MitralClip

Problem

Transcatheter mitral valve implantation or replacement (TMVR) is a new technique for the treatment of mitral regurgitation (MR) and/or stenosis in patients with prior mitral valve surgery (ring annuloplasty or surgical bioprosthesis), in native mitral regurgitation due to mitral annular calcification, and in native MR with dedicated (investigational) transcatheter prostheses. One of the complications of this procedure (see attached reference) is the potential to displace the anterior mitral leaflet further into the left ventricular outflow tract (LVOT) creating systolic LVOT obstruction (LVOTO).

Post-TMVR LVOTO

Solution

A number of potential solutions to this problem have been developed, including the use of a balloon or stent placed in the LVOT and a complex procedure (“Harpoon”) to slice the leaflet in halves using a radiofrequency wire placed transseptally around it. Our device, the MitralClip, prevents the anterior leaflet from obstructing the left ventricular outflow tract to the aorta by entering through the same incision as the catheter used in TMVR and suturing the anterior leaflet to the new mitral valve using shape memory nitinol technology. This procedure will be deployed immediately after valve placement if patients are deemed to be high risk for LVOTO before or during surgery.

Depiction of our solution

Future Work

We are currently developing a refined prototype through further in vitro testing and in the process of filing for intellectual property. We are next looking to further generalize our design as a suture clip that can be used in a variety of transcatheter procedures.