First Clinical Tricuspid Bicuspidization Procedure Completed Using Micro Interventional Devices’ MIA Technology
September 7, 2017—Micro Interventional Devices, Inc. (MID) has completed a first-in-human tricuspid valve bicuspidization procedure using the company's minimally invasive annuloplasty (MIA) technology. The successful bicuspidization resulted in a 34.5% reduction in valve area, reducing the patient's tricuspid regurgitation from severe/moderate to trace. The patient was the fourth enrolled in MID's STTAR (Study of Transcatheter Tricuspid Annular Repair) trial. All four patients have been successfully treated with 100% procedural success and no adverse events have been reported, stated the company.
The company noted that the treatment of the fourth patient represented an evolution in the clinical use of MIA, as it was the first time the technology was utilized to perform a bicuspidization of the patient's tricuspid valve, which provided a superior outcome and was easier to perform than the procedures on the initial three patients. The acute results for this patient appear comparable to open bicuspidization procedures, stated the company.
According to MID, the fourth patient was enrolled in the STTAR study and treated with a second-generation MIA implant that allows for greater annular reduction with fewer implants. The procedure was performed by Prof. Kestutis Rucinskas, MD, Chief of Cardiac Surgery, and Prof. Audrius Aidietis, MD, Chief of Cardiology and Angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania.
The company stated that the annular reduction may prove to be easier, faster, and more durable by using a bicuspidization approach with the second-generation technology. The tricuspid repair portion of the procedure was completed in 15 minutes.
MIA utilizes PolyCor anchors, which are low-mass polymeric implant designed to comply with normal physiologic valvular function. The MIA implant is engineered to plicate and comply with cardiac tissue once deployed.