World's first annuloplasty system for mitral and tricuspid repair incorporating proprietary PolyCor™ and MyoLast™ technologies.
NEWTOWN, Pennsylvania, March 1, 2017 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID), announced today that it has successfully completed the second clinical case with its proprietary MIA™ technology for percutaneous mitral and tricuspid repair. This is the second successful clinical procedure and the second patient enrolled in the company's STTAR clinical study. STTAR, the Study of Transcatheter Tricuspid Annular Repair, is a multi center safety and performance study being conducted in Europe.
The patient was a 60-year-old man with severe mitral and moderate tricuspid regurgitation. Eight MIA implants were deployed into the patient's tricuspid annulus in a 270-degree partial ring pattern concomitant with mitral valve repair. The MIA deployments took 14 minutes to complete and resulted in a 48% acute reduction in annular area. The annular reduction is achieved without sutures or other intervention.
The first two procedures were 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 first case, there were no intraoperative complications or adverse events observed or reported and post-procedural patient recovery has been uneventful. The first patient, treated on December 6th, 2016, has now been followed to 30 days with no observed or reported adverse events. The reduction in annular area observed at hospital discharge has been maintained at 30-day follow-up.
"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," Willard Hennemann, PhD, MID's Chief Science Officer, commented. "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."
The MIA implant is made from the proprietary PolyCorTM anchors bonded to the proprietary, self-tensioning, implantable elastomer called MyoLastTM. This is the world's first low mass polymeric implant designed specifically to comply with normal physiological valvular function. The MIA implant is specifically engineered to plicate and comply with cardiac soft-tissue once deployed.
"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," said Michael Whitman, MID's Founder, President & CEO. "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."
There are approximately 2.3 million patients worldwide who are not currently being treated for mitral and tricuspid regurgitation because most candidates are not eligible for surgery, today's standard of care.1 The major advantage of MIA is its potential to address this large, underserved patient population by enabling percutaneous valve repair procedures.
About Micro Interventional Devices, Inc. (MID):
MID is the world leader in percutaneous transcatheter compliant fixation technology addressing unmet needs in structural heart disease.
1 Internal Estimates Based off of References on File
SOURCE Micro Interventional Devices, Inc.