Surgical Mitral

Pericardial Valves

Surgical Mitral

Pericardial Valves

CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE VALVE

Built upon the unique and proven PERIMOUNT design, the Magna Mitral Ease valve gives you and your patients:
  • Ultra-low profile, with reduced ventricular projection by up to 40%
  • Exceptional long-term durability1-7
  • Ease of implant
The Magna Mitral Ease valve is built upon the proven, time-tested PERIMOUNT valve design, with unique design elements including:
  • Mathematically modeled, bioengineered design. Intended to optimize implantability, hemodynamics and long-term durability
  • Flexible cobalt-chromium alloy stent. Absorbs energy to reduce leaflet stress
  • Three independent bovine pericardial leaflets. Matched for thickness and elasticity to optimize stress distribution


‡ As compared to the Carpentier-Edwards PERIMOUNT Theon mitral valve.

Model 7300TFX

Ease of Implant

  • Wide, contoured cuff with unique anterior saddle and lateral contour to mimic the shape of the native mitral anatomy

Exceptional Long-Term Durability

Model 7300TFX
Ease of Implant
Exceptional Long-Term Durability

Magna Mitral Ease Heart Valve

Model 7300TFX Nominal Specifications (mm)Size 25Size 27Size 29Size 31Size 33
A. Stent Diameter (Wireform) 25 27 29 31 31
B. Tissue Annulus Diameter 28 29.5 31.5 33.5 33.5
C. External Sewing Ring Diameter 36 38 40 42 44
D. Anterior Effective Profile 7 7.5 8 8.5 8.5
Specifications

ModelDescriptionSizesImage
7300TFX Carpentier-Edwards PERIMOUNT
Magna Mitral Ease
pericardial valve
with Carpentier-Edwards
ThermaFix process*
25, 27, 29, 31, & 33 mm Magna Mitral Ease Model 7300TFX

ModelDescriptionCompatible with Valve ModelsSizes
SET1173B Barrel Sizer Accessory Set 7300TFX Includes All
SET1173R Replica Sizer Accessory Set 7300TFX Includes All
1173 Flexible, Reusable Handle 7300TFX N/A
1111 Reusable Handle 6900P, 6900PTFX, 7300TFX N/A
1117 Flexible, Reusable Mitral Handle 6900PTFX, 7300TFX N/A
1126 Longer, Single Use Handle 6900P, 6900PTFX, 7300TFX N/A
Magna Mitral Ease Handle
Flexible, reusable handle
Model 1173

Pre-attached barrel and replica sizers facilitate valve sizing

Magna Mitral Ease Sizer

Barrel sizer accessory set
Model SET11173B

Magna Mitral Ease Replica

Replica sizer accessory set
Model SET1173R



* No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.

References:
  1. Jamieson WRE, et al. Structural Valve Deterioration in Mitral Replacement Surgery: Comparison of Carpentier-Edwards Supra-Annular Porcine and PERIMOUNT Pericardial Bioprostheses. J Thorac Cardiovasc Surg. 1999 Aug;118:297-305. (Freedom from explant due to structural valve deterioration; n = 429; mean age = 60.7 ± 11.7 yrs)
  2. Aupart MR, et al. Carpentier-Edwards pericardial valves in the mitral position: ten-year follow-up. J Thorac Cardiovasc Surg. 1997 Mar;113(3):492-8. (Freedom from structural deterioration; n = 150; mean age = 62.9 ± 11.9 yrs)
  3. Murakami T, et al. Aortic and mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 10-year results. J Heart Valve Dis. 1996 Jan;5(1):45-9. (Freedom from structural deterioration; n = 57; mean age = 55.1 ± 13.2 yrs)
  4. Poirier NC, et al. 15-year experience with the Carpentier-Edwards pericardial bioprosthesis. Ann Thorac Surg. 1998;66:S57-61. (Freedom from structural deterioration; n = 214; mean age = 65 ± 23 yrs)
  5. Neville PH, et al. Carpentier-Edwards pericardial bioprosthesis in aortic or mitral position: a 12-year experience. Ann Thorac Surg. 1998;66(6 Suppl):S143-7. (Freedom from structural deterioration; n = 182; mean age = 63.9 ± 11.5 yrs)
  6. Marchand MA, et al. Fifteen-year experience with the mitral Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. Ann Thorac Surg. 2001 May;71(5 Suppl):S236-9. (Freedom from structural valve deterioration; n = 435; mean age = 60.7 ± 11.6 yrs)
  7. Bourguignon, T, et al. Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25 year follow-up of 450 implantations. J Thorac Cardiovasc Surg. 2014 Nov;148:2004-11. (Freedom from explant due to structural valve deterioration; n = 404; mean age = 68.0 ± 10.4 yrs)
  8. Carpentier-Edwards PERIMOUNT pericardial bioprosthesis 16-year results. Data on file at Edwards Lifesciences, 2003. (Freedom from explant due to structural valve deterioration; n = 435; mean age = 60.7 ± 11.6 yrs)

