NeoChord Completes Enrollment for ‘TACT’ Clinical Trial
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Sep 10, 2012--: “The 30-patient TACT trial now has numerous patients showing one and even two year durability of repair with clinically significant reductions in mitral regurgitation. Acute procedure success tares in the second half of the trial were 94% with excellent early durability results. These combined results suggest that NeoChord will make a strong contribution in the evolving field of mitral repair.” John Seaberg, Chairman and CEO, NeoChord , a medical device company focused on minimally invasive mitral valve repair, announced today that it has completed enrollment for its ongoing ‘TACT’ (Transapical Artificial Chordae Tendinae) clinical trial in Europe.
“We are very pleased that we have successfully concluded enrollment into our TACT trial, as these patients suffering from mitral regurgitation are potentially avoiding the complications and trauma associated with traditional open-chest surgery performed on a stopped heart,” said John Zentgraf, vice president of research and development at NeoChord. “We look forward to conducting additional studies via the TACT Registry in Europe commencing in early 2013.” “Follow-up visits at 12 and 24 months post-op confirm that the vast majority of patients operated on using the NeoChord technology continue to show resolution or significant reduction of mitral regurgitation up to two years after the procedure,” added Giovanni Speziali, M.D., a cardiac surgeon who is the primary inventor of the NeoChord device. “These results compare favorably to those obtained with traditional surgical repair of severe mitral regurgitation,” said Dr. Speziali. “I am very pleased with the progress we have made in both patient selection and procedure methodology.” The NeoChord procedure was developed to treat mitral prolapse caused by ruptured or elongated chordae tendinae — the primary cause of degenerative mitral regurgitation –— via minimally invasive implantation of artificial chordae tendineae. The technology was developed by Dr. Speziali, University of Pittsburgh Medical Center, along with Richard Daly, M.D., a cardiac surgeon form Mayo Clinic, and Charles Bruce, M.D., a cardiologist also of Mayo Clinic. The technology is licensed exclusively to NeoChord Inc.
About NeoChord Inc. Based in Eden Prairie, Minn., NeoChord is a privately held medical technology focused on advancing the treatment of mitral regurgitation. The Company expects to commercialize a surgical 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 leaflet’s 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.
Caution: The NeoChord device is an investigational device and is not available for commercial use.
700214-001Rev 1CONTACT: Ronald Trahan Associates Ronald Trahan, APR, +1-508-359-4005, x108 KEYWORD: UNITED STATES EUROPE NORTH AMERICA MINNESOTA INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CARDIOLOGY CLINICAL TRIALS MEDICAL DEVICES SOURCE: NeoChord Copyright Business Wire 2012 PUB: 09/10/2012 09:49 AM/DISC: 09/10/2012 09:49 AM http://www.businesswire.com/news/home/20120910006088/