Why Refer Your Patients to the EMPOWER Trial?
The EMPOWER Trial evaluates the Carillon Mitral Contour System® vs. medical management as a first-line device option to treat many functional MR patients suffering from heart failure.
Today, earlier-stage FMR patients have no approved treatment when medication no longer manages their heart failure symptoms. These early stage FMR patients with MR grade I-II, as well as patients with MR grade III-IV, could benefit from an FDA-approved device therapy that is minimally-invasive and simple to implant that addresses FMR before damage becomes permanent.
- Studying patients with MR grades I-IV caused by enlarged left ventricle
- Inclusive of patients with earlier-stage FMR
- First U.S. randomized, blinded, sham-controlled mitral repair trial
- Allows for alternative therapy within trial to avoid dropouts
Study Design & Primary Endpoints
Who is Eligible for the EMPOWER Trial?
Find a Study Site
About the Therapy – Carillon Mitral Contour System
View the Carillon procedure
- Minimally invasive
- Short procedure, often about one hour
- Has been evaluated in several clinical studies, including a blinded randomized, controlled study, which demonstrated that the procedure had an excellent safety profile, and that patients implanted with the Carillon device and using medical therapy were more likely to have reduced mitral regurgitation and experience a reduction in heart size as compared to patients who were treated with medical therapy alone1
- Has received CE Mark in Europe and is included in the European Society of Cardiology (ESC) guidelines covering the diagnosis and treatment of acute and chronic heart failure for the treatment of secondary mitral regurgitation
- Thousands of patients treated worldwide
I’d like more information on the EMPOWER Trial for my patients
Share these trial resources with your interested patients
- 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.