The EpicTM Mitral stented tissue valve with LinxTM anticalcification (AC) technology achieves minimal valvular regurgitation by providing two features crucial in the mitral position: impressive paravalvular cuff sealing and central leaflet coaptation.
EpicTM Mitral also features the FlexFitTM 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
EpicTM 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.
|EpicTM Mitral Valve||vs||Magna Mitral EaseTM 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 EpicTM 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 FlexFitTM system is a simple 2-step|
click-in and click-off process
|Holder||Tricentrix is a 7-step implantation process3|
Abbott’s unique LinxTM AC technology—to promote anticalcification* —is designed to improve long-term performance and valve durability. The LinxTM 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
AP2947048-WBU Rev. A
- EpicTM Valve IFU.
- Magna Mitral EaseTM IFU.
- Magna Mitral EaseTM 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.
EPICTM/ EPICTM SUPRA STENTED PORCINE TISSUE VALVES
INDICATION FOR USE
The EpicTM valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve. The EpicTM Supra valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.
- Valve size selection is based on the size of the recipient annulus, and for supra-annular aortic placement, the anatomy of the sinotubular space. Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissues. The use of an inappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the St. Jude MedicalTM Bioprosthetic Heart Valve Sizer Set Model B1000 with the Epic and Epic Supra valves.
- Accelerated deterioration due to calcific degeneration of the Epic and Epic Supra valve may occur in:
- children, adolescents, or young adults;
- patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure); or
- individuals requiring hemodialysis.
- For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
- Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
- Do not use if:
- the valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration;
- the expiration date has elapsed;
- the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging; or
- the storage solution does not completely cover the valve.
- The safety and effectiveness of the EpicTM and EpicTM Supra valves has not been established for the following specific populations:
- patients who are pregnant
- nursing mothers
- patients with chronic renal failure
- patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
- patients with chronic endocarditis
- patients requiring pulmonic or tricuspid valve replacement
- children, adolescents, or young adults
- Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, deformed, or damaged sizer set components.
- Do not pass the flanged portion of the valve replica sizing tool through the annulus.
- Do not place the non-sterile exterior of the valve container in the sterile field.
- Do not expose the valve to solutions other than the formaldehyde valve storage solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline solution used to irrigate the valve.
- Do not add antibiotics to either the formaldehyde valve storage solution or the rinse solution.
- Do not apply antibiotics to the valve.
- Do not allow the valve tissue to dry. Place the valve in sterile isotonic saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
- Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5 °C to 25 °C range.
- Do not implant the valve without thoroughly rinsing as directed.
- Do not lacerate the valve tissue. If a valve is damaged, the valve must be explanted and replaced.
- Do not attempt to repair a valve. Damaged valves must not be used.
- Do not use cutting edge needles, unprotected forceps, or sharp instruments as they may cause structural damage to valve.
- Never handle the leaflet tissue.
- Position the mitral valve in a manner to avoid commissure obstruction of the left ventricular outflow tract, and minimize any potential of commissure contact with the ventricular wall.
- Position the aortic valve so that the stent posts do not obstruct the coronary ostia.
- Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.
The clinical investigation of the Epic valve supports the safety and effectiveness of the Epic valve and the Epic Supra valve. Between January 2003 and March 2006, seven-hundred and sixty-two (762) subjects were implanted with 791 Epic Valve(s) at 19 investigational sites in the United States (U.S.), and three sites in Canada. Five-hundred and fifty-seven (557) subjects received isolated aortic replacement, 176 received isolated mitral replacement, and 29 received replacement of both the aortic and mitral valves. The cumulative follow-up for all subjects was 773.51 patient-years with a mean follow-up of 1.02 patient-years (s.d. = 0.71 patient-years, range 0 – 3.10 patient-years).
Potential Adverse Events
Adverse events potentially associated with the use of bioprosthesis heart valves (in alphabetical order) include:
- cardiac arrhythmias
- heart failure
- hemolytic anemia
- hemorrhage, anticoagulant/antiplatelet-related
- leak, transvalvular or paravalvular
- myocardial infarction
- nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
- prosthesis regurgitation
- structural deterioration (calcification, leaflet tear, or other)
- valve thrombosis
It is possible that these complications could lead to:
- permanent disability