Back to Program

The concept of suture annuloplasty dates back to a surgical suture-based technique developed by Burr and Paneth in the late 1870s, and still used by some surgeons. The concept of duplicating this procedure via a percutaneous retrograde approach was first conceived by Dr. Paul Spence, and is now being extended and refined into a clinical tool by Mitralign, an early stage company in Salem NH founded in mid 2004 and affiliated with the Accelerated Technologies, Inc. medical device incubator).

The procedure involves placement of a coronary sinus catheter on which 2 opposing (i.e., N-N) permanent magnets are mounted and positioning the magnets behind the middle of P2. A left ventricular catheter with a S magnetic tip is advanced retrograde from the femoral artery, prolapsed across the aortic valve, and inched up the lateral wall of the left ventricle. In doing so, it passes between the 2 papillary muscle bellies, and then behind the posterior leaflet, to come to rest against the underside of the mitral annulus at P2. This location is confirmed and secured by establishing magnetic 'lock-up' between the LV and CS magnets. The LV catheter is then used to drive a special guidewire through the annulus and into the left atrium, following which the LV catheter is removed and replaced with a guiding catheter. Specialized devices are then used to translate medially and laterally along the annulus relative to the index wire located at P2, and to place a total of 2 to 4 additional wires through the annulus spanning the P1, P2 and P-3 zones. Catheters are then inserted through the left ventricular guiding catheter over these trans-annular guidewires, to deliver specialized 'anchors' that lie across the annular tissue. These anchors are then plicated together and locked into position to produce similar 2-3 cm reduction in posterior annular circumference and 0.5-1.0 reduction in septal-lateral dimension to that seen with surgical annuloplasty.

In the 18 months since this company was founded, it has developed prototypes capable of executing each of the steps of the procedure as described above, demonstrated in extensive percutaneous and open surgical porcine experiments. By the end of 2005, it is anticipated that the overall system will be refined and perfected to the level required for First In Man testing. In summary, the Mitralign transventricular direct annular plication approach seems technically feasible, and capable of providing a similar degree of anatomic correction as the suture-based surgical procedure on which it was modeled.