Enrollment Completed in EU Study of Mitralign System for Functional Mitral Regurgitation

April 8, 2014—Mitralign, Inc. (Tewksbury, MA) announced that it has completed enrollment in a European study investigating the Mitralign system to treat functional mitral regurgitation (MR). Pending successful outcomes from the study, the company will seek CE Mark approval in the European Union as a first step toward commercializing the Mitralign system.

According to the company, 61 functional MR patients have been enrolled. Investigators are collecting the necessary follow-up data for submission to the notified body in Europe for CE Mark approval. The company will also continue to enroll patients within its active clinical studies in order to accrue additional data. Mitralign expects to report results from this trial before the end of 2014.

The study’s lead investigator is Georg Nickenig, MD, Professor at the Universitätsklinikum Bonn in Germany. In Mitralign’s press release, Prof. Nickenig commented, “Patients with functional MR are very sick and often experience a dilation of the heart and the deterioration of heart function, despite optimal medical therapy. It is our hope that this novel device will provide a therapeutic option for these patients and improve their quality of life.” 

The Mitralign system utilizes a system of wires and catheters to implant at least one pair of polyester anchors within the mitral annulus. The anchors are then cinched together, reducing the circumference of the mitral valve toward its normal size to improve heart function and assist in the alleviation of heart failure symptoms, stated the company.