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Surgical mitral pericardial valves

mitral pericardial
mitral pericardial
mitral pericardial
mitral valve
mitral valve
mitral valve

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.

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Model 7300TFX

perimount mitral
perimount mitral
perimount mitral

Ease of Implant

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

Ease of Implant
Ease of Implant
Ease of Implant

Exceptional long-term durability

Exceptional long-term durability
Exceptional long-term durability
Exceptional long-term durability
perimount mitral
perimount mitral
perimount mitral
Ease of Implant
Ease of Implant
Ease of Implant
Exceptional long-term durability
Exceptional long-term durability
Exceptional long-term durability

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

Magna Mitral Ease heart valve

Model 7300TFX Nominal Specifications (mm)Size 25Size 27Size 29Size 31Size 33
A. Stent Diameter (Wireform)2527293131
B. Tissue Annulus Diameter2829.531.533.533.5
C. External Sewing Ring Diameter3638404244
D. Anterior Effective Profile77.588.58.5
model 7300FTX
model 7300FTX
model 7300FTX

* 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...

flexible cobalt-chromium stent
flexible cobalt-chromium stent
flexible cobalt-chromium stent

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
black suture markers
black suture markers
black suture markers

Mitral design

  • Black suture markers indicate proper orientation
tricentrix holder
tricentrix holder
tricentrix holder

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

Tricentrix holder
Tricentrix holder
Tricentrix holder

PERIMOUNT Theon mitral valve

Models

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

Accessories

ModelDescriptionCompatible with Valve ModelsSizes
1169HP or 1169PSizer - Individual6900PTFX25, 27, 29, 31, & 33 mm
TRAY1169HP or TRAY1169Accessory Tray6900PTFXN/A
1111Reusable Handle6900P, 6900PTFX, 7300TFXN/A
1117Flexible, Reusable Mitral Handle6900PTFX, 7300TFXN/A
1126Longer, Single Use Handle6900P, 6900PTFX, 7300TFXN/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...

flexible cobalt-chromium stent
flexible cobalt-chromium stent
flexible cobalt-chromium stent

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
black suture markers
black suture markers
black suture markers

Mitral design

  • Black suture markers indicate proper orientation
tricentrix holder
tricentrix holder
tricentrix holder

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

Model 6900P
Model 6900P
Model 6900P

PERIMOUNT Plus mitral valve

Models

ModelDescriptionSizesImage

6900P


Carpentier-Edwards PERIMOUNT Plus mitral pericardial valve25, 27, 29, 31, & 33 mm

Accessories

ModelDescriptionCompatible with Valve ModelsSizes
1169PSizer - Individual6900P, 6900PTFX25, 27, 29, 31, & 33 mm
1111Reusable Handle6900P, 6900PTFX, 7300TFXN/A
1126Longer, Single Use Handle6900P, 6900PTFX, 7300TFXN/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

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.