KIRKLAND, Washington., September 22, 2021 / PRNewswire / – Cardiac Dimensions, a Leader in the Development of Innovative, Minimally Invasive Treatment Modalities to Treat Heart Failure and Associated Cardiovascular Conditions, Today Announced Reference to its Carillon Mitral Contour System in the Guidelines 2021 of the European Society of Cardiology (ESC) for the diagnosis and treatment of acute and chronic heart failure. In addition, the Carillon mitral contour system can now be taken into account as part of the new 2021 class IIb recommendations for the management of heart valve disease on the indications for mitral valve intervention in severe secondary mitral insufficiency. chronic. Both guidelines were recently published in the European Journal of the Heart.
The latest guidelines, referring to the Carillon Mitral Contour System, indicate that other percutaneous mitral valve repair systems, such as indirect annuloplasty, are available for the treatment of secondary mitral regurgitation (SMR). The guidelines also state that the approach has a shorter learning curve, fewer technical requirements than percutaneous edge-to-edge mitral valve repair, and does not exclude different procedures once performed. The guidelines section continues with reference to the Cardiac Dimensions REDUCE FMR trial which was blinded, sham-controlled, randomized, and which met its primary endpoint of mitral regurgitation volume reduction with remodeling of the heart. left ventricle reversed at 12 months.
The guidelines then refer to other studies from Cardiac Dimensions which confirm the favorable results of the Carillon Mitral Contour System on left atrium volumes and left ventricular remodeling with trends in improving clinical measurements and a reduction in hospitalizations for heart failure. Given the newly introduced option of ‘other percutaneous therapies’ in the valve disease guidelines and being the only non-TEER device mentioned in the heart failure guidelines, the Carillon Mitral Contour System can now be considered the only other non-TEER Class IIb option in the treatment of SMR.
âI am very happy to see the Carillon Mitral Contour System mentioned in the 2021 ESC Heart Failure Guidelines,â commented Prof. Dr. Horst Sievert, director of the Cardiovascular Center of Frankfurt and the director of internal medicine, cardiology and vascular medicine at Sankt-Katharinen-Hospital. âAnd even more exciting is having the ability to have other valve catheter therapies within the ESC 2021 valve guidelines with the Carillon device the only other device mentioned for use. With so little of it. options available to my SMR patients, it’s great to see additional options added to the guidelines. “
The guidelines are considered an important tool for the assessment of heart failure patients with valve disease in the Europe. They provide relevant information on each disease addressed as well as a very didactic approach and algorithms for patient management. Until recently, the RMS treatment paradigm focused on the medical management of symptoms, but promising evidence now points to the role that transcatheter device treatment options may play today and in the future.
Percutaneous catheter techniques for improving RMS have broadened the spectrum of patients who may benefit from mitral valve intervention. The most recent recommendations provide an updated practical approach to the management of heart failure and SMR patients based on a multidisciplinary cardiac team approach and have begun to expand the tools authorized to treat patients.
“Being the only device, other than TEER, mentioned in the ESC 2021 guidelines for the treatment of secondary mitral regurgitation is testament to our excellent clinical data and the overwhelming need for additional treatment options in space,” said Rick wypych, President and CEO of Cardiac Dimensions. âWe have already seen, with the unveiling of the guidelines, more hospitals becoming aware of the Carillon Mitral Contour system as an important option in the treatment of their patients. “
It is estimated that 26 million people worldwide suffer from heart failure1 and of these, about 49 percent have SMR.2 Heart failure is a significant clinical and economic burden, the direct and indirect costs of which are expected to reach $ 70 billion by 2030.3
For a copy of the â2021 European Society of Cardiology Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failureâ, please visit: https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ ehab368 / 6358045
About the Carillon Mitral Contour System
Cardiac Dimensions is reinventing the solutions available to patients with heart failure by providing therapy that enables patients to live longer and better lives. Our product, the Carillon Mitral Contour System, is a revolutionary minimally invasive non-surgical device developed to treat patients with mitral valve insufficiency safely and effectively. Carillon therapy is the only indirect, non-contact mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term patient survival. Carillon therapy can also be used with other treatments for heart failure if needed.
To date, more than 1,500 patients have been treated with the Carillon system around the world. Clinical data from over 250 patients in four previously completed studies of the Carillon System provided the basis for demonstrating the safety and performance of the Carillon device as well as for the associated CE marking, which enables commercial sales in Europe. In addition, the pivotal American study, The EMPOWER Trial, is currently recruiting patients in the United States as well as in selected centers around the world.
About cardiac dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to treat heart failure and associated cardiovascular conditions. If left untreated, secondary mitral regurgitation contributes to heart failure, a chronic, progressive disease that weakens the heart and makes daily activities difficult. The Carillon System solves the underlying mechanical problem of secondary mitral regurgitation with a catheter-based alternative to drugs and invasive surgery.
Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, germany.
The Carillon Mitral Contour System is approved for sale in Europe by its CE mark and is an experimental device in the United States. For more information, please visit dimensionscardiaques.com.
1Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death around the world. ESC heart failure. 2014; 1: 4-25.
2Koelling T, et al. American Heart Journal. Volume 144, Number 3, September 2002, pages 524-529. Prognostic significance of mitral regurgitation and tricuspid regurgitation in patients with left ventricular systolic dysfunction.
3Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, et al. Predicting the future of cardiovascular disease by United States: an American Heart Association policy statement. Circulation. 2011; 123 (8): 933â44.
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