STTAR EUROPEAN CLINICAL TRIAL
STTAR CE MARK STUDY - THE STUDY OF TRANSCATHETER TRICUSPID ANNULAR REPAIR IN EUROPE
STTAR is a multi-center CE-Mark study evaluating the safety and performance of MIA-T for the treatment of tricuspid regurgitation.
Thirty-one patients have been treated with the MIA-T technology to date. The initial data indicate that significant reductions in annular dimensions and tricuspid regurgitation achieved acutely with MIA-T are durable at one year follow-up. The data also indicate significant improvements in Quality of Life for patients treated with the MIA-T system. There were no device or procedure-related deaths, strokes or myocardial infarctions reported for any patient throughout the 12month follow-up period.
MIA-T is an Investigational Device ONLY. The technology has been submitted for CE Mark approval. The company plans to commercialize the product in 2021.
STTAR EUROPEAN CLINICAL TRIAL SITES
VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS
KAUNAS UNIVERSITY HOSPITAL
CARDINAL WYSZYNSKI NATIONAL INSTITUTE OF CARDIOLOGY
PAULS STRADINS CLINICAL UNIVERSITY HOSPITAL
AARHUS UNIVERSITY HOSPITAL
STTAR-US PIVOTAL CLINICAL TRIAL
STTAR-US - THE STUDY OF TRANSCATHETER TRICUSPID ANNULAR REPAIR IN THE UNITED STATES
Micro Interventional Devices is preparing for a US Clinical Trial studying the safety and efficacy of the MIA-T system. The technology was granted FDA Breakthrough Designation in December 2019. The company anticipates receipt of approval to commence a US study in 2021.