The Epic Mitral stented tissue valve with Linx anticalcification (AC) technology achieves minimal valvular regurgitation by providing two features crucial in the mitral position: impressive paravalvular cuff sealing and central leaflet coaptation.
Epic Mitral also features the FlexFit system, which helps facilitate the implant process.
The FlexFit system includes:
- Ratcheting system that allows reduction of valve profile
- Flexible polymer stent that can be ratcheted for lower profile and facilitates lower tissue stress during normal valve function
- Click-in holder that allows the holder to be removed while maintaining the lower ratcheted valve profile
- Flexible valve sizers
- 2 x 10 second valve rinse time
The valve’s triple composite design uses three separate porcine leaflets to optimize leaflet coaptation, reduce stress, and mitigate regurgitation. The conformable sewing cuff further minimizes regurgitation in high-risk anatomies, such as a calcified mitral annulus.
- SOFT SEWING CUFF
Provides limited suture drag and parachuting forces
- SYMMETRICAL TRIPLE COMPOSITE DESIGN
Eliminates Septal muscle bar leaflet and the need for orientation which optimizes leaflet coaptation and reduces leaflet stress
- UNIQUE PERICARDIAL SHIELD
Provides a tissue-to-tissue interface to help prevent the risk of abrasion
- Flexible Polymer Stent
Reduces valve overall profile for better maneuverability during implantation
- Ratcheting Holder
Mitigates the potential for suture looping
The Epic Mitral valve has been designed not only for easy implantability, but to allow surgeons to customize their implant techniques based upon patient needs—which can minimize implant-related complications.
|Epic Mitral Valve||vs||Magna Mitral Ease Valve|
|Lowest overall ventricular protrusion in all|
valve sizes, with all 3 stent posts the same height1
|Profile||Asymmetrical design results in the posterior|
strut protruding farther into the ventricle than Epic in all sizes2
|Designed with a flexible polyester cuff1 that|
provides limited suture drag and needle
|Cuff||Rigid silicone sewing ring is covered by|
polytetrafluoroethylene (PTFE) cloth2
|Symmetrical valve design provides flexibility in|
valve placement during implantation
|Shape||Asymmetrical sewing band|
is designed for a specific orientation2
|Valve sizes, which are based on the|
measurement of the tissue annulus,1 ensure
|Sizing||Valve sizes are based on the measurement of the stent diameter2|
|Polymer stent deflects when ratcheted, aiding|
implantability during minimally invasive
surgery and reducing the risk of suture looping
|Stent||Designed with a metallic stent; physicians|
must exercise care to prevent folding or
deformation of the stent2
|Ergonomic FlexFit system is a simple 2-step|
click-in and click-off process
|Holder||Tricentrix is a 7-step implantation process3|
Abbott’s unique Linx AC technology—to promote anticalcification* —is designed to improve long-term performance and valve durability. The Linx AC treatment has demonstrated resistance to calcification by:
- Extracting lipids4
- Reducing free aldehydes5,6
- Minimizing cholesterol uptake7
- Stabilizing leaflet collagen7
*No clinical data currently available have evaluated the long-term impact of anticalcification tissue treatment in humans
AP2947047-WBO Rev. A
- Epic Valve IFU.
- Magna Mitral Ease IFU.
- Magna Mitral Ease Heart Valve Implantation Guide. www.edwards.com/eu/products/heartvalves/Pages/mmeguideppt.aspx. Accessed August 23, 2018.
- Vyavahare, N, Hirsch, D, Lerner, E, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation. Circulation. 1997:95;479-488. doi.org/10.1161/01.CIR.95.2.479.
- Kelly SJ, Ogle MF, Carlyle WC, et al. Biocompatibility and calcification of bioprosthetic heart valves. Presented at: Society for Biomaterials, Sixth World Biomaterials Congress Transaction. May 2000:1353.
- Frater RWM, Seifter E, Liao K, et al. Chapter 8. In: Gabbay, S, Wheatley DJ, eds. Advances in Anticalcific and Antidegenerative Treatment of Heart Valve Bioprostheses. 1st ed. Austin: Silent Partners, Inc; 1997:105-113.
- Vyavahare NR, Hirsch D, Lerner E, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation: mechanistic studies of protein structure and water-biomaterial relationships. J Biomed Mater Res. 1998;40:577-585.