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Devices Interventional Cardiology FDA

 News Release - May 27, 2021

FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA(TM)-T Percutaneous Tricuspid Annuloplasty System

NEWTOWN, Pa., May 27, 2021 -- (Healthcare Sales & Marketing Network) -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA™-T Percutaneous Tricuspid Annuloplasty System. The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system.

MID develops proprietary Transcatheter Cardiac Repair (TCR) technologies addressing unmet needs in the treatment of structural heart disease. The company's products are designed to achieve surgical efficacy with percutaneous safety.

The safety and performance of MIA-T has been demonstrated in the STTAR, Study of Transcatheter Tricuspid Annular Repair, conducted at 6 European clinical sites. The encouraging 12-month follow up data was submitted for CE Mark approval in December 2020. The company anticipates receiving both CE Mark approval and IDE approval to initiate the STTAR-US pivotal study by the end of 2021. Publication of the STTAR data is also pending.

"Significant two and three grade reductions in tricuspid regurgitation (TR) have been achieved acutely and maintained at 12-month follow-up with no reported incidence of device or procedure-related mortality, stroke or myocardial infarction," stated Michael Whitman, President and CEO of MID. "The reductions in TR achieved have significantly improved the quality of life for these patients, resulting in an average improvement of 36% from baseline on the Minnesota Living with Heart Failure Questionnaire."

Breakthrough device designation will allow MID to have more frequent and timely interactions with FDA, including "sprint discussions," support on data development plans, and regular status updates via teleconferences and face-to-face meetings to expedite the clinical trial process as the company shifts its focus towards a US-based clinical trial.

"There is growing interest in the percutaneous treatment of tricuspid regurgitation as early clinical data for catheter-based technologies show promise for improving the quality of life in patients with severe TR," stated Mathew Williams, MD, Chief, Division of Adult Cardiac Surgery and Director, CVI Structural Heart Disease Program at NYU Langone Medical Center. "MIA-T appears to have advantages in treating a broad range of patients and in overall ease of use. I am encouraged by the results of the European STTAR study and am excited for the US IDE approval."

"The relative simplicity, safety and security of the MIA-T system will help many patients suffering from moderate-severe tricuspid regurgitation in the United States," Michael Whitman, continued. "Over 1.6 million people in the US alone suffer from TR and only 8,000 receive surgical treatment today.* We expect that breakthrough device designation will speed the process to commercialization so patients, physicians and the healthcare system can benefit from this technology."

*Data on File

About Micro Interventional Devices, Inc. (MID):

MID is a leader in Transcatheter Cardiac Repair (TCR) utilizing its proprietary percutaneous compliant fixation technology that emulates open surgical procedures addressing structural diseases of the heart.

MIA-T utilizes proprietary, compliant PolyCor™ anchors, the world's first low mass polymeric implant designed to comply with normal physiological valvular function. The MIA-T implant is engineered to plicate and comply with cardiac tissue once deployed.

MID is a privately held medical device company developing minimally invasive solutions for structural heart disease. MID's primary focus is repairing the tricuspid and mitral valves while the heart is beating, eliminating the need for cardiopulmonary bypass surgery.

Source: Micro Interventional Devices

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