16 May 2018. Privately-held CoreMedic announces the start of a first-in-man “Chagall” study to evaluate new minimally-invasive valve repair technology.
CoreMedic is developing ChordArt, a novel transfemoral chordal repair system to address unmet needs in the treatment of degenerative heart disease with mitral valve insufficiency, the most common valve pathology affecting more than 7 million patients worldwide. The ChordArt implant is used to replace the ruptured or elongated chordae of the valve and re-establishes the connection of the valve leaflets with the papillary muscle to restore the proper function. As ChordArt reduces the complexity of the procedure, both patients and physicians will benefit.
The “Chagall” Trial is a prospective, multicenter, first-in-man study intended to establish the safety and effectiveness of the ChordArt System. The study was approved to enroll up to 40 subjects at up to 6 European centers. This study is the first trial of its kind to treat patients that have ruptured or elongated mi-tral chords with the ChordArt System.
The first-in-man (FIM) case using ChordArt was treated by the Heart Team led by Prof. Kstutis Ručinskas at the Vilnius Uni-versity Hospital, Lithuania. The ChordArt treatment was aimed at improving procedural outcomes and allowing standardized placement of the artificial chords with a dedicated, reproducible technique.
The patient recovered very well from the intervention and is continuously doing well. A 30 day follow-up showed no complications.
“Using the ChordArt reduced the invasiveness and duration of the procedure by repairing the valve in a fast, precise and safe way. This allowed the Heart Team to focus on the procedure and timing rather than manually placing the artificial chords to resolve the mitral insufficiency” said Dr. Alberto Weber, Her-zzentrum Hirslanden, Zurich, Switzerland, who proctored the procedure. “Thanks to the ease of the ChordArt deployment technique, this was the fastest mitral valve chordal repair I have ever witnessed.”
For Thomas Bauer, CEO of CoreMedic, “The first clinical use of ChordArt is a major milestone in our path towards developing the best in class transfemoral mitral valve chordal repair system”. Hubertus Leonhardt, Managing Partner of medical device investor SHS, commented: “In 2017 we invested in CoreMedic to advance the development of ChordArt. We look forward to the results of clinical trials that will validate the applications of this breakthrough device.”
About Mitral Regurgitation:
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.
CoreMedic is dedicated to develop devices and therapies to dramatically improve the quality of life of patients with heart valve diseases, a primary challenge in global healthcare.
CoreMedic”s flagship product ChordArt is a transfemoral system for mitral valve chordal repair in the beating heart. ChordArt™ offers a first line therapy option for patients with mitral valve dysfunction and represents a less invasive procedure compared to the current surgical methods with open-chest or trans-apical access. ChordArt is designed to allow mitral repair in a wider patient population. ChordArt™ is currently under clinical evaluation in European clinics.
CoreMedic is a privately held medical device company headquartered in Radolfzell, Germany with a subsidiary in Biel/Bienne, Switzerland. CoreMedic is EN ISO 13485 certified.
The investor base consists of founders, private investors and medical device investor SHS Gesellschaft für Beteiligungsmanagement mbH ( www.shs-capital.eu).
For further information, please visit www.coremedic.ch
Dr. Reinhard Saller