US-based Micro Interventional Devices (MID) has completed the first clinical implantation of its MIA technology for minimally invasive mitral and tricuspid repair.
Made from PolyCor anchors and MyoLast implantable elastomer, the device reduces annular dimensions and regurgitation after it is deployed in the patient's native annulus.
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The implantation represents the first clinical enrollment in the company's Study of Transcatheter Tricuspid Annular Repair (STTAR) multi center safety and performance clinical study being conducted in Europe.
MID's chief science officer Willard Hennemann said: "On Tuesday, 6 December we successfully deployed nine MIA Implants in our first patient's tricuspid annulus during a minimally invasive tricuspid repair procedure.
"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."
The implantation of MIA took place during a minimally invasive tricuspid repair procedure concomitant with mitral valve repair.
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By GlobalDataMID's founder, president, and chief executive officer (CEO) Michael Whitman said: "Utilising MIA in the STTAR study is the first step in demonstrating the safety and performance of a catheter-based mitral and tricuspid repair system.
"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."
When the procedure was performed at the Vilnius University Hospital Santariskiu Clinic in Vilnius, no intraoperative complications or adverse events were observed or reported. MIA can address underserved patient population by enabling percutaneous repair procedures.
