Abbott to Initiate World’s First Study to Evaluate its TriClip Transcatheter Tricuspid Valve Repair System in the US

Abbott to Initiate World's First Study to Evaluate its TriClip Transcatheter Tricuspid Valve Repair System in the US

Shots:

  • Abbott to launch TRILUMINATE pivotal study to evaluate TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation. In TRILUMINATE pivotal study, ~700 patients are expected to enroll, randomized to receive either the TriClip device or medical therapy and followed for 5yrs. in the US, Canada and EU
  • The launch of the TRILUMINATE Pivotal IDE study follows smaller TRILUMINATE study resulting 86.6% reduction in TR severity after 30 days treatment and an improvement in heart failure symptoms, conducted in the US & EU
  • Abbott’s TriClip valve repair system is built on its MitraClip system which is commercially available in the US since 2013 and in Europe since 2008. TriClip device was accepted for national reimbursement consideration via FDA’s Parallel Review program

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