NEWTOWN, Pa., May 27, 2021 /PRNewswire/ — 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.
World’s first annuloplasty system for mitral and tricuspid repair incorporating proprietary PolyCor™ and MyoLast™ technologies.
Proceeds to Fund Enhancement and CE Mark Approval of the Permaseal(TM) Transapical Access and Closure Technology
Bethlehem, PA – January 14, 2013 – Micro Interventional Devices, Inc.™ (MID), an emerging cardiovascular medical device company, announced today it has secured $3.5 million of its expected $5 million Series B financing. The initial tranche was led by Originate Ventures with existing investor, Battelle Ventures, LP, also participating in the round. In conjunction with the financing Mike Gausling, Managing Partner of Originate Ventures, will join the MID Board of Directors.
The funding will be used to support the ongoing development of the Permaseal™ product, advance the STASIS clinical study (Sutureless Transapical Access and Closure Study) and obtain CE Mark approval for Permaseal. The funding will also support MIDʼs research and development initiatives focused on developing its percutaneous transapical and large bore femoral access and closure devices.
“The market for transcatheter aortic valve implantation is expected to grow rapidly over the next several years as innovation continues to improve and simplify the procedure,” said Mike Gausling, Managing Partner of Originate Ventures. “Originate Ventures believes that Permaseal represents a significant opportunity given these market dynamics. I am excited to be joining MIDʼs Board of Directors and to work with management to ensure the successful clinical and commercial development of this revolutionary access and closure technology.”
Permaseal is the first transapical access device to enable true “self-sealing,” sutureless cardiac access and closure. The device is designed to enable a range of structural heart repair procedures including transcatheter aortic valve implantation (TAVI) and mitral valve replacement and repair.
“Closing the first tranche in our Series B, and the addition of Mike Gausling to MIDʼs Board, are key milestones in the growth of MID and ongoing development of Permaseal,” stated Michael Whitman, President and CEO of MID. “As TAVI becomes more widespread there is a critical need for efficient cardiac access and closure devices. We believe the Permaseal platform is a true game-changing technology, and we look forward to completing the STASIS trial and securing CE Mark in order to fulfill this unmet therapeutic need.”
About Micro Interventional Devices, Inc:
Micro Interventional Devices, Inc. (MID) is an emerging cardiovascular medical device company founded in May 2010. MID is developing solutions for transcatheter aortic valve implantation (TAVI), transcatheter mitral valve replacement and repair and other emerging structural heart repair procedures. The company is developing proprietary technology based on a breakthrough in soft-tissue anchoring and associated delivery devices that enable off-pump procedures. To learn more, please visit www.microinterventional.com.
Micro Interventional Devices, Inc.
Marketing Communications Manager
Tiberend Strategic Advisors, Inc.