Healthcare Professionals

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

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 a complete listing of Indications, Contraindications, Warnings, Precautions and Adverse events, Please refer to the Instructions for Use provided with the product.

 


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.