Tissue valves and conduits

Avalus™ bioprosthesis

<p>The Avalus™ bioprosthesis is our first generation bovine pericardial valve.</p>

Ordering information
Contact a representative

Features

Avalus™ bioprosthesis
Designed for life

This is an image of an older female smiling on the beach with a small Avalus™ valve product image encircled on top.

Real-world clinical evidence

Ongoing clinical updates you can rely on

Quality data. Better heart decisions.

Discover the largest data set of contemporary surgical aortic valves, analyzed by a single core lab.1 Using this data set, Medtronic created a tool for you that is a novel, robust instrument for evaluating valve performance. Discover the ultimate valve performance tool you've been waiting for.

See the data (open in new window)

Data insights

This is the most robust surgical aortic valve replacement (SAVR) hemodynamic valve normals analysis to date.§

Read full presentation

Watch the EACTS 2023 Valve Normals podium presentation by Robert J.M. Klautz, M.D., Ph.D.

Results from the prospective, multicenter Avalus Clinical ConfidencE (ACE) registry

The ACE Registry was designed to build real-world evidence for the Avalus™ pericardial aortic valve, including 1,000 patients and 40 plus centers enrolled across Europe.

ACE Registry methods and outcomes

  • Study endpoints: Mortality, stroke, bleeding complications, pacemaker need, ICU and hospital stay, prosthetic valve function, reintervention (VARC-2)
  • Recruitment period: 2021–2024, 1,000 patients, 40+ centers across Europe.
  • The initial data demonstrates excellent early clinical and hemodynamic outcomes, including:5
    • Very low rates of early major events, prosthesis-patient mismatch (PPM) and paravalvular regurgitation (PVR).
    • Low gradients
    • Large EOAs
See the results for the first 350+ patients (open in new window)

The proof is in your patient.

  • The PERIGON Pivotal Trial is the largest prospective trial for pericardial stented surgical valves with 38 centers globally with more than 1,100 patients enrolled.
  • All study echocardiograms were analyzed by an independent core laboratory.
  • The mean age was 70.2 ± 9.0 years (ranged from 21 to 91 years).

 

This is an image of an older male smiling while wearing a backpack on a hike.

Key clinical highlights6

  • Durability: 0 structural valve deterioration (SVD) through 5 years
  • Functionality: > 95% of patients reported NYHA Class I or II at 5 years
  • Efficiency: stable low mean gradients through 5 years
  • Safety: 98.5% freedom from valve-related mortality through 5 years

SVD was defined as a confirmed intrinsic abnormality causing stenosis or regurgitation.

Early hemodynamic outcomes7

The PROVE-PERI study — not sponsored by Medtronic — compares Medtronic Avalus™ valve and Edwards Magna Ease™* valve.

  • First and only randomized study comparing Avalus™ valve to Magna Ease valve.
  • Found comparable early hemodynamic results in all valve sizes.
  • Found Avalus™ valve demonstrated significantly lower gradients in 19 mm valve size compared to Magna Ease 19 mm valve size (p=0.03).
  • Clinical outcomes for Avalus™ valves and Magna Ease valves were similar.

Patient-centered benefits

The Avalus™ valve is more than just another valve — it’s designed with lifetime patient management in mind.

 

Designed for 100% coaptation and 0% doubt

The Avalus™ valve features a dual-component, non-deformable base and flexible stent posts designed for 100% coaptation, providing:

  • Industry-leading EOAs, low and stable MPGs1
  • Low rates of transvalvular regurgitation (TVR) and PVR1
  • Low rates of PPM in both controlled and real-world studies1,5

 

Avalus is built circular to stay circular.

Circularity is crucial, but not all aortic valves stay circular. Noncircular or deformed surgical valves can have decreased durability and poor blood flow.8–12 The non-deformable polymer base of Avalus™ surgical aortic valve is designed to8,9:

  • Enable efficient blood flow
  • Allow regular leaflet motion
  • Increase valve durability
  • Benefit future valve-in-valve procedures

AOA tissue treatment

 

More than 30 years of clinical use

Our innovative AOA™ tissue treatment that utilizes amino oleic acid has been used across a suite of Medtronic devices to help drive durable valve replacements and lifetime patient management.†

  • Utilized in both surgical and transcatheter products (bovine pericardial, porcine root, porcine pericardial) — used in over half a million patients for more than 30 years of clinical use.
  • Demonstrated to reduce calcium in animal testing.13
  • Stored in a solution of glutaraldehyde to continuously reduce free aldehydes.

