The application includes data from the STTAR clinical study with a one-year follow-up period.
NEWTOWN, Pa. Jan. 29, 2021 / PRNewswire / – Micro Interventional Devices, Inc. ™ (MID) announced today that it has provided the technical documentation required for CE approval of its MIA-T ™ Percutaneous Tricuspid Annuloplasty System for tricuspid valve repair submitted to the notified body. With the CE mark, MID could market the MIA-T in the European Union in countries that fall under the European Medical Device Regulations (MDR). MID expects to receive approval in 2021. This would provide a new treatment option for millions of patients who are currently at too high a risk for the standard treatment, open surgical repair with cardiopulmonary bypass.
The MIA-T system was clinically evaluated as part of the STTAR study (Study of Transcatheter Tricuspid Annular Repair), which was carried out at six European hospitals. The image-guided procedure uses fluoroscopy and 3-D echocardiography to treat patients with tricuspid regurgitation while the heart is beating, eliminating the need for cardiopulmonary bypass. This less invasive treatment option would enable many more patients to seek treatment for the disease.
“The CE Mark application is an important milestone for MID,” said Michael Whitman , President and CEO. “It could enable MID to offer a safe and effective therapeutic option for patients who are currently inadequate with medical and surgical options , and the course would be set for the next big growth phase of this company. It should also be mentioned that this application is submitted under the current EU Medical Device Regulation (MDR) 2017/745. ”
31 patients have so far been treated with the MIA-T technology. The first data indicate that the significant reduction in the dimension of the annulus and tricuspid regurgitation achieved with MIA-T continues after one year. The data also show significant improvements in quality of life for patients treated with the MIA-T system. There were no device- or procedure-related deaths, strokes, or myocardial infarctions during the 12-month follow-up period. The technology is currently not approved for commercial use.
“The clinical data from STTAR prove the safety and performance of the MIA T-Systems,” says Willard Hennemann , PhD, Chief Science Officer of MID . “The positive clinical results of the study, as well as the short time of the procedure and the steep Learning curve, suggest that the MIA-T system has the potential to be adopted as the standard therapy for the treatment of moderate to severe tricuspid regurgitation after CE approval. ”
In addition, MID continues to work closely with the FDA on the Investigational Device Exemption (IDE) application to conduct an STTAR clinical trial in the United States . A multi-center study will be conducted in 30 locations in the United States. MID hopes that the agency’s approval will arrive in time to begin the US trial later this year, and then receive a premarket approval (PMA).
About Micro Interventional Devices, Inc. (MID):
MID is a global leader in transcatheter heart repair (TCR) using its proprietary percutaneous compliant fixation technology that emulates open surgical procedures for the treatment of heart disease.
MIA-T uses proprietary, compliant PolyCor ™ anchors, the world’s first ultra-low mass polymeric implant designed to conform to normal valve physiological function. After insertion, the MIA-T implant connects to and corresponds to the heart tissue.
MID is a privately held medical technology company that develops minimally invasive solutions for structural heart disease. MID’s primary focus is on repairing the tricuspid and mitral valves while the heart is beating, eliminating the need for cardiopulmonary bypass surgery.
Corporate
contact : Micro Interventional Devices, Inc.
Katherine Whitman
Director of Marketing
215 600 1270
info@microinterventional.com
www.microinterventional.com
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SOURCE Micro Interventional Devices, Inc.
