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Tri-Ad™ 2.0 Adams annuloplasty band shown from the side

Indications, Safety, and WarningsIndicationsThe Tri-Ad™ 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus. Contraindications Severe, generalized, or localized bacterial endocarditis; heavily calcified valves; greatly dilated annulus (not reducible by standard techniques); severe valvular dysfunction (not correctable by standard techniques); valvular retraction with severely reduced mobility; congenital malformations with lack of valvular tissue. Warnings, precautions, and adverse eventsOnly physicians who have received proper training in valve repair should use this device. Adverse events can include uncorrected or recurrent regurgitation, stenosis, band dehiscence, hemolysis (even with mild regurgitation), low cardiac output, heart block, damage to coronary arteries, endocarditis, thrombosis, thromboembolism, anticoagulant-related hemorrhage, band fracture, leaflet perforation, and bleeding diathesis. Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.For a list of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use. For countries that use electronic instructions for use (eIFUs), consult instructions for use at medtronic.com/manuals. UC202409145 EN

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