Tissue valves and conduits

Freestyle™ aortic root bioprosthesis

<p>The Freestyle™ aortic root bioprosthesis emulates the native aortic valve, designed for hemodynamics and durability.</p>

Ordering information

Contact a representative

Indications, Safety, and WarningsIndications for use The Freestyle bioprosthesis is indicated for the replacement of malfunctioning native or prosthetic aortic valves with the option, for Model 995 only, of aortic root replacement. Contraindications None known.Warnings, precautions, and adverse events Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, anticoagulant/antiplatelet-related hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction (pannus, suture, inappropriate sizing, or other), structural deterioration (calcification, leaflet tear, intracuspal hematoma, pseudoaneurysm (Model 995), or other), thromboembolism, valve thrombosis, root dilatation (Model 995), angina, infection other than endocarditis, heart failure, hemolytic anemia, myocardial infarction, acute kidney injury, or renal failure. It is possible that these complications could lead to reoperation, explantation, permanent disability, or death. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (IFU). If applicable, consult electronic IFUs (eIFUs) at www.medtronic.com/manuals. Note: eIFUs can be viewed using a current version of any major internet browser. US-CV-2500585 v1.0

Features

Durability

Published clinical experience demonstrates impressive long-term performance in many age groups.¹ Additional factors that may contribute to durability are:

Proprietary AOA™ anti-calcification tissue treatment designed to reduce calcification and protect the tissue^†
Physiologic fixation process that reduces the stress applied to the leaflets during fixation

† No clinical data is available which evaluates the long-term impact of the physiologic fixation process or the impact of AOA™ treatment in patients.

AOA™ anti-calcification tissue treatment

Stentless design

By closely mimicking human physiology, the Freestyle™ valve offers excellent hemodynamics and long-term durability.

Excellent clinical performance

Very low rates of SVD, including a rate of freedom from explant due to SVD^‡ of 83% at 15 years¹
Single-digit gradients out to 10 years²

‡ Failure of any component of the bioprosthesis causing stenosis or insufficiency. Excluded is endocarditis and/or thrombosed bioprosthetic valve as cause of dysfunction.

Maximum blood flow

The Freestyle™ valve provides industry-leading hemodynamic performance. Studies have shown the Freestyle™ valve, with its stentless design, has significantly better hemodynamic performance than stented or mechanical aortic surgical valves.^3,4 Hemodynamic results with the Freestyle™ valve have shown:

Larger post-operative effective orifice areas (EOA) than stented or mechanical valves³
Stable, single-digit gradients and large EOAs at 10 years¹

This is a CT scan showing the Freestyle™ aortic valve hemodynamics.

Advanced tissue fixation

Our exclusive physiologic fixation process mitigates biomechanical failures and is engineered for long-term valve durability by:

Improving preservation of valve structure and leaflet function, allowing it to function like a native valve
Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue

Surgical valve replacement risks may include infection, surgical complications, stroke, endocarditis, and death.

This is an illustration of the Mosaic™ mitral valve and Freestyle™ aortic valve tissue fixation design with callouts.

Leaflets float at net zero pressure
Roots are pressured at 40 mmHg with glutaraldehyde

Ordering information

Freestyle™ aortic root bioprosthesis

Item number	Valve size (± 0.5 mm)	Outside diameter (+ 0.5–0.0 mm)	Profile height (± 2 mm)	Inner cloth height (± 0.5 mm)
Item number	Valve size (± 0.5 mm)	(A)	(B)	(C)
FR995-19	19	19.0	30	3.0
FR995-21	21	21.0	32	3.0
FR995-23	23	23.0	32	3.0
FR995-25	25	25.0	34	3.0
FR995-27	27	27.0	34	3.0
FR995-29	29	29.0	39 ± 3 mm	3.0