News | Annuloplasty Rings | October 30, 2017

Second Micro Interventional Devices Annuloplasty System Successfully Implanted

Company plans to initiate first-in-human percutaneous portion of STTAR Study in Q4 2017

Second Micro Interventional Devices Annuloplasty System Successfully Implanted

October 30, 2017 — Micro Interventional Devices Inc. (MID) recently announced the second successful implantation of its MIA (Minimally Invasive Annuloplasty) technology. The patient was enrolled in the first arm of the STTAR (Study of Transcatheter Tricuspid Annular Repair) clinical trial studying the safety and efficacy of MID's MIA device designed to eliminate or greatly reduce tricuspid regurgitation

This is the second patient enrolled in the surgical arm of the STTAR study utilizing a bicuspidization approach. The procedure took less than 14 minutes. The rapid, reproducible deployment of the MIA implant resulted in a 24 percent reduction in annular area and a reduction in tricuspid valve regurgitation from moderate regurgitation pre-procedure to trace regurgitation post-procedure. As with the other four STTAR cases, there were no intraoperative complications or adverse events observed or reported.   

Enrollment in the surgical arm of the STTAR Trial continues with Prof. Kestutis Rucinskas, M.D., chief of cardiac surgery, and Prof. Audrius Aidietis, M.D., chief of cardiology and angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania.

The percutaneous arm of the STTAR study is anticipated to commence in Q4 2017. Preclinical testing of the delivery catheter at major universities has proven that MID's 12 French delivery system is effective under imaging guidance in procedures completed in less than one hour. The delivery system is simple to use, according to MID, and it is anticipated that the low mass implant will preserve physiological function and all future options for intervention, differentiating MID from other players in the tricuspid space.

MIA utilizes proprietary, compliant PolyCor anchors, the world's first low-mass polymeric implant designed to comply with normal physiological valvular function. The MIA implant is engineered to plicate and comply with cardiac tissue once deployed.

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