NeoChord of Eden Prairie, MN received European regulatory approval for the company’s DS1000 mitral valve prolapse repair system only a couple of months after unveiling it publicly. The technology allows for minimally invasive implantation of artificial chordae tendinae without having to go on bypass.
Because ribs don’t have to be broken nor is external ventilation employed, the procedure should be significantly easier on fragile patients not suitable for traditional approaches.
From the announcement:
The Company also announced that it has started the 50-patient ‘TACT’ (Transapical Artificial
Chordae Tendinae) Registry, 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).
“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.”
(hat tip: MassDevice)