Micro Interventional Devices, Inc.™ Completes First Clinical Tricuspid Bicuspidization Procedure Utilizing MIA™ Technology

NEWTOWN, Pa., Micro Interventional Devices, Inc.™ (MID) has successfully completed the first in human tricuspid valve bicuspidization procedure utilizing its MIA (Minimally Invasive Annuloplasty) 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 to be enrolled in MID's STTAR Trial (Study of Transcatheter Tricuspid Annular Repair).  All four patients have been successfully treated with 100% procedural success and no adverse events reported.

"This patient represents an evolution in the clinical use of MIA.  This is the first time MIA was utilized to perform a bicuspidization of the patient's tricuspid valve," stated Michael Whitman, MID's President and CEO.  "The shift to a bicuspidization approach on our fourth patient provided a superior outcome and was easier to perform than our initial three patients.  This is not surprising as clinical experience is applied to greater procedural affect.  The acute results for this patient appear comparable to open bicuspidization procedures." 

The fourth patient enrolled in the STTAR study on Wednesday, August 23rd was treated with a second generation MIA implant that allows for greater annular reduction with fewer implants. 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.  As with the other STTAR cases, there were no intraoperative complications or adverse events observed or reported. 

By using a bicuspidization approach with the second-generation technology, the annular reduction may prove to be easier, faster and more durable.  The tricuspid repair portion of the procedure was completed in 15 minutes.

"This fourth clinical case marks a significant milestone for the company as the MIA technology continues to prove effective in open surgery," stated Michael Whitman, President and CEO of MID.  "With the confirmation of the implant's effectiveness, our next step is to convert this technology to a 12F catheter-based delivery system which has been in development for some time.  We expect to perform the first percutaneous bicuspidization with MIA in Q4 of this year."

"The MIA deployment took approximately 15 minutes in open surgery.  Therefore, we expect the percutaneous deployments to take less than thirty minutes," stated Willard Hennemann, PhD, MID's Chief Science Officer.  "MIA percutaneous can be deployed from the atrium via transfemoral access, avoiding subvalvular structures, and improving the ease of use.  This may open the door for treatment of the approximately 2.3 million patients worldwide who are not currently being treated for mitral and tricuspid regurgitation, as they are unable to tolerate open surgery.  This first in human result indicates that MIA will be a viable treatment for functional tricuspid disease."

MIA utilizes proprietary compliant PolyCorTM anchors, the world's first low mass polymeric implant designed to comply with normal physiological valvular function.  The MIA implant is engineered to plicate and comply with cardiac tissue once deployed.