EPICTM PLUS/ EPICTM PLUS SUPRA STENTED PORCINE TISSUE VALVES
INDICATION FOR USE
The Epic™ Plus 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 Epic™ Plus 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, valve damage, diminished tissue durability and/or damage to the surrounding tissues. The use of an inappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the E2000 Epic™ Plus Heart Valve Sizer Set with the Epic™ Plus and Epic™ Plus Supra valves.
- Accelerated deterioration due to calcific degeneration of the Epic Plus and Epic Plus 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 Epic™ Plus and Epic™ Plus 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 or come in direct contact with the aortic wall.
- When implanting the Epic™ Plus heart valve, assess the suitability of the selected valve size and stent post position for a potential future valve-in-valve procedure and whether the transcatheter valve-in-valve procedure may result in left ventricular outflow tract or coronary ostia obstruction. For future valve-in-valve procedure in an Epic Plus valve, refer to the instructions for use supplied with the transcatheter heart valve along with reference dimensions in Table 1 (in the IFU) to determine compatibility. The safety and effectiveness of valve-in-valve procedures in an Epic™ Plus or an Epic™ Plus Supra valve have not been established.
- 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™ Plus valve and the Epic™ Plus 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