June 27, 2017 — Mitralign Inc. announced the commencement of its SCOUT II study in Europe, with the Trialign System for the transcatheter treatment of patients suffering from tricuspid regurgitation.
“We are pleased to be the first center in Europe to commence enrolling in SCOUT II,” commented Azeem Latib, M.D., interventional cardiologist at 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 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.
Six-month data from SCOUT I was presented at the Transcatheter Valve Therapies (TVT) conference, June 15-17 in Chicago.
For more information: www.mitralign.com