Enrollment of First European Subject in Transcatheter Tricuspid Repair Study Enrolled in SCOUT II Study with Trialign System for Transcatheter Tricuspid Repair

June 13, 2017

Enrollment of first European subject in transcatheter tricuspid repair study was announced today. The SCOUT II Study using the Trialign System has commenced at leading medical centers across Europe.

Mitralign Inc., an innovative developer of transcatheter tricuspid and mitral valve repair solutions, announced today the commencement of its SCOUT II study in Europe, with the Trialign System for the treatment of patients suffering from tricuspid regurgitation.

FIRST EUROPEAN CENTER ENROLLING SCOUT II:  “We are pleased to be the first center in Europe to commence enrolling in SCOUT II,” commented Azeem Latib, M.D., Interventional Cardiologist San Raffaele Scientific Institute, Milan, Italy. “This is an exciting therapy which allows us to deliver a minimally invasive solution to a group of patients who have limited treatment options. The procedure was a great success, as we saw acute reduction in tricuspid regurgitation and the patient was able to go home shortly thereafter.”

“The tricuspid valve is the last major valve opportunity in the structural heart space,” said Rick Geoffrion, Chief Executive Officer of Mitralign. “The 6-month data from our SCOUT I EFS Study in the United States has provided early safety and efficacy signals that we plan to build on with SCOUT II.”

Additional SCOUT I data will be presented during the Satellite Symposium titled, Trialign: The Next Era in Tricuspid Repair, on Thursday, June 15, 2017 from 12:30-1:30 PM at the Transcatheter Valve Therapies (TVT) Conference in Chicago, IL: Sheraton Grand Chicago: Room Chicago VII.

The Trialign™ System is an investigational device and is exclusively for clinical investigation. It is limited by Federal (or United States) Law to investigational use only. It is not available for sale or commercial distribution. The Trialign System is currently enrolling in the SCOUT I Early Feasibility Study and the SCOUT II CE Mark Study.

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