Micro Interventional Devices Receives FDA Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System

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.

Micro Interventional Devices 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 have 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.  Micro Interventional Devices 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 Micro Interventional Devices.  “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 Micro Interventional Devices 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

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy