CoreMedic has announced the publication of two-year follow-up results from the first in-human CHAGALL trial of its ChordArt mitral valve repair device in the treatment of mitral valve regurgitation (MR). Chordal replacement with ChordArtTM is reported to be safe, effective, and durable at two years follow up.
The CHAGALL data was presented earlier this year at the American Association for Thoracic Surgery 101st Annual Meeting (AATS 2021, 30 April–2 May, virtual) by Thierry Carrel (University Hospital Zürich, Zürich, Switzerland), corresponding author of the study.
Thomas Bauer, CEO of CoreMedic GmbH, stated: “This is important news that confirms our approach. The data shows that the implant is safe and reliably functions over a longer period. We have not seen any elongation or rupture of the artificial chords and no displacement or fracture of the anchors has been reported. The whole team is now focusing to finalise the development of the transseptal catheter, that will allow a fully percutaneous delivery of the ChordArt implant to repair the mitral valve (TMVR). The transcatheter system is planned to enter a clinical evaluation soon.”
The ChordArt device is being developed as a first line treatment option for mitral valve regurgitation. MR is the most common heart valve disease and a growing medical burden, particularly in ageing societies, and affects more than 25 million patients worldwide. The device is designed to enable safe and effective repair of the mitral valve by replacing damaged mitral valve chords with a physiological approach respecting the natural anatomy. Due to its minimal footprint, the implant keeps the door open for possible future therapy needs, CoreMedic said in a press relase.
Alberto Weber, co-founder and chief medical officer of CoreMedic, said: “According to the principles of the Mitral Valve Academic Research Consortium, the results of the ChordArt implant meet our highest expectations, particularly in terms of efficacy and safety. The performance of this small implant confirms that we are on the verge of a revolution. We are convinced that our innovative technology has the potential to disrupt the treatment of degenerative mitral regurgitation.”
The article “Mitral valve repair with a device for artificial chordal implantation at 2 years” was published on 29 October by The Journal of Thoracic and Cardiovascular Surgery.