Medical device firm NeoChord has secured investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to start a clinical study for its DS1000 artificial chordae delivery system.
DS1000 has been developed to treat degenerative mitral valve regurgitation (DMR), which is a progressive disease that can result in atrial fibrillation, congestive heart failure, and death when left untreated.
The prospective and randomized clinical trial will be carried out at 20 US mitral repair centers, according to NeoChord clinical, regulatory and quality vice president Dr Lori Adels.
NeoChord president and CEO David Chung said: "This technology has demonstrated excellent outcomes in reducing mitral regurgitation in both clinical studies and commercial use outside the US, 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 US."
In December 2012, the firm obtained CE mark approval for the DS1000 system to treat DMR without the use of cardiopulmonary bypass.
The company intends to expand the commercial availability of the DS1000 system to additional European markets throughout this year and 2017.