Plans for FIH Percutaneous in Q4 2017
NEWTOWN, Pennsylvania, Oct. 23, 2017 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID) announced today the second successful implantation of its MIA (Minimally Invasive Annuloplasty) technology. The patient was enrolled in the first arm of the STTAR (Study of Transcatheter Tricuspid Annular Repair) clinical trial studying the safety and efficacy of MID's MIA device designed to eliminate or greatly reduce tricuspid regurgitation.
This is the second patient enrolled in the surgical arm of the STTAR study utilizing a bicuspidization approach. The procedure took less than 14 minutes. The rapid, reproducible deployment of the MIA implant resulted in a 24% reduction in annular area and a reduction in tricuspid regurgitation from moderate regurgitation pre-procedure to trace regurgitation post-procedure. As with the other four STTAR cases, there were no intraoperative complications or adverse events observed or reported.
Enrollment in the surgical arm of the STTAR Trial continues with 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.
The percutaneous arm of the STTAR study is anticipated to commence in Q4 2017. Preclinical testing of the delivery catheter at major universities has proven that MID's 12F delivery system is effective under imaging guidance in procedures completed in less than one hour. The delivery system is simple to use and it is anticipated that the low mass implant will preserve physiological function and all future options for intervention, differentiating MID from other players in the tricuspid space.
"If the catheter results that we have been collecting in our weekly preclinical labs translate to the clinic, MIA is poised to be an effective and simple transcatheter device for the treatment of tricuspid regurgitation," stated Willard Hennemann, PhD, MID's Chief Science Officer. "We are excited about the potential for MIA to be a technique that is easily adaptable as a treatment of choice for the reduction and/or elimination of tricuspid regurgitation."
"If we combine the successful clinical results from the surgical arm of the STTAR study with the ease of use of the MIA delivery system we have experienced preclinically, transcatheter MIA will prove to be a very significant technology," Michael Whitman, MID's President and CEO, stated. "There is currently no medical or interventional solution for over 1.1 million patients suffering from tricuspid regurgitation in the US alone. We believe we are on the cusp of developing a technology that will expand the treatment options for this large patient population, increasing the quality of life for those patients who are eligible for treatment."
MID continues to work to develop a safe and reliable treatment option for tricuspid and mitral regurgitation. The team looks forward to continuing its path towards proving the safety and efficacy of this truly percutaneous device in the upcoming months.
MIA utilizes proprietary, compliant PolyCor™ 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.
About Micro Interventional Devices, Inc. (MID):
MID is the world leader in percutaneous transcatheter compliant fixation technology addressing unmet needs in structural heart disease.
SOURCE Micro Interventional Devices, Inc.