NeoChord said it won an investigational device exemption from the FDA for a clinical trial of its mitral valve repair technology.
St. Louis Park, Minn.-based NeoChord said the 20-site study is a prospective, multicenter, randomized clinical trial of its DS1000 artificial chordae delivery system.
“IDE approval is a major milestone for NeoChord and its investors,” president & CEO David Chung said in prepared remarks. “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.”
“We are excited to begin our FDA approved pivotal trial at 20 U.S. mitral repair centers,” added VP of clinical, regulatory & quality Lori Adels. “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, MD, Professor and Chairman, Department of Cardiovascular Surgery, Icahn School of Medicine at Mt. Sinai, New York, and Michael A. Borger, MD, PhD, 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.”
In June 2015, the company raised $12.6 million of a hoped-for $20 million debt round to support the DS1000 device, which is designed to allow the implantation of artificial chordae tendinae, thread-like connectors that anchor leaflets of the mitral valve to heart muscle. Doctors can use the device to repair mitral valve prolapse via a transapical, off-pump procedure.
Neochord won CE Mark approval in the European Union for the device in late 2012, but has not yet won FDA clearance of the device. The company reports that more than 100 patients across Europe have been treated with the device.