Micro Interventional Devices Begins Study of Minimally Invasive Annuloplasty Technology for Mitral and Tricuspid Repair
December 19, 2016—Micro Interventional Devices, Inc. (MID) announced the first clinical implantation of its MIA minimally invasive annuloplasty technology for mitral and tricuspid repair.
The MIA implant is made from the company's PolyCor anchors and MyoLast implantable elastomer. The MIA device reduces annular dimensions, and thus regurgitation, after deployment in the patient's native annulus. The annular reduction is achieved without sutures or other intervention.
According to MID, this implantation represents the first clinical enrollment in the company's STTAR (Study of Transcatheter Tricuspid Annular Repair) clinical study. STTAR is a multicenter safety and performance study being conducted in Europe.
The procedure was performed by Prof. Kestutis Rucinskas, MD, and Prof. Audrius Aidietis, MD. Prof. Rucinskas is Chief of Cardiac Surgery, and Prof. Aidietis is Chief of Cardiology and Angiology at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania.
The company reported that the MIA device was implanted during a minimally invasive tricuspid repair procedure concomitant with mitral valve repair. There were no intraoperative complications or adverse events observed or reported. Postprocedural patient recovery has been uneventful.
On December 6, nine MIA implants were successfully deployed in the first patient's tricuspid annulus during a minimally invasive tricuspid repair procedure. A significant reduction in valve area was observed after the procedure. The STTAR study will continue enrolling additional patients who will be followed to assess the long-term effect of MIA on valve insufficiency. The STTAR study is the MID's first step in demonstrating the safety and performance of MIA as a catheter-based mitral and tricuspid repair system, advised MID.