PRESS RELEASE: COREMEDIC ANNOUNCES SUCCESSFUL TRANSCATHETER APPLICATION OF MITRAL VALVE CHORDAL REPAIR DEVICE CHORDART
November 8, 2023
Radolfzell, November 8, 2023. CoreMedic GmbH announces the world's first successful transcatheter application of the ChordArt technology for mitral valve repair. The patient, who suffered from severe degenerative mitral regurgitation due to mitral leaflet flail, was successfully treated as part of CoreMedic’s First-in-Human trial for percutaneous mitral chordae tendineae replacement with the ChordArt TMVr-System. This has the potential to fundamentally change the treatment of Primary Mitral Regurgitation, a severe disease that effects millions of people around the world.
Josef Bogenschütz, CEO of CoreMedic GmbH stated: “We are thrilled to achieve this historic milestone with our revolutionary ChordArt TMVr-System, a novel approach for percutaneous mitral valve repair. Thank you to all who played a crucial role in making this success true. This achievement is a testament to the dedication and hard work of our exceptional team, and we are deeply appreciative of their contributions. Our cutting-edge solution enables us to position ourselves as leaders in the field of catheter based mitral valve repair. We are committed to redefining the gold standard, thereby setting new benchmarks for excellence in the future”.
Thomas Bauer, CTO and co-founder of CoreMedic GmbH, stated: “We are very happy for the patient and are delighted about the technical success as well. Results from the 5-year follow-up of our initial surgical study with the ChordArt-System have been exceptionally promising. Now we have demonstrated the ability to percutaneously deliver this implant less invasively, via the transfemoral, transseptal route – an outstanding achievement, which the whole cross-functional team is extremely proud of.”
The ChordArt device is being developed as catheter-based first line treatment option for Primary Mitral Regurgitation (PMR). PMR is one of the most common heart valve diseases and a growing medical burden, particularly in aging societies, affecting 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.
Prof. Alberto Weber, Founder and Chief Medical Officer of CoreMedic GmbH, announced: “Percutaneous, transseptal mitral valve repair of flail leaflets is now a reality. A safe and reproducible solution that invites an end to watchful waiting in patients with severe degenerative mitral regurgitation. My special thanks to the professionals who made this patient happy: Prof. Maurizio Taramasso, Prof. Michel Zuber and Leonora Zuberi from our Swiss team as well as Prof. Kęstutis Ručinskas, Dr. Diana Zakarkaitė, Dr. Andrej Podkopajev, Dr. Vilnius Janušauskas and Prof. Giedrius Davidavičius at the University Hospital in Vilnius, Santaros Klinikos, Lithuania.”
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 critical dimensions in the elderly societies that are known to be aging.
MR is the most common valve pathology in Europe an US with a prevalence of 2% across the population and >10% in persons aged 75+ years. 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 (PMR) involves replacement ruptured or elongated valve chords with artificial implants to restore the function of the valve. Implanting the standard artificial chordae requires complex and long procedural steps inherent to open heart surgery. 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 temporarily the heart. The ChordArt TMVr-System enables a catheter-based therapy approach that avoids the need for open heart surgery in PMR patients suffering from ruptured or elongated chordae tendineae.
About CoreMedic
CoreMedic GmbH is an innovative 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 ChordArt. The company is backed by a group of experienced and committed private investors with backgrounds in heart medicine and cardiovascular devices and institutional healthcare investor SHS (www.shs-capital.eu).
About ChordArt
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. ChordArt is a catheter designed to deliver implants percutaneously allowing interventions in high-risk as well as asymptomatic patients, which are not eligible for treatment with the current "Gold Standard" of chordal 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 +49173 8821359.
PR Contact:
Josef Bogenschütz
CEO / Managing Director
CoreMedic GmbH
Fritz-Reichle-Ring 2
78315 Radolfzell
GERMANY
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.
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 Bauer
CEO/ General Manager
CoreMedic
Fritz-Reichle-Ring 2
78315 Radolfzell
GERMANY
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.
Description
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.
Evaluation
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.
Conclusions
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.
About CoreMedic:
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
SCIENTIFIC LITERATURE
ChordArt in scientific papers
CHORDART
CHAGALL TRIAL
“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
CHORDART
CHAGALL TRIAL
"Automated Implantation of Artificial Mitral Chords: Preliminary Results From the Feasibility Trial"
Ann Thorac Surg 2020 Feb;109(2):597-602.
REVIEW PAPER
Chorda Repair (TMVr)
"Transcatheter mitral valve repair: review of current techniques"
Indian J Thorac Cardiovasc Surg 2020 Jan;36(Suppl 1):53-63
REVIEW PAPER
Chorda Repair (TMVr)
"Transseptal chordal replacement: early experience"
Ann Cardiothorac Surg 2021 Jan;10(1):50-56
OTHER RESOURCES
Selected links to further related resources
MAYO CLINIC
GERMAN HEART FOUNDATION
Mitralklappeninsuffizienz – die wichtigsten Fakten auf einen Blick
MEDTECH CLUSTER TUTTLINGEN
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