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    •  Avalus™
    bioprosthesis


     Avalus Ultra™
    bioprosthesis

    Surgical valve performance, proven by clinical evidence

    The Avalus Ultra™ bioprosthesis, our most advanced surgical valve, builds on the 12 years of clinical experience of the Avalus™ bioprosthesis. The Avalus™ platform delivers innovative technology backed by robust, real-world clinical evidence.

    Clinical results that matter

    The Avalus™ platform is supported by the largest prospective study of any modern stented surgical valve — the PERIGON Pivotal trial — which followed 1,132 Avalus™ valve patients.1

    The seven-year results provide and demonstrate robust evidence and a proven record of hemodynamic performance and durability.

    • 99% freedom from structural valve deterioration (SVD) and severe hemodynamic dysfunction (SHD) requiring reintervention1
    • 97% freedom from valve-related mortality1
    • 94% freedom from all reintervention1
    • 83% freedom from all-cause mortality1
    See the 7-year results (open in new window)

    Real-world evidence with the ACE registry

    The ACE registry, led by UZ Leuven under the guidance of Prof. Bart Meuris and Prof. Tom Verbelen, gathers prospective, multicenter data from more than 25 leading western European centers and includes 1,250 Avalus™ valve patients. This comprehensive dataset delivers robust insights into the Avalus™ valve’s performance and safety across a wide range of patient populations.​

    ​The ACE registry’s real-world findings confirm the excellent results demonstrated in the PERIGON clinical trial,1 helping ensure every clinical decision is based on what matters most — outstanding patient outcomes.​2

    Review the real-world evidence (open in new window)

    The ultimate valve performance evaluation tool

    Discover the largest dataset of contemporary surgical aortic valves analyzed by a single core lab. Using this dataset, Medtronic created a tool for cardiac surgeons that is a novel, robust instrument for evaluating valve performance.3

    View the dataset and tool (open in new window)

    More than 30 years of clinical use with the AOA™ tissue treatment

    Our trusted AOA™ anti-calcification tissue treatment uses amino oleic acid to help drive durable valve replacements and lifetime patient management.

    This treatment is used across a suite of Medtronic bovine pericardial, porcine root, and porcine pericardial valves used in over half a million patients and counting.†

    View treatment (open in new window)

    † 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.

    Engineered for exceptional valve performance

    Developed to stay true to its form — and your expectations

    When it comes to aortic valve performance, circularity is critical for seamless hemodynamics and long-term durability. Deformation can compromise performance. Unlike competitors, the Avalus™ and Avalus Ultra™ valves are uniquely engineered with a deformation-resistant polyetheretherketone (PEEK) base frame and stent posts designed for a durable, circular foundation to maintain shape and deliver consistent, reliable outcomes for your patients.1,4–9

    Don’t settle for small EOAs.

    The Avalus™ platform has industry-leading EOAs with 2.0 cm2 at seven years in patients with either a bicuspid or tricuspid native valve.1

    The PERIGON Pivotal trial

    n = 1,132, with 576 patients in the long-term follow-up cohort

    Designed for whatever the future holds

    The Avalus™ platform has the largest internal diameter for aortic tissue stented valves in its class to date.10

    Research by Ebels et al., a physician-led study, confirms that the Avalus™ platform has as large as a 3.8 mm advantage in internal flow diameter in valve sizes labeled 23–29 mm over other surgical valves.4,10,11

    This makes our most advanced valve, the Avalus Ultra™ bioprosthesis, an excellent solution with the largest circular foundation and deformation-resistant base frame for future TAV-in-SAV.10

    Explore more (open in new window)
    Labeled diameter Edward Inspiris™* valve Edwards Perimount™* and Magna Ease™* valve Medtronic
    Avalus™ valve
    Inlet orifice diameter (mm)
    19 17.7 17.6 17.8
    21 19.6 19.6 19.8
    23 21.6 21.6 21.8
    25 23.4 23.4 23.8
    27 25.4 25.3 25.8
    29 27.3 27.1 27.8
    Outlet orifice diameter (mm)
    19 15.9 15.3 18.1
    21 18.4 18.4 19.7
    23 19.5 19.5 21.9
    25 20.9 21.5 24.4
    27 22.1 22.8 25.9
    29 25.4 24.5 28.2

    Lifetime patient management

    A valve designed for all SAVR patients

    The PERIGON Pivotal trial included an analysis of patients who had a reintervention (surgical or percutaneous) stratified by age (≤ 65 versus > 65 years) and by cause.

    The trial included 277 patients age 65 or younger and found similar rates of clinical events such as valve thrombosis, paravalvular leak, endocarditis, nonstructural valve dysfunction, or SVD/SHD requiring reintervention in younger and older patients.1
     

    ‡ There were no adjudicated cases of SVD requiring or not requiring reintervention.

    Event All
    (n = 1,132)    		 Age ≤ 65 years
    (n = 277)    		 Age > 65 years
    (n = 855)    		 Log rank
    P value
    Reintervention (all) 5.7 (4.3–7.7) (47) 7.4 (4.5–12.3) (15) 5.1 (3.5–7.3) (32) 0.355
    Value thrombosis 0.2 (0.1–0.8) (2) 0.4 (0.1–2.8) (1) 0.1 (0.0–1.0) (1) 0.417
    Paravalvular leak (all) 0.2 (0.1–0.7) (2) 0.4 (0.1–2.5) (1) 0.1 (0.0–0.9) (1) 0.496
          Major 0.2 (0.1–0.7) (2) 0.4 (0.1–2.5) (1) 0.1 (0.0–0.9) (1) 0.406
    Endocarditis 3.8 (2.7–5.4) (33) 4.4 (2.3–8.5) (9) 3.5 (2.3–5.3) (24) 0.831
    Non-structural valve dysfunction 0.3 (0.1–0.9) (3) 0.7 (0.2–2.9) (2) 0.1 (0.0–0.9) (1) 0.092
    SVD/SHD requiring reintervention           1.2 (0.5–2.5) (7) 1.3 (0.3–5.5) (2) 1.1 (0.4–2.8) (5) 0.957
          SHD requiring reintervention 1.2 (0.5–2.5) (7) 1.3 (0.3–5.5) (2) 1.1 (0.4–2.8) (5) 0.957
          SVD requiring reintervention‡ 7.4 (4.5–12.3) (15) 0.0 (0.0–0.0) (0.0) 0.0 (0.0–0.0) (0.0) N/A

    Fit for future TAV-in-SAV

    With the Avalus Ultra™ valve, experience visibility like never before. The platinum-iridium coil and tantalum badge are designed to sit at the annulus of the valve to assist possible TAV-in-SAV reinterventions.

    The Avalus Ultra™ valve with the Evolut™ FX+ valve in the TAV-in-SAV position

    Fluoroscopic imaging with a phantom sheet

    X-ray imaging without a phantom sheet

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