For Patients with Heart Failure
Heart Failure and Functional Mitral Regurgitation
If you have heart failure, you know the devastating symptoms and how they affect your quality of life. The exhaustion. The loss of energy. The loss of breath. Simple daily activities like preparing meals, visiting with friends, or even moving from room to room can require significant effort. An estimated 26 million people suffer from heart failure worldwide, and the number is growing rapidly.1
Heart failure is a condition in which the heart is unable to pump enough blood to the body. The heart tries to compensate by growing larger. This increase in size causes the mitral valve to stretch, which in turn leads to the mitral valve leaking and mitral regurgitation. Unfortunately, this further compromises the function of the heart, worsening the heart failure over time.
Functional mitral regurgitation (FMR) is due to the mitral valve not closing properly, resulting in blood flowing or leaking backwards in the wrong direction. This further decreases the amount of oxygenated blood that is pumped out to the body, increases the symptoms associated with heart failure and often decreases the quality of life.
The Carillon Mitral Contour System® is a minimally invasive treatment option, uniquely designed to treat FMR. The Carillon System is placed using a non-surgical, catheter-based technique in a vein on the outside of the heart which is next to the mitral valve. This break-through innovation is engineered to reshape the mitral valve, reduce valve leakage, and thereby reduce mitral regurgitation.
Results from multiple, non-US, international clinical studies demonstrate that the Carillon Therapy is effective in reducing the amount of mitral regurgitation and remodeling the heart. Recipients of the Carillon Device typically experience improvement in heart failure symptoms and overall quality of life.2, 3, 4, 5
Gundula Regains Her Life
- Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25.
- Schofer J, Siminiak T Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye D, Duffy SJ, Tübler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous Mitral Annuloplasty for Functional Mitral Regurgitation Results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation 2009; 120: 326-333.
- Siminiak, T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug; 14(8): 931-8.
- Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. BMJ Open Heart. 2016; 3: e000411.
- Witte K, et al. A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation: The REDUCE FMR Trial. J Am Coll Cardiol HF. DOI: 10.1016/j.jchf.2019.06.011.
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NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.
CAUTION: Investigational Device. Limited by United States law to investigational use.