine and porcine aortic bioprostheses. Circulation. 2009;120(suppl 1):S139–S145. doi.org/10.1161/CIRCULATIONAHA.109.844332.
  9. Verbelen T, Roussel JC, Cathenis K, et al. Real-world data on the Avalus™ pericardial aortic valve: initial results from a prospective, multi-center registry. Presented at Heart Valve Society 2024; Boston, MA.
  10. Sabik JF III, Rao V, Lange R, et al. One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis. J Thorac Cardiovasc Surg. 2018;156(4):1368–1377.e5. doi: 10.1016/j.jtcvs.2018.03.171.
  11. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370(19):1790–1798. doi: 10.1056/NEJMoa1400590.
  12. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376(14):1321–1331. doi: 10.1056/NEJMoa1700456.
  13. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380(18):1706–1715. doi: 10.1056/NEJMoa1816885.

This product is licenced with Health Canada as AVALUS ULTRA BIOPROSTHESIS on Health Canada licence number 112800.