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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.

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

"Automated Implantation of Artificial Mitral Chords: Preliminary Results From the Feasibility Trial"
Ann Thorac Surg 2020 Feb;109(2):597-602.

REVIEW PAPER

Chorda Replair (TMVr)

"Transseptal chordal replacement: early experience"
Ann Cardiothorac Surg 2021 Jan;10(1):50-56

REVIEW PAPER

Chorda Replair (TMVr)

"Transcatheter mitral valve repair: review of current techniques"
Indian J Thorac Cardiovasc Surg 2020 Jan;36(Suppl 1):53-63

 

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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