CARPENTIER-EDWARDS PERIMOUNT THEON VALVE

Designed specifically for the mitral valve position...

Bioengineered PERIMOUNT Design

  • Mathematically modeled bioengineered design is intended to optimize implantability, hemodynamics and long-term durability1-7
  • Flexible cobalt-chromium alloy stent absorbs energy during the cardiac cycle
  • Three independent symmetrical pericardial leaflets matched for thickness and elasticity are mounted under a flexible stent

Mitral Design

  • Black suture markers indicate proper orientation

Implantability

  • The Tricentrix holder system is intended to provide ease of implant
  • When fully deployed, the commissures should deflect towards the center of the valve, helping to guide sutures into their correct position and prevent the formation of suture loops

Tissue Treatment

  • The PERIMOUNT Theon valve is treated with the Carpentier-Edwards ThermaFix process*, confronting both major calcium binding sites: residual glutaraldehydes and phospholipids

* No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.

The Tricentrix holder system is intended to provide ease of implant

The Tricentrix holder system is intended to provide ease of implant

PERIMOUNT Theon Mitral Valve

ModelDescriptionSizesImage
6900PTFX Carpentier-Edwards
PERIMOUNT Theon
mitral pericardial valve
with ThermaFix process*
25, 27, 29, 31, & 33 mm Theon mitral Model 6900PTFX

ModelDescriptionCompatible with Valve ModelsSizes
1169HP or 1169P Sizer - Individual 6900PTFX 25, 27, 29, 31, & 33 mm
TRAY1169HP or TRAY1169 Accessory Tray 6900PTFX N/A
1111 Reusable Handle 6900P, 6900PTFX, 7300TFX N/A
1117 Flexible, Reusable Mitral Handle 6900PTFX, 7300TFX N/A
1126 Longer, Single Use Handle 6900P, 6900PTFX, 7300TFX N/A



* No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.

References:
  1. Aupart MR, et al. Carpentier-Edwards pericardial valves in the mitral position: ten-year follow-up. J Thorac Cardiovasc Surg. 1997 Mar;113(3):492-8. (Freedom from structural deterioration; n = 150; mean age = 62.9 ± 11.9 yrs)
  2. Bourguignon, T, et al. Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25 year follow-up of 450 implantations. J Thorac Cardiovasc Surg. 2014 Nov;148:2004-11. (Freedom from explant due to structural valve deterioration, n=450; mean age=68.0 ± 10.4 yrs)
  3. Jamieson WRE, et al. Structural Valve Deterioration in Mitral Replacement Surgery: Comparison of Carpentier-Edwards Supra-Annular Porcine and PERIMOUNT Pericardial Bioprostheses. J Thorac Cardiovasc Surg. 1999 Aug;118:297-305. (Freedom from explant due to structural valve deterioration; n = 429; mean age = 60.7 ± 11.7 yrs)
  4. Marchand MA, et al. Fifteen-year experience with the mitral Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. Ann Thorac Surg. 2001 May;71(5 Suppl):S236-9. (Freedom from explant due to structural valve deterioration; n = 435; mean age = 60.7 ± 11.6 yrs)
  5. Murakami T, et al. Aortic and mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 10-year results. J Heart Valve Dis. 1996 Jan;5(1):45-9. (Freedom from structural deterioration; n = 57; mean age = 55.1 ± 13.2 yrs)
  6. Neville PH, et al. Carpentier-Edwards pericardial bioprosthesis in aortic or mitral position: a 12-year experience. Ann Thorac Surg. 1998;66(6 Suppl):S143-7. (Freedom from structural deterioration; n = 182; mean age = 63.9 ± 11.5 yrs)
  7. Poirier NC, et al. 15-year experience with the Carpentier-Edwards pericardial bioprosthesis. Ann Thorac Surg. 1998;66:S57-61. (Freedom from structural deterioration; n = 214; mean age = 65 ± 23 yrs)

CARPENTIER-EDWARDS PERIMOUNT PLUS VALVE

Designed specifically for the mitral valve position...

