US-based cardiac device company Mitralign has completed patient enrollment in its European study investigating the novel catheter-based valve repair device in patients with functional mitral regurgitation.
Mitralign will seek CE Mark approval in the EU for the catheter-based valve repair technology based on the successful outcomes from the study.
The Mitralign system has been designed for the first-line percutaneous treatment of functional mitral regurgitation. The system delivers a series of surgical implants directly into the mitral annulus through a catheter and emulates surgical annuloplasty, or the surgical repair of leaking mitral valves.
The device uses a system of wires and catheters to implant at least one pair of polyester anchors within the mitral annulus, a ring of tissue surrounding the mitral valve.
The anchors are then cinched together, thereby reducing the circumference of the mitral valve towards its normal size with a goal to improve heart function and assist in the alleviation of heart failure symptoms.
Mitralign CEO Rick Geoffrion noted this is an important milestone for the company and brings its Mitralign system that much closer to patients who suffer this severe heart disease.
"We have completed the enrollment of 61 FMR patients in Europe, and we are in the process of collecting the necessary follow-up data for submission to our notified body in Europe for CE Mark approval.
"In the meantime, we will continue to enroll patients within our active clinical studies in order to accrue additional data for the medical community. We expect to report results from this trial before the end of 2014," Geoffrion added.