Healthcare Professionals
Avalus™ Bioprosthesis
The Avalus™ bioprosthesis is our first generation bovine pericardial valve.
The Avalus™ valve is built to last and delivers excellent hemodynamic performance 1 With lifetime patient management in mind, Avalus design benefits include:
- A non-deformable polyetheretherketone (PEEK) polymer stent to maintain circularity, which can help drive consistent hemodynamics and durability2–4
- A dual component with non-deformable base and flexible stent posts designed for 100% coaptation1,3,4
- Innovative AOA™ anti-calcification tissue treatment designed to enhance durability†
- Features to facilitate future valve-in-valve (ViV) procedures
Risks may include infection, surgical complications, stroke, endocarditis, and death.
† 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.
Features
Avalus™ bioprosthesis
Designed for life
Real-world clinical evidence
Ongoing clinical updates you can rely on
SAVR hemodynamic valve normals
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.
Data insights
This is the most robust surgical aortic valve replacement (SAVR) hemodynamic valve normals analysis to date.§a
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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.
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.
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 |
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.