PRESS RELEASE: COREMEDIC ANNOUNCES 2-YEAR-DATA FOR MITRAL VALVE CHORDAL REPAIR DEVICE CHORDART
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.
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 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).
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
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PUBLICATION: AUTOMATED IMPLANTATION OF ARTIFICIAL MITRAL CHORDS: PRELIMINARY RESULTS FROM FEASIBILITY TRAIL
April 1, 2020
Radolfzell, April 1, 2020: CoreMedic GmbH announces publication of the results of a successful first-in-man trial of its mitral valve chordal repair system ChordArt.
Purpose of the Study
A novel chordal system enables automated implantation of artificial mitral chords to treat mitral regurgitation (MR). This article summarizes the first-in-man initial clinical results.
The CHAGALL (CHordArt system study for the treatment of mitral reGurgitAtion due to leaflet proLapse or fLail) trial is a single arm, multicenter, prospective study to test the feasibility of this system for mitral repair. The interim clinical and echocardiographic results of the first 5 patients with a 12-month follow-up are presented.
Five patients (mean age, 64 years) with severe MR received implantation of neochords with this device under cardiopulmonary bypass. Technical success was obtained in all patients. Transesophageal echocardiogram showed either no or trace residual MR (<1+/4+) after repair. Survival at 30 days was 100%, and no device-related complication occurred. Reduction of MR was sustained up to 12 months.
This novel chordal system is promising because it greatly facilitates the deployment of neochords to repair the mitral valve. Results at 12 months are encouraging. The device is currently under development for transcatheter approach.
For further information, see the full text publication https://www.annalsthoracicsurgery.org/article/S0003-4975(19)31425-0/fulltext
COREMEDIC ANNOUNCES FIRST CLINICAL USE OF MITRAL VALVE CHORDAL REPAIR SYSTEM CHORDART™
May 16, 2018
Radolfzell, August 1, 2018: German medtech developer CoreMedic GmbH this week announced the launch of a first-in-man trial of its ChordArt mitral valve repair device, touting the trial as the first of its kind to treat patients with ruptured or elongated mitral chords.
The company’s ChordArt implant is designed to replace ruptured or elongated mitral chordae and to re-establish the connection of the valve leaflets with the papillary muscle to restore functionality. In the trial, researchers will explore the use of the system in up to 40 patients at six European centers, CoreMedic said.
“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,” CEO Thomas Bauer said in a press release.
“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,” SHS managing partner Hubertus Leonhardt said in a prepared statement.
The first patient in the trial has already been treated by Dr. Kęstutis Ručinskas at Lithuania’s Vilnius University Hospital. The patient has reportedly recovered “very well” from the intervention and has shown no signs of complications at a 30-day follow-up.
“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. Thanks to the ease of the ChordArt deployment technique, this was the fastest mitral valve chordal repair I have ever witnessed,” Dr. Alberto Weber of Zurich, Switzerland, who proctored the procedure, said in a press release.
Further information, visit www.coremedic.de
SHS INVESTS IN INNOVATIVE HEART VALVE-REPAIR START-UP COREMEDIC
August 1, 2017
Tuebingen, 1 August 2017. SHS Gesellschaft für Beteiligungsmanagement is investing in CoreMedic, a start-up developing innovative, transfemoral repair systems to treat heart valve malfunctions. SHS is investing from its fourth fund generation to finance CoreMedic's further growth and the clinical application of its innovative products.
Mitral heart valve regurgitation (MR) is one of the most common reasons for cardiac failure. The current gold standard therapy is surgical repair by open heart surgery at the arrested heart. CoreMedic is developing ChordArt(TM), a novel heart valve repair system that is less invasive, easy to use and most importantly, will result in an excellent outcome for the patient. This therapy will allow the treatment of millions of patients suffering from this disease.
The goal of CoreMedic's novel medical device is to improve the treatment for patients with mitral heart valve regurgitation. With its minimally invasive approach, ChordArt(TM) allows the treatment of patients that are currently excluded from the therapy due to the invasiveness of today's gold standard, the surgical repair.
CoreMedic will use the raised capital to further develop its ChordArt(TM) technologies. A first in human clinical use will be advanced for 2018 as well as the initiation of a clinical trial that will support the European approval (CE) of the product.
"Our novel ChordArt(TM) repair concept offers tremendous advantages compared to the currently applied open heart surgery at arrested heart. Due to the significantly reduced invasiveness, the ChordArt(TM) approach has not only the potential to allow treatment of currently untreatable patients. It can also reduce the trauma of patients that undergo treatment with today's gold standard substantially", says Thomas Bauer, CEO of CoreMedic.
"The implant to repair the malfunction of the mitral valve has a minimal footprint and is truly respecting the natural anatomy of the heart. Therefore it is not 'burning any bridges' for follow-up treatments that might be required later and is leaving the physician and the patients options that no other device is offering right now", he continues.
Hubertus Leonhardt, Managing Partner at SHS comments: "Proven results of pre-clinical studies have shown that CoreMedic's ChordArt(TM) incorporates the potential to have an enormous impact on the treatment of structural heart diseases. We are looking forward to supporting CoreMedic on their path to demonstrate the superiority of the ChordArt(TM) system in clinical application and to further develop this novel device. We can provide CoreMedic both capital and our industry expertise with an extensive network and over 20 years of experience in the medical technology and life-science sector."
With a total volume of 125 million euro, the fourth SHS fund is focusing on expansion financing, changes in shareholder structures and successor situations. The Tuebingen based investor is planning further acquisitions and investments in the fast-growing medical technology and life-science industries in Germany, Austria and Switzerland in the months ahead.
CoreMedic has been founded in 2012 in Bern, Switzerland and is a privately help medical device company with locations in Biel, Switzerland and Tuebingen, Germany.
CoreMedic emerged out of the clinical environment directly addressing unmet clinical needs of physicians and surgeons.
CoreMedic is focusing on the development of devices and therapies to address the treatment of heart valve diseases which is representing a multi-billion dollar market globally.
CoreMedic's ChordArt(TM) mitral valve repair system is focusing on the minimally invasive, trans-femoral repair at the beating heart.
CoreMedic consists of a team of skilled and dedicated professionals with a diverse background in medical application (surgeons and cardiologists), management, research and development, regulatory and quality assurance. The team has a proven track record setting up and managing innovative medical device companies, and has developed an extensive network of contacts over many years including internationally renowned surgeons, physicians and opinion leaders in the field of cardiovascular therapies.
CoreMedic is EN ISO 13485:2016 certified.
Further information, visit www.coremedic.de
ChordArt in scientific papers
“Mitral valve repair with a device for artificial chordal implantation at 2 years”
JTCVS OPEN, OCT 2021, DOI https://doi.org/10.1016/j.xjon.2021.08.041
"Automated Implantation of Artificial Mitral Chords: Preliminary Results From the Feasibility Trial"
Ann Thorac Surg 2020 Feb;109(2):597-602.
Chorda Repair (TMVr)
"Transcatheter mitral valve repair: review of current techniques"
Indian J Thorac Cardiovasc Surg 2020 Jan;36(Suppl 1):53-63
Chorda Repair (TMVr)
"Transseptal chordal replacement: early experience"
Ann Cardiothorac Surg 2021 Jan;10(1):50-56