Micro Interventional Devices (MID), announced that it has successfully completed the first clinical implantation of its proprietary MIA technology for minimally invasive mitral and tricuspid repair. The MIA implant is made from PolyCor anchors and MyoLast implantable elastomer.
The MIA device reduces annular dimensions, and thus regurgitation, following deployment in the patient's native annulus. The annular reduction is achieved without sutures or other intervention. This implantation represents the first clinical enrollment in the company's STTAR clinical study.
STTAR (the Study of Transcatheter Tricuspid Annular Repair) is a multi center safety and performance study being conducted in Europe.
MIA was implanted during a minimally invasive tricuspid repair procedure concomitant with mitral valve repair. The procedure was performed by Professor Kestutis Rucinskas, MD, Chief of Cardiac Surgery, and Professor Audrius Aidietis, MD, Chief of Cardiology and Angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania.
There were no intraoperative complications or adverse events observed or reported. Post-procedural patient recovery has been uneventful.
"On Tuesday, December 6th we successfully deployed nine MIA Implants in our first patient's tricuspid annulus during a minimally invasive tricuspid repair procedure," Willard Hennemann, PhD, MID's Chief Science Officer, commented.
"A significant reduction in valve area was observed post procedure. We look forward to enrolling additional patients in the STTAR study and to following these patients to assess the long term effect of MIA on valve insufficiency."
There are approximately 1.1 million patients in the United States who are not currently being treated for mitral and tricuspid regurgitation because most candidates are not eligible for surgery, today's standard of care.1 The major advantage of MIA is its potential to address this large, underserved patient population by enabling percutaneous repair procedures.
"Utilizing MIA in the STTAR study is the first step in demonstrating the safety and performance of a catheter-based mitral and tricuspid repair system," said Michael Whitman, MID's Founder, President & CEO.
"This data point is encouraging. We are ever more confident of achieving our goal of a truly percutaneous mitral and tricuspid repair. It is our objective to make MIA safe, simple and secure."