Carpentier-Edwards PERIMOUNT Theon Mitral Replacement System


	Pericardial Heart Valves

Magna Ease Aortic Valve

Magna Mitral Ease Valve

Magna Aortic Valve

Theon Mitral System

Related Products

Why Compromise with Lifelong Anticoagulation

For Patients

Request Information

Technical Information

Heart Valve News

Report from NPR

2006 ACC / AHA Guidelines

Reimbursement

Carpentier-Edwards PERIMOUNT Theon
Mitral Replacement System

The integrated PERIMOUNT Theon mitral replacement system is designed to answer the specific challenges of mitral heart valve replacement, facilitate the implantation process, and maximize clinical outcomes for both surgeon and patient.⁷
Built to last

The actuarial freedom from explant due to SVD is 89% at 16 years¹ in patients 60 and over.
New Carpentier-Edwards ThermaFix^† advanced tissue process extracts both major calcium binding sites³ and is not a reversible binding like other tissue treatments.⁴

Made for mitral

Designed for the mitral heart valve position,⁵ not just an aortic pig valve turned upside down.⁶
Designed by computer generated leaflet sizing according to the stent size, so the commissural stress is minimal.

Designed for surgeons

Specific mitral handle.
Performance-based sizing.
Improved Edwards Tricentrix holder system.
Flexible waffled silicone sewing band.

For patients

No need for lifelong anticoagulation,* widening lifestyle choices and therapeutic options to treat comorbidities.⁸
Slow mode of failure allows for clinical detection—and in many cases an elective low-risk reoperation.^9,10
Excellent hemodynamics benefits all patients.¹¹

^†No clinical data are available which evaluates the long-term impact of Edwards Lifesciences tissue treatments in patients.
*For patients who do not require warfarin for other risk factors and after 3-month usual postoperative period.²

References
1. Carpentier-Edwards PERIMOUNT mitral pericardial bioprosthesis 16-year Results. Data on file at Edwards Lifesciences, 2003.
2. Bonow et al., AHA/ACC Guidelines. J Am Coll Cardiol 98;32:1486-588.
3. Data on file at Edwards Lifesciences RD 784, RD 795, RD 597, RD 127, and RD 128.
4. Chen W, et al. Mechanism of efficacy of 2-amino oleic acid for inhibition of calcification of glutaraldehyde-protreated porcine bioprosthetic heart valves. Circulation 1994;90(1):323-9.
5. Design history files – Data on file at Edwards Lifesciences.
6. Swine as Models in Biomedical Research. Swindle MM, editor. Iowa State University Press, Ames, Iowa 1992.
7. Carpentier-Edwards PERIMOUNT Theon mitral replacement system – Product insert.
8. Coumadin Product Insert - 6672-01/Rev June 2002.
9. Jamieson WR, et al. Reoperation for bioprosthetic mitral structural failure: risk assessment. Circulation 2003;108[suppl II]:II-98-102.
10. Jones TM, et al. Repeat heart valve surgery: Risk factors for operative mortality. J Thorac Cardiovasc Surg 2001;122:913-8.
11. Gudbjartsson T, Aranki S, Cohn LH. Mechanical/Bioprosthetic Mitral Valve Replacement.
In: Cohn LH, Edmunds LH Jr, eds. Cardiac Surgery in the Adult. New York: McGraw-Hill, 2003:951986. Chapter 38

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.

Brochures

Models

Accessories

Implantation Video

Tissue or Mechanical?
DM Cosgrove vs TE David

Clinical Communique

ThermaFix Process

Thought Leaders

Presentations, Educational

Exposure Technique

Prolapse & Aneurysm
Alain Carpentier MD, PHD

Echo Case Studies

Atrial Fibrillation

Important Risk Information