CoreMedic Announces 2-Year-Data for Mitral Valve Chordal Repair Device ChordArt
Updated: Oct 20
November 4, 2021
Radolfzell, November 4, 2021. CoreMedic GmbH announces publication of 2-year follow-up results from the first in-human “CHAGALL” trial of its ChordArtTM 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 2 years follow up. The CHAGALL data was presented earlier this year at the 2021 Meeting of the American Association for Thoracic Surgery (AATS) by Professor Thierry Carrel, 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 finalize the development of the trans-septal catheter, that will allow a fully percutaneous delivery of the ChordArtTM implant to repair the mitral valve (TMVr). The transcatheter system is planned to enter a clinical evaluation soon.”
The ChordArtTM device is being developed as a first line treatment option for mitral valve regurgitation (MR). 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.
Dr. Alberto Weber, Co-Founder and Chief Medical Officer of CoreMedic GmbH, said: “According to the principles of the Mitral Valve Academic Research Consortium, the results of the ChordArtTM 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 October 29, 2021 (Journal Pre-proof) by The Journal of Thoracic and Cardiovascular Surgery.
About CHAGALL: Mitral valve regurgitation (MR) is a condition in which the mitral valve leaflets fail to close properly, allowing significant backflow of blood from the left ventricle into the left atrium during systole. Valve disease prevalence rises dramatically with age, reaching epidemic levels in the elderly.MR is the most common valve pathology in the US. Over 7 million people suffer from the disease and each year 250,000 patients are diagnosed with MR. If untreated, MR can cause shortness of breath, decreased cardiac output, intolerance to physical exercise, congestive heart failure and death.The standard-of-care in surgically treating degenerative MR involves replacing ruptured or elongated valve chordae with artificial implants to restore the function of the valve.Implanting the standard artificial chordae requires complex and long procedural steps. This complexity is associated with risks including failure of the valve repair or the need to repeat the operation, the use of a cardiac bypass machine and stopping the heart.
About CoreMedic:CoreMedic GmbH is a development-stage cardiology company, located in Radolfzell, Germany. As a spin-off of the Heart Center of University of Bern, Switzerland, CoreMedic was initiated in 2012 to develop the breakthrough treatment concept for mitral valve regurgitation ChordArtTM. The company is backed by a group of experienced and committed private investors and institutional healthcare investor SHS (www.shs-capital.eu).
About ChordArtTM:The ChordArt Transcatheter Mitral Valve repair (TMVr) system is designed to improve chorda repair procedures across all crucial parameters. These include the reduction of patient trauma, duration of procedure and complexity as well as operator dependency and time of recovery for the patient. ChordArtTM is designed to deliver implants via transcatheter to allow for intervention in high-risk as well as asymptomatic patients, which are not eligible for treatment with the current "Gold Standard" of chorda replacement via open-heart surgery.
For further information, please visit www.coremedic.de or feel free to
contact us via info@coremedic.de or under +49 (0)7732 894 610.
PR Contact:
Thomas BauerCEO/ General ManagerCoreMedic
Fritz-Reichle-Ring 2
78315 Radolfzell
GERMANY
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