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 12 month 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
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.