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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.

 

STTAR-EU RESULTS

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

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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.