NeoChord Receives CE Marking for DS1000 Mitral Valve Repair Device and Plans First Enrollments in TACT Registry for Q1 2013.
TACT Trial results, recently reported at TCT and EACTS, show good safety and efficacy for NeoChord's sternal-sparing, beating-heart procedure to implant artificial chordae tendinae.
"With regulatory approval in Europe and the TACT Registry in place, NeoChord is positioned to be a leader in the emerging field of mitral repair." John Seaberg, Chairman and CEO, NeoChord
EDEN PRAIRIE, Minn. -- NeoChord, a medical device company focused on minimally invasive mitral valve repair, announced today that it 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.
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."
About NeoChord, Inc.
Based in Eden Prairie, Minn., NeoChord is a privately held medical technology company focused on advancing the treatment of mitral regurgitation. The Company 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 blood flow to the body. Mitral regurgitation is a progressive disease that left untreated can result in atrial fibrillation, congestive heart failure, and death. For more information, visit: www.NeoChord.com.
The NeoChord DS1000 System is CE marked and approved for sale in Europe.
Caution: In the United States, the NeoChord device is not available for commercial use.
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|Date:||Jan 3, 2013|
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