Products and Solutions

EPIC^TM/ EPIC^TM SUPRA STENTED PORCINE TISSUE VALVES
INDICATION FOR USE

The Epic^TM 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^TM 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.

CONTRAINDICATIONS

None known.

WARNINGS

• 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 Medical^TM 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.

PRECAUTIONS

• The safety and effectiveness of the Epic^TM and Epic^TM 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.

ADVERSE EVENTS

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: 

• angina
• cardiac arrhythmias
• endocarditis
• heart failure
• hemolysis
• 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
• stroke
• structural deterioration (calcification, leaflet tear, or other)
•  thromboembolism
•  valve thrombosis

It is possible that these complications could lead to:

•  reoperation
•  explantation
•  permanent disability
•  death

TRIFECTA^TM VALVE WITH GLIDE^TM TECHNOLOGY (GT)
INDICATION FOR USE

The Trifecta^TM Valve with Glide^TM Technology is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.

CONTRAINDICATIONS

None known.

WARNINGS

• For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
• Do not oversize. Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. If the native annulus measurement falls between the two valve sizes, use the smaller size valve. Use only the Model TF2000 Trifect^TM Sizers for sizing the valve. Implantation of an oversized valve may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability, and/or damage to the surrounding tissues.
• Passage of a diagnostic catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
• Accelerated deterioration of the valve may occur in:
  • Children, adolescents, or young adults
  • Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
  • Individuals requiring hemodialysis
• 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 jar seal is damaged, broken, or missing or if fluid is leaking from the packaging.
  • The storage solution does not completely cover the valve.
• Use only the Trifecta^TM Model TF2000 sizers1 for sizing the valve.
• The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair valve function.

PRECAUTIONS

• Safety and effectiveness of the valve 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
• Sizer sets are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizer set components.
• Do not place the non-sterile exterior of the valve jar in the sterile field.
• 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–25°C (41°F–77°F) range.
• Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped,  the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline  used to irrigate the valve.
• Do not add antibiotics to either the 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 isotonic sterile 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 implant the valve without thoroughly rinsing as directed.
• Position the valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
• Never handle the leaflet tissue.
• 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.
• Use caution when placing sutures through the  sewing cuff to void lacerating the valve tissue.  If a valve is damaged, the valve must be replaced.
• Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
• Do not attempt to repair a valve. Damaged valves must not be used.
• Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
• Use caution when tying knots to avoid bending  the stent posts.

ADVERSE EVENTS

The Trifecta^TM Valve with Glide^TM Technology is based upon the Trifecta^TM Valve design. Therefore, a previous clinical investigation of the Trifecta^TM Valve supports the safety of the Trifecta^TM Valve with Glide^TM Technology. Between June 2007 and November 2009, one thousand and twenty-two (1022) subjects were implanted with the Trifecta valve in the aortic position at 31 investigational sites in the United States (18), Canada (7), and Europe (6). Data are presented on the one thousand and fourteen (1014) subjects who met eligibility criteria. The cumulative follow-up for all subjects was 924.18 patient-years with a mean follow-up of 0.91 years (SD = 0.49 years, range 0 - 2.38 years).

Adverse events potentially associated with the use of bioprosthetic heart valves include:

• angina
• cardiac arrhythmias
• endocarditis
• heart failure
• hemolysis
• hemolytic anemia 
• hemorrhage
• leak, transvalvular or paravalvular
• myocardial infarction
• nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
• prosthesis regurgitation
• stroke
• structural deterioration (calcification, leaflet tear, or other)
• thromboembolism
• valve thrombosis

It is possible that these complications could lead to:

• reoperation
• explantation
• permanent disability
• death

See the Clinical Study section of these instructions for adverse event data collected in the Trifecta^TM Valve clinical investigation.

1. TF2000 sizers are included in sizer set models TF2000 and TF2000-2.

SJM REGENT^TM MECHANICAL HEART VALVE
INDICATION FOR USE

The SJM Regent^TM Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted aortic prosthetic heart valve.

CONTRAINDICATIONS

The SJM Regent^TM Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

WARNINGS

• For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
• Do not use if:
  • The valve has been dropped, damaged, or mishandled in any way.
  • The expiration date has elapsed.
  • The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
• Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
• Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM Regent^TM Mechanical Heart Valve sizes, use the smaller size SJM Regent^TM Mechanical Heart Valve.
• Use only St. Jude Medical^TM mechanical heart valve sizers.
• The outer tray is not sterile, and should not be placed in the sterile field.
• To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
• Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude Medical^TM leaflet tester to gently test valve leaflet mobility.
• Do not use cutting edge needles in the sewing cuff. If use of these needles is necessary, placement of sutures in the outer half of the sewing cuff is imperative.
• Never apply force to the valve leaflets. Force may cause structural damage to the valve.
• Use only the valve holder/rotator packaged with the SJM Regent^TM Mechanical Heart Valve to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/ rotator is intended for single use only and should be discarded after surgery.
• The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM Regent^TM Mechanical Heart Valve can be rotated.
• Do not pass catheters or other instruments through St. Jude Medical^TM mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
• Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.

PRECAUTIONS

• Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
• Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM Regent^TM Mechanical Heart Valve.
• Before placing sutures in the valve cuff, verify that the valve is mounted correctly on the valve holder/rotator.
• To avoid structural damage, the valve must be rotated in the fully closed position.
• To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
• Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

POTENTIAL ADVERSE EVENTS

Complications associated with replacement mechanical heart valves include, but are not limited to:

hemolysis; infections; thrombus; or thromboembolism; valve dehiscence; unacceptable hemodynamic performance; hemorrhagic complications secondary to anticoagulation therapy; prosthetic failure; and heart failure or death.

Any of these complications may require reoperation or explantation of the device.