In short
Mitral valve repair specialist company NeoChord, has received CE-marking for its technology that allows the implantation of artificial chordae tendinae, a proven technique for the repair of mitral valve prolapse, via a transapical, off-pump procedure.
Background
NeoChord received CE marking in Dec. 2012 for the DS1000 device for minimally invasive mitral valve repair via surgical implantation of artificial chordae tendinae. Degenerative mitral regurgitation occurs when the leaflets of the heart’s mitral valve do not close properly, usually due to rupture or elongation of the chordae tendinae (chords) that control the leaflets’ motion. During pumping, the “leak” in the mitral valve causes blood to flow backwards (mitral regurgitation) into the left atrium, thereby decreasing effective blood flow to the body.
NeoChord has also announced that it has started a 50-patient ‘TACT’ (Transapical Artificial Chordae Tendinae) Registry, which will kick off formally with first commercial European procedures scheduled for Q1 2013. Initial TACT Registry procedures will be proctored by Dr. Joerg Seeburger (Leipzig Herzzentrum), Dr. Giovanni Speziali (University of Pittsburgh Medical Center) and Dr. Richard Daly (Mayo Clinic).
Regulatory status
The NeoChord DS1000 System is CE marked and approved for sale in Europe, but is not available for commercial use in the United States.
Source: Neochord, Business Wire
published: January 7, 2013 in: Approval/Clearance, Cardio, Techniques