New Town, Pennsylvania, May 27, 2021 / PRNewswire /- Micro-interventional device (MID) The MIA ™ -T percutaneous tricuspid annulus plasty system has received a breakthrough device designation from the US Food and Drug Administration (FDA). The MIA-T system treats moderate to severe tricuspid regurgitation (TR) via a 12F catheter-based system.
MID is developing a unique transcatheter cardiac repair (TCR) technology to meet the unmet needs in the treatment of structural heart disease. The company’s products are designed to achieve surgical effects with percutaneous safety.
The safety and performance of MIA-T has been demonstrated in the Study of Transcatheter Tricuspid Annular Repair, an STTAR conducted at six clinical facilities in Europe. Promising 12-month follow-up data was submitted for CE Mark approval in December 2020. The company will receive both CE Mark approval and IDE approval to begin critical research on STTAR-US by the end of 2021. On hold.
“A significant 2 and 3 grade reduction in tricuspid regurgitation (TR) was achieved, maintained at 12 months of follow-up, and the incidence of device or procedure-related death, stroke, or myocardial infarction. Not reported. ” Michael Whitman, President and CEO of MID. “The achieved reduction in TR has significantly improved the quality of life of these patients, with an average improvement of 36% from the baseline of the Minnesota Heart Failure Patients Survey.”
Breakthrough device designation allows MID to interact more frequently and in a timely manner with the FDA, including “sprint discussions”, data development planning support, and regular status updates through conference calls and face-to-face meetings. This will accelerate the clinical trial process as a company. Focus on US-based clinical trials.
“There is growing interest in percutaneous treatment of tricuspid regurgitation as early clinical data on catheter-based technology show the potential to improve quality of life in patients with severe TR.” .. Matthew Williams, MD, Chief of Adult Cardiac Surgery, Director of CVI Structural Heart Disease Program at NYU Langone Medical Center. “MIA-T appears to have advantages in treating a wide range of patients and overall ease of use. Encouraged by the results of the European STTAR study, we are excited about the US IDE approval.”
“The relatively simple, safe and secure MIA-T system helps many patients suffering from moderate to severe tricuspid regurgitation. United States of America, ” Michael Whitman, Continued. “More than 1.6 million people in the United States alone suffer from TR, and today only 8,000 are undergoing surgical treatment.* We hope that the breakthrough device designation will speed up the process of commercialization and allow patients, physicians, and healthcare systems to benefit from this technology. “
* Data on file
Micro Interventional Devices, Inc. About (MID):
MID is a leader in transcatheter cardiac repair (TCR) using a unique percutaneous compliance fixation technique that emulates open surgery to address structural disorders of the heart.
MIA-T utilizes a unique compliant PolyCor ™ anchor, the world’s first low mass polymer implant designed to comply with normal physiological valve function. MIA-T implants are designed to make the heart tissue supple and compliant when deployed.
MID is a privately held medical device company developing minimally invasive solutions for structural heart disease. The main focus of MID is to repair the tricuspid and mitral valves while the heart is beating, eliminating the need for cardiopulmonary bypass surgery.
Company contact information:
Micro Interventional Devices, Inc.
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SOURCE Micro Interventional Devices, Inc.
FDA is Micro Interventional Devices, Inc.MIA ™ -T Grants Breakthrough Device Designation for Percutaneous Tricuspid Valve Plasty System | Around the Web-Pennsylvania
Source link FDA is Micro Interventional Devices, Inc.MIA ™ -T Grants Breakthrough Device Designation for Percutaneous Tricuspid Valve Plasty System | Around the Web-Pennsylvania