Introducing Avalus Ultra™
The next generation aortic bioprosthesis is based on the established Avalus™ valve with 10+ years of clinical use, long-term durability and Industry-leading EOA. Avalus Ultra™ is designed to leverage this knowlege to create our most advanced surgical aortic tissue valve. A valve that is Fit for the future, right from the start.
Designed for durable long-term performance*
A decade of reliable clinical experience of the Avalus™ valve with its unique nondeformable, circular base made from PEEK for lasting stability during and after implant1,3.
Engineered for ease of implant
The reduced valve dimensions allows for improved ease of implant, and the new sizers are designed to facilitate valve size selection for each patient's anatomy.
Excellent fit for lifelong patient care
Circular TAVI landing zone: a non-deformable base2,3 with a generous internal diameter paired with the cylindrical opening of the stent posts may help facilitate accurate TAVI placement.
Excellent & stable hemodynamics*
Stable Gradients for both younger (≤65) and older (>65) patients4, supported by the solid clinical evidence of the Avalus™ valve on a large 1100+ patients’ cohort.
Research development
The next generation aortic tissue valve, built on a strong foundation and a decade of experience of Avalus™ valve
PERIGON First implant
The largest prospective study on a latest generation surgical aortic valve.
Comparative in-vitro fatigue test5
600 min cycles, mimicking 15 years of use
Avalus clinical confidence (ACE)6
PERIGON 5-year data
Further clinical studies
- Young patients analysis7
- MICS implantability analysis8
Echo Valve Normals9
PERIGON 7-year data10
Initiation of Avalus Ultra™ Post-Approval Study (PAS)
*
Demonstrated by the Avalus™ valve. AWT and animal testing has been completed with Avalus Ultra™
1
Klautz RJM, Dagenais F, Reardon MJ, et al. Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes. Eur J Cardiothorac Surg. August 2022;62(3):ezac374.
2
Based on internal test report D00997823, Avalus Ultra™ Full Valve Stiffness Design Verification Report.
3
Based on internal test report D00998399, Design Characterization Report: External Sewing Ring Diameter, Valve Housing External Diameter, and Inflow Orifice.
4
Kiaii BB, Moront MG, Patel HJ, Ruel M, Bensari FN, Kress DC, Liu F, Klautz RJM, Sabik JF 3rd. Outcomes of Surgical Bioprosthetic Aortic Valve Replacement in Patients Aged ≤65 and >65 Years. Ann Thorac Surg. 2023 Sep;116(3):483-490. doi: 10.1016/j.athoracsur.2021.12.057. Epub 2022 Jan 20.
5
Vriesendorp MD, de Lind van Wijngaarden RAF, Rao V, Moront MG, Patel HJ, Sarnowski E, Vatanpour S, Klautz RJM. An in vitro comparison of internally versus externally mounted leaflets in surgical aortic bioprostheses. Interact Cardiovasc Thorac Surg. 2020 Mar 1;30(3):417- 423. doi: 10.1093/icvts/ivz277
6
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. February 18–21, 2024
7
Kiaii BB, Moront MG, Patel JH, et al. Outcomes of surgical bioprosthetic aortic valve replacement in patients aged ≤65 and >65 years. Ann Thorac Surg. September 2023;116(3):483-490.
8
Velders BJJ, Vriesendorp MD, Reardon MJ, et al. Minimally invasive aortic valve replacement in contemporary practice: clinical and hemodynamic performance from a prospective multicenter trial. Thorac Cardiovasc Surg. August 2023;71(5):387-397
9
Klautz RJM, Rao V, Reardon MJ et al., Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024;65(5):ezae122 10. Sabik JF 3rd, Rao V, Dagenais F, Moront MG, Reardon MJ, Patel HJ, Oh JK, Fukuhara S, Labrousse L, Günzinger R, Baig K, Ito S, Wu T, Klautz RJM. 7-Year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicenter analysis. Eur J Cardiothorac Surg. 2024 Nov 20:ezae414. doi: 1093/ejcts/ezae414.
10
10. Sabik JF 3rd, Rao V, Dagenais F, Moront MG, Reardon MJ, Patel HJ, Oh JK, Fukuhara S, Labrousse L, Günzinger R, Baig K, Ito S, Wu T, Klautz RJM. 7-Year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicenter analysis. Eur J Cardiothorac Surg. 2024 Nov 20:ezae414. doi: 10.1093/ejcts/ezae414.
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