Clinical Trial in India & Europe for Mitral Regurgitation Device
Published date : 16 January 2013
Article date : 16 January 2013
Redorbit reports on a press release from Phoenix Cardiac Devices which announces the start of a clinical trial in India and Europe that will test their BACE device for the treatment of mitral regurgitation without open heart surgery. Apparently, the manufacturer has enrolled its first patient in a clinical trial aimed at achieving CE Mark approval in Europe.
They say the the trial will assess the safety and efficacy of the BACE device which is an adjustable tension band that encircles the heart and supports the mitral valve leaflets so they close properly to prevent the back flow of blood into the heart.
Previous studies of BACE, including a proof of concept study in 12 patients and a feasibility study in 14 patients, demonstrated a significant reduction in mitral regurgitation and no device-related serious adverse events following implantation. Results of the proof of concept study were published in the Australian journal, Heart, Lung and Circulation in December, 2009. The current study will enroll 60 patients in India and Europe who have moderate to severe functional mitral regurgitation.
The BACE can be remotely adjusted from an external port and its efficacy can be assessed through real-time echocardiography whih allow immediate adjustments in tension and pressure.
Source: Redorbit.com, 14 January 2013.
