10. Micro Interventional Devices: MIA-T percutaneous tricuspid annuloplasty catheter
Micro Interventional Devices received FDA breakthrough device designation for its MIA-T percutaneous tricuspid annuloplasty system in May 2021.
The MIA-T system treats moderate to severe tricuspid regurgitation through a 12F catheter-based system. It has an ergonomic handle that deploys the implant with the release of a safety and press of the deployment button. PolyCor anchors in the implant are loaded in the distal end of the delivery system and are deployed into the tricuspid annulus in 4/1000ths of a second.
Micro Interventional Devices studied the safety and performance of the device in a study across six European clinical sites. The 12-month data was submitted for CE mark approval in December. The company anticipated CE mark approval and IDE approval to initiate a pivotal trial in the U.S. by the end of the year.
The study showed two and three grad reductions in tricuspid regurgitation that were achieved acutely and were maintained at 12-month follow-ups with no reported incidents of device or procedure-related mortality. Patients on the study reported an average improvement of 35% from baseline on the Minnesota Living with Heart Failure Questionnaire, according to the company.
Read more about the breakthrough device designation.