It’s been EuroPCR in Paris this week, the main event for practitioners of percutaneous cardiac therapies. Valve repair company Mitralign has shared six month data on its Mitralign Percutaneous Annuloplasty System (MPAS) for treatment of functional mitral regurgitation (FMR), as presented at the event.
Mitralign Inc. lays claim to possessing the only direct transcatheter annuloplasty system designed to treat both functional mitral regurgitation and functional tricuspid regurgitation.
In its newly presented prospective, multi-center, single arm study met its safety endpoint at 30 days and its performance endpoint at six months. In the clinical study, the MPAS demonstrated a statistically significant reduction in left ventricular diameter, significant reduction of both the A-P and S-L annular dimensions and a significant improvement of the patient’s walking distance.
In his presentation, “Evaluation of the Mitralign Percutaneous Annuloplasty System for the treatment of FMR 6 month results” Prof. Georg Nickenig of the University of Bonn, showed that the system demonstrated a significant reduction in the anterior-posterior, A-P, and septal-lateral, S-L, dimensions of the annulus. Enhanced ventricular function was demonstrated by significant improvement in left ventricular end diastolic diameter and left ventricular end diastolic and systolic volumes.
The Mitralign Percutaneous Annuloplasty System is not yet approved for sale or distribution, but is anticipated to receive CE marking in 2015.
“The data show statistically significant progress at six months, specifically in ventricular remodeling which is one cause of patient symptoms,” said Dr Nickenig. “These encouraging data further support the use of percutaneous valve repair to treat this challenging patient population.”
“It is noteworthy that the Mitralign system has demonstrated safety and performance in a very challenging FMR patient population,” commented Rick Geoffrion, chief executive officer of Mitralign. “The patients were all on optimal medical therapy and had an average ejection fraction of 33%. Such data illustrate the value this system brings to those patients dealing with FMR.”
Source: Business Wire