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Simplici-T

Annuloplasty System

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

1

David TE, Armstrong S, Sun Z. Left ventricular function after mitral valve surgery. J Heart Dis. 1995;4:S175-80.

2

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

3

Ormiston JA, Shah PM, Tei C, et al. Size and motion in the mitral valve annulus in man. Circulation. 1981;64:113.

4

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.

5

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.

6

Duran C. Perspectives for acquired valvular disease. Advanced Cardiac Surgery. 1993;Vol. 4.