Micro Interventional Devices said today it completed the 2nd successful procedure with its Mia device designed for percutaneous mitral and tricuspid repairs.
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 Friday, February 3rd, we successfully deployed eight MIA implants into the patient’s tricuspid annulus. It was impressive that the clinicians only took 14 minutes to deploy the technology. Prior to deployment of the MIA implants the intraoperative saline injection leak test demonstrated a lack of leaflet coaptation. After deployment of the MIA implants the saline injection leak test revealed full leaflet coaptation and a competent valve. The acute 48% reduction in valve area observed was comparable to that achieved with the current surgical standard of care. This reduction was maintained at hospital discharge,” chief science officer Willard Hennemann said in a prepared statement.
The device was used in a procedure on in the company’s STTAR clinical study for a 60-year old man with severe mitral and moderate tricuspid regurgitation, the company said. The procedure was performed by Dr. Kestutis Rucinskas and Dr. Audrius Aidietis at Vilnius, Lithuania’s Vilnius University Hospital Santariskiu Clinic.
A total of 8 Mia implants were deployed into the patient’s tricuspid annulus in a 270-degree partial ring pattern concomitant with mitral valve repair, the company said, in a procedure which took 14 minutes and resulted in a 48% acute reduction in annular area.
“Enrolling patients in the first arm of the STTAR Study has demonstrated the feasibility of the procedure and the capability of the MIA implant to significantly reduce annular dimensions. These initial results are extremely encouraging and support our thesis that MIA is safe, simple, and secure. We look forward to continued enrollment and further favorable results,” founder, prez & CEO Michael Whitman said in a press release.
The 1st patient in the trial was treated on Dec. 6, and had no reported or observed adverse events at a 30-day follow-up.