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 analyzed by an independent core laboratory.
Key study highlights1
- Durability: 0 SVD through 5 years
- Functionality: > 95% of patients had less than mild central regurgitation
- Efficiency: Stable low mean gradients through 5 years
- Safety: > 95% of patients reported NYHA Class I or II at 5 years
Echocardiographic findings2
Consistent mean pressure gradients out to 5 years.
Avalus™ is built circular to stay circular
Circularity is crucial, but not all aortic valves are circular. Noncircular or deformed surgical valves can have decreased durability and poor blood flow.5-8 The non-deformable polymer base of Avalus™ surgical aortic valve is designed to:
- Enable efficient blood flow
- Allow regular leaflets motion
- Increase valve durability
- Can benefit future valve-in-valve procedures
25+ years of
clinical use
- Utilized in both surgical and transcatheter products (bovine pericardial, porcine root, porcine pericardial) — used in tens of thousands of patients
- Demonstrated to reduce calcium
- Stored in a solution of glutaraldehyde to continuously reduce free aldehydes
No clinical data is available that evaluates the long-term impact of AOA treatment in patients.
Lifetime management
- The geometry and stable hemodynamic performance of Avalus™ enables possible future valve-in-valve (ViV) replacement.
- The base frame contains barium sulfate for radiopacity to facilitate ViV procedures.
- The interior mounted leaflets help mitigate risk of coronary obstruction in ViV procedures.
Heart Valves Surgical portfolio
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Contact usReferences
1
PERIGON Pivotal Trial data on file as of October 2021.
2
Medtronic data on file.
3
Medtronic data on file. This data may not be indicative of clinical performance.
4
Avalus™ Bioprosthesis Instructions For Use. 2017. Medtronic. Based on one-year clinical data from the PERIGON Pivotal Trial for the Avalus™ valve.
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. December 6, 2015;12(113):20150737.
6
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. May 18, 2010;121(19):2123-2129.
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. September 2018;9(3):351-364.
8
Ruzicka DJ, Hettich I, Hutter A, et al. The complete supraannular concept. Circulation. 2009;120[suppl 1]:S139-S145.