The Epic™ Mitral stented tissue valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native mitral heart valve. It may also be used to replace a previously implanted prosthetic mitral valve.
The Epic™ Supra stented tissue valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used to replace a previously implanted prosthetic aortic valve.
- Valve durability
- The valve’s expected hemodynamic performance
A bioprosthetic mitral or aortic valve may be a recommended option for patients under the following treatment guidelines1:
- Patients with a contraindication for anticoagulation therapy or an anticipated nonadherence or inability to regulate vitamin K antagonists
- Patients over 70 years of age
- For patients 50-70 years of age, there is no clear consensus on choosing a mechanical vs a tissue valve; newer-generation tissue prostheses may show greater freedom from structural deterioration, often for older patients
MITRAL valve replacement
- Chronic, severe mitral regurgitation (MR) patients undergoing cardiac surgery for other indications1
- Symptomatic patients with chronic, severe MR and left ventricular ejection fraction (LVEF) > 30%2
- Asymptomatic patients with chronic, severe MR and LV dysfunction (LVESD ≥ 45 mm and/or LVEF ≤ 60%)2
- Advanced endocarditis3
Aortic valve replacement
- Severe aortic stenosis (AS) patients undergoing coronary bypass or surgery of the ascending aorta or of another valve2
- Symptomatic patients with severe, high-gradient AS (mean gradient ≥ 40 mm Hg or peak velocity ≥ 4.0 m/s) and low surgical risk2
- Symptomatic patients with severe low-flow, low-gradient (< 40 mm Hg) AS with reduced ejection fraction and evidence of flow (contractile) reserve excluding pseudosevere AS and low surgical risk2
- Asymptomatic patients with severe AS and systolic LV dysfunction (LVEF < 50%) not due to another cause and low surgical risk2
MAT-2006197 v2.0 | Item approved for Global OUS use only.
- Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2017;135(25):e1159-e1195.
- Baumgartner H, Falk V, Bax JJ et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease: The Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2017;38(21):2739-2791.
- Mick SL, Keshavamurthy S, and Gillinov AM. Mitral valve repair vs replacement for the management of valvular heart disease. Eur Heart J. 2017;38:2739-2791.