According to six-month data presented at EuroPCR (19–22 May, Paris, France), the Mitralign percutaneous annuloplasty system (MPAS) is associated with significantly improved valve function at six months. Mitralign now anticipates receiving CE marking for its device later this year.
According to a press release, a prospective, multicentre, single-arm study of MPAS met its safety endpoint at 30 days and its performance endpoint at six months.
In his presentation “Evaluation of the MPAS for the treatment of functional mitral regurgitation—six months results” at EuroPCR, Georg Nickenig of the University of Bonn, Germany, reported that the system was associated with a significant reduction in the anterior-posterior and septal-lateral dimensions of the annulus. He also noted that enhanced ventricular function was demonstrated by significant improvement in left ventricular end diastolic diameter and left ventricular end diastolic and systolic volumes. He said: “The data show statistically significant progress at six months, specifically in ventricular remodelling, which is one cause of symptoms. These encouraging data further support the use of percutaneous valve repair to treat this challenging patient population.”
Also at EuroPCR, Joachim Schofer (Medicare Center and Department for Percutaneous Interventions of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany) discussed his successful use of the MPAS to perform a direct transcatheter annuloplasty on special access patients with tricuspid regurgitation.
The press release reports that Mitralign is the only company to provide interventional cardiologists with a tool to perform minimally invasive, transcatheter procedures for both functional mitral regurgitation and tricuspid regurgitation. It adds that the company aims to treat tricuspid regurgitation using the same innovative technology as used with FMR, but with a modified delivery system. The MPAS is not approved for sale or distribution; however it is anticipated to receive CE marking in 2015.