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Thursday, September 12 2019 - 21:04
AsiaNet
REDUCE FMR Study Shows Cardiac Dimensions' Carillon(R) System Significantly Improves Mitral Regurgitation And Slows Worsening Of Heart Failure
KIRKLAND, Washington, Sept. 12, 2019 /PRNewswire-AsiaNet/ --

--Published in peer-reviewed Journal of the American College of Cardiology: 
Heart Failure 

Cardiac Dimensions, a leader in the development of innovative, minimally 
invasive treatments for functional mitral regurgitation (FMR) in patients with 
heart failure (HF), today announced the publication of the REDUCE FMR clinical 
study of its Carillon Mitral Contour System(R). The Carillon(R) System is a 
right heart transcatheter mitral valve repair (TMVr) device designed to treat 
the primary cause of FMR in patients with MR grades 2+, 3+ and 4+. 

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"We know that mitral regurgitation in the context of heart failure is strongly 
associated with increased morbidity and mortality," commented Prof. Horst 
Sievert, M.D., Director and Founder of the Cardiovascular Center Frankfurt. 
"Carillon provides an option to treat a large portion of FMR patients with a 
minimally-invasive treatment that doesn't compromise the valve leaflets. 
Patients across a wide spectrum of MR grade and NYHA class benefited from 
Carillon treatment, experiencing significant improvements in MR and favorable 
remodeling of the left ventricle. Heart failure is a progressive disease and we 
need options that allow for progressive treatment." 

The REDUCE FMR study was a blinded, multicenter, randomized, sham-controlled 
clinical trial that enrolled 120 patients at 31 sites in the EU, Australia and 
New Zealand. Patients on optimal heart failure medical therapy with FMR were 
randomized 3:1 to receive treatment with the Carillon or a non-implant sham 
procedure. The primary endpoint was change in mitral regurgitant volume (RV) at 
1-year, as assessed by Cleveland Clinic's blinded Vascular Core Lab. Secondary 
endpoints included change in left ventricular end diastolic volume (LVEDV) and 
left ventricular end systolic volume (LVESV) as compared to baseline, major 
adverse events (MAE) and heart failure hospitalizations (HFH) at 1-year. 

The study met its primary endpoint, while enrolling a less severe patient 
population, and was published in the Journal of the American College of 
Cardiology: Heart Failure. 
http://heartfailure.onlinejacc.org/content/early/2019/09/06/j.jchf.2019.06.011 
Klaus Witte, M.D., cardiologist at Leeds Teaching Hospital NHS Trusts in the UK 
and a top enroller in the study, commented, "The Carillon System is the first 
mitral valve repair device to demonstrate a significant reduction in 
regurgitant volume and favorable LV remodeling, indicating a size reduction of 
the left ventricle. The convincing one-year data shows the Carillon System can 
slow the progression of heart failure and will provide hope to many of my 
patients." 

Key results from the REDUCE FMR study include1:

    --  Treatment with the Carillon device resulted in a statistically 
        significant reduction of mitral regurgitant volume vs. the control
        group (decrease of 7.1 mL/beat vs. an increase of 3.3 mL/beat; p=0.049) 
    --  Treatment with the Carillon device induced a significant reduction of 
        left ventricular volumes vs. the control group, (LVEDV: decrease of 
        10.4 mL vs. an increase of 6.5 mL; p=0.03 and LVESV: decrease of 6.2 mL 
        vs. an increase of 6.1 mL; p=0.04) 
    --  Significant improvements in regurgitant volume and LVEDV were observed 
        across all MR grades with the absolute improvement in both measures the 
        greatest in patients with MR grades 3+ and 4+ after 12 months 
        (reduction of mitral regurgitant volume: 12.8 ± 21.6 (n=15), change in 
        LVEDV: -26.9 ± 16.3 (n=13) and change in LVESV: -17.5 ± 18.9 (n=13)) 
    --  Patients treated with the Carillon device had a significant improvement 
        in 6-minute walk distance at 12 months compared with baseline (p=0.002) 
        whereas patients in the control group did not (p=0.29) 
    --  Patients in the Carillon treatment group had a significant improvement 
        in NYHA class at 12 months compared with baseline (p=0.002) whereas  
        patients allocated to the control group did not (p=0.75) 
    --  The Carillon device showed a positive safety profile with a similar 
        incidence of major adverse events between groups through the follow-up 
        period 
    --  Treatment with the Carillon device enabled patients to experience 48% 
        fewer repeat (>1) heart failure hospitalizations during follow-up (11% 
        v 21%, p=0.23).

"We are pleased with the outcome of the REDUCE FMR study and the significant 
benefit the Carillon System brings to patients," said Gregory D. Casciaro, 
President and CEO of Cardiac Dimensions. "This study adds to the growing body 
of evidence demonstrating the effectiveness and safety of the Carillon System 
for FMR patients and underlines the value of treating earlier in the disease to 
slow the deterioration of heart failure," he continues. "We are leveraging 
these positive clinical results, along with the German DRG reimbursement and 
expansion to other EU markets, to quicken the commercial adoption of the 
Carillon System." 

An estimated 26 million people, worldwide, suffer from heart failure2 and of 
those, approximately 70 percent have FMR. Heart failure is a significant 
clinical and economic burden with direct and indirect costs expected to grow to 
$70 billion by 2030.3

About the Carillon Mitral Contour System(R)
The Carillon System(R) offers a simple right heart approach to transcatheter 
mitral valve repair (TMVr) designed to reshape the anatomy and function of the 
mitral apparatus from the coronary sinus. Distal and proximal anchors, 
connected by a shaping ribbon, utilize the heart's venous anatomy to cinch the 
mitral apparatus, without compromising the valve or future treatment 
options.4,5  The Carillon System is designed to treat the primary cause of 
functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+ 
and is the first and only device to demonstrate a reduction in regurgitant 
volume and favorable left ventricular remodeling in a randomized 
sham-controlled clinical trial of percutaneous valve therapy. 6,7,8 

The Carillon System is CE-marked (0344) and has been implanted in over 1000 
patients in Europe, Australia, Turkey and the Middle East. The Carillon System 
is currently being studied in a pivotal trial in the United States. The 
Carillon Mitral Contour System is limited to investigational use in the United 
States.

About Cardiac Dimensions, Inc.
Cardiac Dimensions is a leader in the development of innovative, minimally 
invasive treatments to address heart failure and related cardiovascular 
conditions. Privately held, the company is funded by Aperture Venture Partners, 
Arboretum Ventures, Difference Capital, HostPlus, Life Sciences Partners, 
Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in 
Kirkland, Washington and has operations in the United States, Australia and 
Germany. For more information, please visit https://cardiacdimensions.com.

MEDIA CONTACT:
Rick Wypych
rwypych@cardiacdimensions.com
(425) 605-5910

1. 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 I, DOI: 10.1016/j,jchf.2019.06.011
2. Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease 
and death worldwide. ESC Heart Failure. 2014;1:4--25. 
3. Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the Impact of Heart 
Failure in the United States. Circ Heart Fail. 2013;6(3):606-19.
4. Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device 
leaves free access to cardiac veins for resynchronization therapy. Catheter 
Cardiovasc Interv. 2009;74(3):506-11.
5. Latib, A. "Coronary Sinus Annuloplasty." New York, Montefiore Medical Center.
6. 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
7. Siminiak T, et. al. Treatment of functional mitral regurgitation by 
percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 
2012;14:931-38.
8. Sievert, H. 2018. REDUCE-FMR: A Sham Controlled Randomized Trial of 
Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with 
Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA.
 
SOURCE: Cardiac Dimensions