Bioengineered PERIMOUNT Design

  • Mathematically modeled bioengineered design is intended to optimize implantability, hemodynamics and long-term durability1-7
  • Flexible cobalt-chromium alloy stent absorbs energy during the cardiac cycle
  • Three independent symmetrical pericardial leaflets matched for thickness and elasticity are mounted under a flexible stent

Mitral Design

  • Black suture markers indicate proper orientation

Implantability

  • The Tricentrix holder system is intended to provide ease of implant
  • When fully deployed, the commissures should deflect towards the center of the valve, helping to guide sutures into their correct position and prevent the formation of suture loops

Tissue Treatment

  • The PERIMOUNT Plus valve is treated with the XenoLogiX treatment*, a two-step process targeting residual phospholipids

* No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.

Model 6900P

PERIMOUNT Plus Mitral Valve

ModelDescriptionSizesImage
6900P Carpentier-Edwards
PERIMOUNT Plus
mitral pericardial valve
25, 27, 29, 31, & 33 mm Theon Mitral Model 6900PTFX

ModelDescriptionCompatible with Valve ModelsSizes
1169P Sizer - Individual 6900P, 6900PTFX 25, 27, 29, 31, & 33 mm
1111 Reusable Handle 6900P, 6900PTFX, 7300TFX N/A
1126 Longer, Single Use Handle 6900P, 6900PTFX, 7300TFX N/A
References:
  1. Aupart MR, et al. Carpentier-Edwards pericardial valves in the mitral position: ten-year follow-up. J Thorac Cardiovasc Surg. 1997 Mar;113(3):492-8. (Freedom from structural deterioration; n = 150; mean age = 62.9 ± 11.9 yrs)
  2. Bourguignon, T, et al. Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25 year follow-up of 450 implantations. J Thorac Cardiovasc Surg. 2014 Nov;148:2004-11. (Freedom from explant due to structural valve deterioration, n=450; mean age=68.0 ± 10.4 yrs)
  3. Jamieson WRE, et al. Structural Valve Deterioration in Mitral Replacement Surgery: Comparison of Carpentier-Edwards Supra-Annular Porcine and PERIMOUNT Pericardial Bioprostheses. J Thorac Cardiovasc Surg. 1999 Aug;118:297-305. (Freedom from explant due to structural valve deterioration; n = 429; mean age = 60.7 ± 11.7 yrs)
  4. Marchand MA, et al. Fifteen-year experience with the mitral Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. Ann Thorac Surg. 2001 May;71(5 Suppl):S236-9. (Freedom from explant due to structural valve deterioration; n = 435; mean age = 60.7 ± 11.6 yrs)
  5. Murakami T, et al. Aortic and mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 10-year results. J Heart Valve Dis. 1996 Jan;5(1):45-9. (Freedom from structural deterioration; n = 57; mean age = 55.1 ± 13.2 yrs)
  6. Neville PH, et al. Carpentier-Edwards pericardial bioprosthesis in aortic or mitral position: a 12-year experience. Ann Thorac Surg. 1998;66(6 Suppl):S143-7. (Freedom from structural deterioration; n = 182; mean age = 63.9 ± 11.5 yrs)
  7. Poirier NC, et al. 15-year experience with the Carpentier-Edwards pericardial bioprosthesis. Ann Thorac Surg. 1998;66:S57-61. (Freedom from structural deterioration; n = 214; mean age = 65 ± 23 yrs)

Important Safety Information

Brief Summary: MItral Bioprostheses

Indications: For use in patients whose mitral valvular disease warrants replacement of their natural or previously placed prosthetic valve and

Important Safety Information

Brief Summary: Mitral Bioprostheses

Indications: For use in patients whose mitral valvular disease warrants replacement of their natural or previously placed prosthetic valve and when the valve cannot be repaired.

Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests.

Complications and Side Effects: Stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/ stroke, congestive heart failure, myocardial infarction, angina, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability and death.

Warnings: Alternative therapies should be considered in the presence of conditions affecting calcium metabolism or when calcium containing chronic drug therapies are used, including children, adolescents, young adults and patients on a high calcium diet or maintenance hemodialysis. Should be used with caution in the presence of severe systemic hypertension or when anticipated patient longevity is longer than the known longevity of the prosthesis.

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

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