The US FDA’s approval was based on the (TRILUMINATE) pivotal study that compared the safety and effectiveness of the TriClip system with medical therapy for treating severe tricuspid regurgitation patients at intermediate or higher risk for open-heart surgery
The trial demonstrated improved TR grade from severe to moderate or less in 90% of participants that sustained for a year & 98% of them were free from major AEs at 30 days improving their quality of life
The TriClip’s TEER technology, administered via vein in the leg, repairs the tricuspid valve by clipping flaps of tissue together enabling blood flow in the correct direction without open-heart surgery
Ref: Abbott | Image: Abbott
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