Micro Interventional Devices said yesterday it completed the 1st clinical implantation of its MIA implant in the STTAR clinical trial of the device, which is designed for minimally invasive mitral and tricuspid repair procedures.
The Newtown, Penn.-based company’s MIA implant is composed of PolyCor anchors and MyoLast implantable elastomer, and is designed to reduce annular dimensions and regurgitation after being deployed in the patient’s native annulus.
“On Tuesday, December 6th 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,” MID chief scientific officer Willard Hennemann said in a prepared statment.
The 1st procedure was performed by Dr. Kestutis Rucinskas and Dr. Audrius Aidietis at Vilnius, Lithuania’s Vilnius University Hospital Santariskiu Clinic, Micro Interventional Devices said. No intraoperative complications or adverse events were reported.
“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. 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,” MID founder, prez & CEO Michael Whitman said in a press release.
In July, MID said it won FDA 510(k) clearance for its Permaseal transapical access and closure device.
The Permaseal device is designed to allow surgeons to access and close the left-ventricle without having to suture the myocardium using the companies compliant soft-tissue PolyCor anchor technology.