Simplici-T Annuloplasty System
The Simplici-T® Annuloplasty System offers a first-of-its-kind approach to mitral and tricuspid valve repair.
Summary
Repair Redefined
The Simplici-T® System is the first flexible band to eliminate the need for traditional sizing, providing a custom fit for every patient and requiring less inventory space.
Correct annuloplasty band sizing is an important element to achieve a successful repair.
No more sizing – One size is always the right size. The Simplici-T System is based on the “no sizing” implant technique of Dr. Tirone David, one of the world’s most outstanding technical cardiac surgeons.
Customized for every patient – The flexible band adapts to the unique needs of every patient. Implanted band length is determined by the annular size and degree of plication of the annular tissue.
Reduced inventory – The flexible annuloplasty band is supplied in a length of 100 mm and requires no additional accessories.
Offers the benefits of a flexible band, including:
- 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
“I have not sized a mitral valve for an annuloplasty band for more than a decade. Simplici-T allows the surgeon to tailor the length of the band according to the pathology.”
Tirone E. David, M.D.*
Important Safety Information
- 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.
* Tirone E. David receives royalties from Medtronic, Inc. on sales of the Simplici-T annuloplasty system.
References
- David TE, Armstrong S, Sun Z. Left ventricular function after mitral valve surgery. J Heart Dis. 1995;4:S175-80.
- Tsakiris 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
- Ormiston JA, Shah PM, Tei C, et al. Size and motion in the mitral valve annulus in man. Circulation. 1981;64:113.
- Duran 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.
- Okada 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.
- Duran C. Perspectives for acquired valvular disease. Advanced Cardiac Surgery. 1993;Vol. 4.