Percutaneous Annuloplasty System for Tricuspid Repair
MIA-T is proving to be a simple, safe and secure technology designed to treat tricuspid regurgitation percutanesouly.
The safety and performance of the MIA-T System was clinically evaluated in the STTAR, Study of Transcatheter Tricuspid Annular Repair, clinical trial that was conducted at six European hospitals. The image-guided procedure relies on fluoroscopy and 2D and 3D echocardiography to treat patients suffering from tricuspid regurgitation while the heart is beating, obviating the need for cardiopulmonary bypass. This less invasive treatment option would dramatically increase the number of patients who are able to receive treatment for this disease.
MIA-T is an Investigational Device Only. The device is not for sale.
The MIA-T procedure is intended to replicate a surgical annuloplasty procedure on the end of a catheter, reducing annular area and ultimately reducing tricuspid regurgitation. The animation on the left articulates the MIA-T procedure.
The MIA-T delivery system is a 12F catheter. The ergononic handle deploys the implant with the simple release of a safety and press of the deployment button.
The PolyCor anchors that compose the implant are loaded in the distal end of the MIA-T delivery system. The PolyCor anchors are deployed into the tricuspid annulus in 4/1000ths of a second.
The MIA-T implant is composed of a series of PolyCor anchors and a proprietary suture lock that effects the bicuspidization of the tricuspid annulus, ultimately reducing annular dimensions and tricuspid regurgitation.
A series of catheters deploy the implant around the annulus. A proprietary lock secures the bicuspidization in place when the appropriate TR reduction is achieved as confirmed on imaging.