FDA Okays NeoChord’s Degenerative Mitral Valve Regurgitation Trial

NeoChord Inc. has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a prospective, multicenter, randomized clinical trial for its Artificial Chordae Delivery System, DS1000.
 
 “We are excited to begin our FDA approved pivotal trial at 20 U.S. mitral repair centers,” said Lori Adels, Ph.D., vice president of clinical, regulatory and quality at NeoChord. “This is the first U.S. clinical study of a trans-apical, beating heart procedure for replacement of ruptured or elongated chordae in patients with degenerative mitral valve regurgitation. The protocol was developed in consultation with the FDA and our principal investigators, David H. Adams, M.D., professor and chairman, Department of Cardiovascular Surgery, Icahn School of Medicine at Mt. Sinai, New York, and Michael A. Borger, M.D., Ph.D., professor and director, Cardiovascular Institute, New York Presbyterian/Columbia University Medical Center, New York, and is designed to establish the safety and efficacy of the DS1000 System as an alternative to standard surgical mitral valve repair.”
 
NeoChord received CE Marking approval for the DS1000 System in December 2012 and began marketing the product in the first quarter of 2013. The company plans to expand the commercial availability of the DS1000 System to additional European markets throughout 2016 and 2017.

Watch the video below to learn more about the DS1000:


 
“IDE approval is a major milestone for NeoChord and its investors,” said David Chung, president and CEO of NeoChord. “This technology has demonstrated excellent outcomes in reducing mitral regurgitation in both clinical studies and commercial use outside the U.S., and we expect to demonstrate the same excellent results in our U.S. pivotal study. We look forward to making this transformational technology available to patients in the U.S.”
 
The NeoChord DS1000 System is limited to investigational use only in the United States.
 
Based in St. Louis Park, Minn., NeoChord is a privately held developer of technology for the minimally invasive repair of degenerative mitral regurgitation (DMR), a progressive disease that can result in atrial fibrillation, congestive heart failure, and death when left untreated.