Micro Interventional Devices MIA-T Tricuspid Annuloplasty System Granted FDA Breakthrough Device Designation

May 27, 2021—Micro Interventional Devices (MID) has received FDA Breakthrough Device designation for its MIA-T percutaneous tricuspid minimally invasive annuloplasty system. The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12-F catheter-based system.

The company noted that 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 toward a United States–based clinical trial.

According to the company, the safety and performance of MIA-T has been demonstrated in STTAR, a study of transcatheter tricuspid annular repair conducted at six European clinical sites. Publication of the STTAR data is also pending.

In December 2020, 12-month follow-up data from STTAR were submitted to support the company’s application for CE Mark approval of the MIA-T device. MID anticipates receiving CE Mark approval in Europe as well as approval of an investigational device exemption (IDE) from the FDA to initiate the STTAR-US pivotal study by the end of 2021.

“There is growing interest in the percutaneous treatment of TR as early clinical data for catheter-based technologies show promise for improving the quality of life in patients with severe TR,” commented Mathew Williams, MD, in MID’s announcement. “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 United States IDE approval.” Dr. Williams is Chief, Division of Adult Cardiac Surgery and Director, CVI Structural Heart Disease Program at NYU Langone Medical Center in New York, New York.

Additionally, Michael Whitman, President and Chief Executive Officer of MID, stated, “Significant two and three grade reductions in 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. 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.”

Mr. Whitman continued, “The relative simplicity, safety, and security of the MIA-T system will help many patients [with] moderate-severe TR in the United States. Over 1.6 million people in the United States alone [have] 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 health care system can benefit from this technology.”