tissue valves and conduits
Avalus Ultra™ bioprosthesis
Avalus Ultra™ bioprosthesis: a next-generation bovine pericardial valve with a circular base frame and AOA tissue treatment for aortic valve replacement.
Overview
Fit for the future, right from the start.
The Avalus Ultra™ bioprosthesis is designed to facilitate ease of use at implant. Delivering straightforward sizing for the right valve fit and clear visibility for future valve-in-valve procedures, this next-generation valve is a premier choice for cardiac surgeons who want a valve that's fit for the future, right from the start.1
Features
Designed to facilitate 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 designed to facilitate needle penetration, secure valve seating and exceptionally low paravalvular leak (PVL) rates.1–4
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 fit.1
Focused on lifetime patient management
Enhanced radiopaque marker
- The valve dimensions and geometry helps to enable future valve-in-valve replacements.5,6
- 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 IFU for complete details.†,7
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.8-11
- Nondeformable polyetheretherketone (PEEK) base is designed to allow the valve to maintain circularity during and after implant.5,6
- Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance.5,8–12
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 EOAs, stable low gradients, and valve circularity.12,13
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.§,14–18
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
Mean pressure gradients (MPG) at one year
Learn more about the pooled SAVR data set.
Surgical valve replacement risks may include infection, surgical complications, stroke, endocarditis, and death.
‡ 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
| Item 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 |
™* 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. Based on internal test report 10111582, Nexus human factors engineering (HFE) validation report.
4. 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.
5. Based on internal test report D00997823 — Avalus Ultra™ full valve stiffness design verification report.
6. Based on internal test report D00998399 — Design characterization report: external sewing ring diameter, valve housing external diameter, and inflow orifice diameter of Avalus Ultra™.
7. Based on internal document M034967C001 Avalus Ultra™ IFU.
8. 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.
9. 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.
10. 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.
11. Ruzicka DJ, Hettich I, Hutter A, et al. The complete supraannular concept. Circulation. 2009;120[suppl 1]:S139–S145. doi.org/10.1161/CIRCULATIONAHA.109.844332.
12. 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.
13. 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, USA.
14. Klautz RJM, Kappetein AP, Lange R, et al. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg. 2017;52(3):425–431. doi: 10.1093/ejcts/ezx066.
15. 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.
16. 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.
17. 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.
18. 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.