Simplici-T

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
  cycle^2-4
• 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.