News | Heart Valve Technology | May 17, 2016

NeoChord Receives FDA Approval to Begin Clinical Trial of DS1000 System

Pivotal study will enroll up to 450 patients in a randomized trial of Artificial Chordae Delivery System for treatment of degenerative mitral valve regurgitation

NeoChord, DS1000 System, FDA approval, U.S. pivotal trial

May 17, 2016 — NeoChord Inc. announced it 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.

The pivotal trial will be conducted at 20 U.S. mitral repair centers, according to Lori Adels, Ph.D., vice president of clinical, regulatory and quality at NeoChord. Adels said it is the first U.S. clinical study of a transapical, beating heart procedure for replacement of ruptured or elongated chordae in patients with degenerative mitral valve regurgitation.

Trial protocol was developed in consultation with the FDA and principal investigators David H. Adams, M.D, professor and chairman, Department of Cardiovascular Surgery, Icahn School of Medicine at Mt. Sinia, New York; and Michael A. Borger, M.D., Ph.D., professor and director, Cardiovascular Institute, New York Presbyterian/Columbia University Medical Center, New York. The trial 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 Q1 2013. The company plans to expand the commercial availability of the DS1000 System to additional European markets throughout 2016 and 2017.

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