CE Mark For NeoChord’s DS1000 Mitral Valve Repair Device

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.


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).

Physician/Inventor comments
“Receiving CE marking for the NeoChord device for implantation of artificial chordae tendinae via a transapical, off-pump procedure and beginning the Tact Registry are meaningful steps forward in the treatment of patients with severe mitral regurgitation,” said Dr. Giovanni Speziali, the primary inventor of NeoChord’s technology. “We are pleased with the short- and medium-term clinical outcomes to date using NeoChord’s technology to treat patients suffering from mitral regurgitation. The NeoChord procedure allows patients an alternative to still undergo a quality repair without enduring the rigors of traditional treatment via open-chest surgery performed on a stopped heart.”

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