Carpentier-Edwards PERIMOUNT THEON Pericardial Bioprostheses

CARPENTIER-EDWARDS
PERIMOUNT THEON
PERICARDIAL BIOPROSTHESES
ECLIPSING PERFORMANCE

CARPENTIER-EDWARDS
PERIMOUNT THEON
PERICARDIAL BIOPROSTHESES
Putting performance out front
Carpentier-Edwards PERIMOUNT THEON pericardial bioprostheses balance ease of implantation
with a 20-year PERIMOUNT tissue valve legacy of proven long-term durability. Now, by adding
the Carpentier-Edwards ThermaFix process * —the only tissue treatment to confront both major
causes of calcification—PERIMOUNT THEON pericardial bioprostheses put long-term performance
and confidence in a whole new light. 1,2
The ThermaFix process
Untreated leaflet tissue.
Treated with the ThermaFix process.
Lasting
Performance
Longevity
The PERIMOUNT platform
track record of uncomprom
mitral position. 5
Mechanism of dual-action performance
1: Residual glutaraldehyde subtraction.
2: Phospholipid extraction.
Dual-Action
Performance
The Carpentier-Edwards ThermaFix
Current science indicates that confronting
phospholipids and glutaraldehyde residual
necessary to mitigate the effects of SVD. 1

Streamlined
Performance
Proven
Performance
Implantability
Designed for ease of use, PERIMOUNT THEON bioprostheses provide
exceptional annular conformity, accessible suturing areas, low profiles,
and efficient deliverability to challenging anatomy. 3
Hemodynamics
PERIMOUNT THEON bioprostheses are supported by 17 years of proven hemodynamic stability, 6
as well as industry-leading performance data on EOAs and transvalvular gradients. 3,7
of pericardial tissue valves delivers robust performance with a proven
ised durability up to 20 years in the aortic position 4 and 16 years in the
process *
the two potential calcium binding sites in bioprosthetic tissue —
s 2 —is critical to achieving the long-term structural integrity
The ThermaFix process is the
only dual-action tissue treatment
that confronts both major
calcium binding sites and only
PERIMOUNT valves have the
ThermaFix process. 3

Magenta keyline does not print. Indicates pocket.
Carpentier-Edwards PERIMOUNT THEON Pericardial Bioprostheses
Aortic nominal specifications (mm) Model 2700TFX Model 2800TFX (RSR) †
B
A
D
C
Size 19 mm 21mm 23 mm 25 mm 27mm 29 mm 19 mm 21mm 23 mm 25 mm 27mm 29 mm
A. Mounting Diameter (Annulus) 19 21 23 25 27 29 19 21 23 25 27 29
B. Internal Diameter (Stent I.D.) 18 20 22 24 26 28 18 20 22 24 26 28
C. Profile Height 13 14 15 16 17 18 14 15 16 17 18 19
D. External Sewing Ring Diameter 28 31 33 35 38 40 26 28 31 32 35 37
Note: Valve size is denoted by Dimension A, Mounting Diameter (Annulus)
†Reduced sewing ring
Mitral nominal specifications (mm) model 6900PTFX
Size 25 mm 27mm 29 mm 31 mm 33 mm
A. Stent Diameter (Wireform) 25 27 29 31 31
B. External Stent Post Diameter (Base) 28.0 29.5 31.5 33.5 33.5
C. External Stent Post Diameter (Tip) 29 31 34 35 35
D. External Sewing Ring Diameter 34 36 39 41 43
E. Ventricular Projection 12 13 14 14 15
F. Total Profile Height 17 18 19 20 20
Aortic accessories
• Sizer model 1127 available in sizes 19-29 mm
(for use with 2700TFX).
• Sizer model 1161 available in sizes 19-29 mm
(for use with 2800TFX).
• Reusable handle, model 1111.
Mitral accessories
• Edwards Tricentrix holder system.
• Flexible mitral handle, model 1117.
• Performance-based sizers with EOA identification,
model 1169HP.
• Longer reusable handle, model 1117.
• Longer single-use handle, model 1126.
*No clinical data are available which evaluate the long-term impact of the Edwards Lifesciences tissue treatment in patients.
References
1. Schoen FJ, Levy RJ. Calcification of tissue heart valve substitutes: Progress toward understanding and prevention.
Ann Thorac Surg 2005;79: 1072-80.
2. Data on file. Edwards Lifesciences. RD 127, RD 128, RD 784, RD 795.
3. Carpentier-Edwards PERIMOUNT Theon pericardial bioprostheses, models 2700TFX, 2800TFX, and 6900PTFX product inserts–
Directions for use–2006. 2007.
4. Carpentier-Edwards PERIMOUNT aortic pericardial bioprosthesis 20-year Results. Data on file at Edwards Lifesciences, 2003.
5. Carpentier-Edwards PERIMOUNT mitral pericardial bioprosthesis 16-year Results. Data on file at Edwards Lifesciences, 2003.
6. Banbury, et al. Hemodynamic stability during 17 years of the Carpentier-Edwards aortic pericardial bioprosthesis.
Ann Thorac Surg 2002; 73: 1460-5.
7. Dalmau, et al. The Carpentier-Edwards Perimount Magna aortic xenograft: a new design with an improved hemodynamic performance.
Interactive Card and Thorac Surg 5 2006; 263-267.
Rx only. See instructions for use for full prescribing information.
Edwards, PERIMOUNT THEON and ThermaFix are trademarks
of Edwards Lifesciences Corporation. Edwards Lifesciences, the
stylized E logo, Carpentier-Edwards, PERIMOUNT and Tricentrix
are trademarks of Edwards Lifesciences Corporation and are
registered in the United States Patent and Trademark Office.
© 2007 Edwards Lifesciences LLC.
All rights reserved. AR02235
Edwards Lifesciences LLC • One Edwards Way • Irvine, CA 92614 USA • 949.250.2500 • 800.424.3278 • www.edwards.com