Neochord DS1000 System Successfully Treats 20th Patient in Combination with Other Beating Heart Procedures
- Nearly 1,000 patients treated with the DS1000 System
- Reports acceleration in two transcatheter mitral repair programs
ST. LOUIS PARK, Minn., April 30, 2018 (GLOBE NEWSWIRE) -- NeoChord, Inc., a privately-held medical technology company leading the advancement of beating heart mitral valve repair for degenerative mitral regurgitation (DMR), today announced that it has successfully treated 20 patients using the NeoChord chordal repair procedure in combination with other beating heart procedures, using a “Mitral Toolbox” approach.
“These successful outcomes are a promising sign that a combination approach may expand the treatment options available to patients with complex forms of mitral valve disease and who are at high risk for traditional cardiac surgery,” stated David Chung, NeoChord President and CEO. “Our DS1000 System continues to demonstrate excellent outcomes in reducing mitral regurgitation in our pivotal clinical trial for FDA approval and in commercial use outside the US with nearly 1,000 patients treated to date. In addition to our transapical program, we are collaborating with our interventional cardiology advisors to accelerate the development of multiple transcatheter programs focused on chordal repair and mitral valve leaflet coaptation approaches to expand our technology to an even greater patient population.”
The NeoChord procedure has been performed as part of a “Mitral Toolbox” approach, in combination with beating heart procedures including, the Abbott MITRACLIP, Cardiac Dimensions’ CARILLON, Valtech’s AMEND, and the Edwards Lifesciences’ CARDIOBAND.
The company also announced that it will enroll patients requiring beating heart mitral valve repair with combination procedures in a prospective, post-market registry (the ACCHORD Study) and follow patients for up to two-years. Ralph Stephan von Bardeleben, MD, Director, Structural Heart and Valve Interventions, University of Medicine, Mainz, Germany and Prof. Hendrik Treede, Director of the Department of Cardiac Surgery at the Mid-German Heart Center, University Hospital, Halle (Saale), Germany have been named as the study’s primary investigators.
“The ability to place artificial chords in prolapsed and flail segments of the anterior and posterior mitral leaflet is an extremely appealing aspect of the NeoChord procedure and serves as the perfect complement to other beating heart annular and leaflet repair approaches,” stated Dr. von Bardeleben. “Early outcomes in our series of patients undergoing combined therapy treatments have been very encouraging. I look forward to continuing to evaluate this promising therapeutic approach through the ACCHORD Study.”
Degenerative Mitral Valve Regurgitation (DMR)
DMR is the third most common cardiovascular disease in both the US and Europe with over 42 million people afflicted in the US each year. It is a progressive disease that can result in atrial fibrillation, congestive heart failure, and death when left untreated. Most cases of DMR are treated with surgery, where patients undergo mitral valve repair.
Mitral Valve Repair with NeoChord DS 1000 System
NeoChord offers a transapical beating heart option for treating mitral valve disease and restoring mitral valve function on a beating heart using the NeoChord DS1000 system. The NeoChord procedure is a mitral valve chordal repair technique that is performed on a beating heart via a thoracotomy. Nearly 1,000 patients have been treated with the NeoChord procedure to date.
About NeoChord, Inc.
Founded in 2007 and based in St. Louis Park, Minnesota, NeoChord, Inc. is a privately held medical technology company leading the advancement of beating heart mitral valve repair for DMR. NeoChord’s DS1000 system received CE market clearance in December 2012. NeoChord received IDE approval from the FDA for the US pivotal trial in May 2016. For more information, please visit the Company's website at www.neochord.com.
CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use. The NeoChord DS1000 has CE-market clearance.
NEOCHORD, DS1000, RECHORD, NEOCHORD CONSULTCONNECT, ACCHORD, the stylized logos, and Transforming Mitral Valve Repair are registered trademarks or service marks of NeoChord, Inc. Copyright © 2018 NeoChord, Inc.
Contact
Bruce Van Deman
NeoChord, Inc.
(952) 698-7812 or (949) 413-1301
bvandeman@neochord.com