† The benefits of AOA tissue treatment have been demonstrated through animal testing. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted.

View treatment brochure (open in new window)

Future valve-in-valve (ViV)

Lifetime management

  • The geometry and stable hemodynamic performance of Avalus™ valve enables possible future ViV replacement.6
  • The base frame contains barium sulfate for radiopacity to help facilitate ViV procedures.
  • The interior mounted leaflets help reduce risk of coronary obstruction in ViV procedures.

Download specifications

Avalus valve ordering information (open in new window)
This is a woman on a beach wearing a yellow shirt with her arms spread out and looking toward the sky.

Ordering information

Avalus™ valve

Item number Valve size (mm) Stent diameter (TAD◊) (mm) Internal orifice diameter (mm) External sewing ring diameter (mm) Valve profile height (mm) Aortic protrusion (mm)
(1) (2) (2a) (3) (4) (5)
40019 19 19 17.5 18 27.0 13.0 11.0
40021 21 21 19.5 20 29.0 14.0 12.0
40023 23 23 21.5 22 31.0 15.0 13.0
40025 25 25 23.5 24 33.0 16.0 14.0
40027 27 27 25.5 26 36.0 17.0 15.0  
40029 29 29 27.5 28.0 38.0 18.0 16.0

◊ TAD - Tissue Annulus Diameter
¶ Measurement shows stent frame including tissue (2) and stent frame excluding tissue (2a).


Avalus™ valve accessories

Item number Description
7420 Valve handle
7400S Avalus™ sizer
T7400 Avalus™ tray
7779 Jar wrench

Similar products

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

† The benefits of AOA tissue treatment have been demonstrated through animal testing. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted.

‡ The Avalus™ valve size 17 mm is only approved for commercial use in Japan. Given that the Avalus™ valve size 17 mm was included in the PERIGON Pivotal Trial, all data, including the 17 mm, from the Analysis Cohort is disclosed here. The Avalus™ 17 mm data accounts for less than 0.05% of the total echo data represented in this analysis.

§ Although all echos in the dataset were read by a single core lab and these are the most robust SAVR valve normals to-date, limitations exist. There were differences in the patient population among individual studies, including PERIGON enrolled patients with bicuspid anatomy and regurgitant lesions. The PERIGON and Evolut™ low risk patients were generally healthier than patients in the CoreValve™ high risk and SURTAVI studies. Number of each valve model varied. Perimount bovine pericardial specific models were not consistently collected. There were differences in how annulus size was measured in the Randomized Controlled Trials (RCTs) and the observational study. Lastly, when using the valve normals as reference values, a measured hemodynamic valve worse than the reference value does not necessarily mean a valve is failing.

  1. Klautz RJM, Rao V, Reardon MJ, et al. Hemodynamic function of contemporary surgical aortic valves 1 year postimplant. Paper presented at: 37th Annual Meeting of the European Association for Cardio-Thoracic Surgery; October 4–7, 2023; Vienna, Austria.
  2. Based on Avalus™ IFU, M971784A001 
  3. Based on internal document 10104149DOC, Nexus PEEK mechanical characterization report.
  4. Based on internal document 10104569DOC, Nexus FEA characterization test report.
  5. 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 HVS 2024.
  6. 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): doi: 10.1093/ejcts/ezac374.
  7. Sohn SH, Kim JS, Choi JW, et al. Preliminary report from a randomized controlled trial comparing two bovine pericardial valves. Thorac Cardiovasc Surg. 2023;71(8):648–655. doi: 10.1055/s-0042-1753494.
  8. Faure ME, Sucha D, Schwartz FR, et al. Surgically implanted aortic valve bioprostheses deform after implantation: insights from computed tomography. Eur Radiol. 2020;30(5):2651–2657. doi: 10.1007/s00330-019-06634-6.
  9. 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): doi: 10.1098/rsif.2015.0737.
  10. Flameng W, Herregods M-C, 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.
  11. 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.
  12. Ruzicka DJ, Hettich I, Hutter A, et al. The complete supraannular concept: in vivo hemodynamics of bovine and porcine aortic bioprostheses. Circulation. 2009;120(11 Suppl):S139–S145. doi: 10.1161/CIRCULATIONAHA.109.844332.
  13. Weber PA, Jouan J, Matsunaga A, et al. Evidence of mitigated calcification of the Mosaic versus Hancock Standard valve xenograt in the mitral position of young sheep. J Thorac Cardiovasc Surg. 2006;132(5):1137–1143. doi: 10.1016/j.jtcvs.2006.06.027.