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Medtronic Simplici-T® Annuloplasty System
MEDTRONIC, INC.
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710 Medtronic Parkway |
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SIMPLICI-T® Annuloplasty System
Designed to eliminate traditional mitral and tricuspid valve sizing
The Simplici-T® Annuloplasty System is the first flexible band to eliminate the need for traditional sizing of mitral and tricuspid valves while providing a custom fit for every patient. The flexible band and holder design allow the surgeon to tailor the length of the band according to the pathology so one size is always the right size.
PDF Documents
Simplici-T® Annuloplasty System In-Service Guide
Video Clips
Simplici-T Annuloplasty System Surgical Video
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Realmedia file
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PRODUCT FEATURES
- No more sizing
- Flexible band and holder adapts to the unique needs of every patient
- Flexible annuloplasty band is supplied in a length of 100mm and requires no additional accessories
- Better early postoperative LV systolic function over patients with a rigid ring1
- Allows annulus size and configuration to adapt to changes throughout cardiac cycle2-4
- Better diastolic blood flow across the mitral valve, particularly during exercise5
- Flexible annuloplasty repair devices place less stress on the sutures during systole, minimizing the likelihood of dehiscence6
Flexible Band Benefits
Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.
Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.
Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, band dehiscence, hemolysis, stenosis, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage, uncorrected or recurrent regurgitation, low cardiac output, thrombosis, damage to coronary arteries. For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
REFERENCES
1David TE, Armstrong S, Sun Z. Left Ventricular Function After Mitral Valve Surgery. J Heart Dis. 1995;4:S175-80.
2Tsakiris AG, Von Vernuth G, Rastilli GC, et al. Size and Motion of the Mitral Valve in Anesthetized Intact Dogs. J Appl Phys. 1971;30:611.
3Ormiston JA, Shah PM, Tei C, et al. Size and Motion in the Mitral Valve Annulus in Man. Circulation. 1981;64:113.
4Duran CMG, Ubago JLM. Clinical and Hemodynamic Performance of a Totally Flexible Prosthetic Ring for Atrio-Ventricular Valve Reconstruction. Ann Thorac Surg. 1976;22:458-63.
5Okada Y, Shomura T, Yamaura YI, et al. Comparison of the Carpentier and Duran Prosthetic Rings Used in Mitral Reconstruction. Ann Thorac Surg. 1995;59:658-63.
6Duran C. Perspectives for Acquired Valvular Disease. In: Advanced Cardiac Surgery, Vol. 4, 1993.
Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.
Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, band dehiscence, hemolysis, stenosis, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage, uncorrected or recurrent regurgitation, low cardiac output, thrombosis, damage to coronary arteries. For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
REFERENCES
1David TE, Armstrong S, Sun Z. Left Ventricular Function After Mitral Valve Surgery. J Heart Dis. 1995;4:S175-80.
2Tsakiris AG, Von Vernuth G, Rastilli GC, et al. Size and Motion of the Mitral Valve in Anesthetized Intact Dogs. J Appl Phys. 1971;30:611.
3Ormiston JA, Shah PM, Tei C, et al. Size and Motion in the Mitral Valve Annulus in Man. Circulation. 1981;64:113.
4Duran CMG, Ubago JLM. Clinical and Hemodynamic Performance of a Totally Flexible Prosthetic Ring for Atrio-Ventricular Valve Reconstruction. Ann Thorac Surg. 1976;22:458-63.
5Okada Y, Shomura T, Yamaura YI, et al. Comparison of the Carpentier and Duran Prosthetic Rings Used in Mitral Reconstruction. Ann Thorac Surg. 1995;59:658-63.
6Duran C. Perspectives for Acquired Valvular Disease. In: Advanced Cardiac Surgery, Vol. 4, 1993.