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Wednesday, February 26 2020 - 04:38
New Data Confirms Cardiac Dimensions' Carillon(R) System Shows Favorable Long-Term Survival Rate In Patients With Functional Mitral Regurgitation
KIRKLAND, Washington, Feb. 26, 2020 /PRNewswire-AsiaNet/ --

- Pooled Analysis of Prospective Studies Presented during Late Breaking Trials 
Session at CRT 2020

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 findings of a post hoc analysis of 
pooled prospectively collected data from three studies of the Carillon Mitral 
Contour System(R) with a focus on 5-year survival rate and the determinants of 
long-term survival. The data was presented in a late-breaking trials session at 
the Cardiovascular Research Technologies meeting (CRT 2020) in National Harbor, 

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Dr. Janusz Lipiecki, a cardiologist in the Center for Interventional Cardiology 
of Pôle Santé République in Clermont-Ferrand, France, presented the data on 
behalf of all TITAN, TITAN II and REDUCE FMR clinical study investigators and 
commented, "The recent publication of the REDUCE FMR data demonstrated a 
significant reduction in regurgitant volume and favorable left ventricular 
remodeling(1), confirming the results from prior studies, yet questions 
remained about the long-term impact of the Carillon device." He continued, "As 
an investigator, I am proud to present the results of this analysis 
demonstrating that patients with heart failure and moderate-to-severe FMR who 
underwent transcatheter mitral valve repair with the Carillon device, had a 
favorable 5-year survival rate which was associated with changes in clinical 
and hemodynamic parameters during the first year of follow-up."

A total of 74 patients from the TITAN, TITAN II and REDUCE FMR clinical studies 
who had symptomatic congestive heart failure despite guideline-directed medical 
therapy, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection 
fraction were assessed as part of the analysis. For all patients, 
echocardiographic parameters were available through the 12-month visit and 
vital status was available through 5 years. The association of patient 
characteristics and changes in echocardiographic parameters at 6 and 12 months 
with long-term survival was analyzed using Cox proportional hazards regression. 
Key findings ( 
) from the analysis include:

    -- Over 1 year of follow-up, the New York Heart Association (NYHA) class 
       decreased in 64% of patients, distance on the 6-minute walk test 
       increased, and echocardiographic measures indicated significant
       decreases in MR grade and favorable left ventricular remodeling.(2) 
    -- The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 
       67.9% at 3 years and 56.2% at 4 and 5 years of follow-up.(2)  
    -- Primary determinants of long-term survival were a decrease in NYHA
       class, an increase in 6-minute walk test distance, and a decrease in
       regurgitant volume during the first year of follow-up. (2)
    -- Three-year mortality rate compared to published outcomes of COAPT and 
       guideline directed medical therapy (GDMT), using matched patient 
       populations, was 33.7% for Carillon, 42.8% for MitraClip in COAPT and 
       55.5% for GDMT - Figure 1. (2)

"Mitral regurgitation in the context of heart failure is strongly associated 
with increased morbidity and mortality," commented Steven L. Goldberg, MD, 
Tyler Heart Institute, Community Hospital of the Monterey Peninsula and Chief 
Medical Officer at Cardiac Dimensions. "We continue to see a growing body of 
evidence demonstrating the consistent effectiveness and safety of the Carillon 
System. The long-term data presented today suggests the primary clinical 
benefit of percutaneous mitral valve repair may be enhanced after the ventricle 
has had some time to remodel." He continued, "We have consistently seen 
improvements in left ventricular dimensions, which typically is associated with 
mortality benefits. One would therefore anticipate long-term benefits from a 
decrease in LV volume overload, and these data are supportive."

Gregory D. Casciaro, President and CEO of Cardiac Dimensions, commented, "This 
analysis of three important FMR clinical studies is the first to look at 
five-year follow-up and brings new insights into the long-term role of 
percutaneous treatment." He continued, "We are pleased the results confirm a 
favorable long-term mortality benefit of the Carillon System, supporting the 
significant improvement in MR and favorable remodeling of the left ventricle, 
as shown in REDUCE FMR. This reaffirms the effectiveness and safety of the 
Carillon System and underlines the value of early treatment to slow the 
deterioration of heart failure."

An estimated 26 million people, worldwide, suffer from heart failure(3) 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.(4)

About the Carillon Mitral Contour System(R) 
The Carillon System 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.(5,6)  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.(7,8,9) 

The Carillon System is CE-marked (0344) and has been implanted in over 1100 
patients in the United States, Europe, Australia, Turkey and the Middle East. 
The Carillon System is currently being studied in the CARILLON trial and 
limited to investigational use in the United States.

About Cardiac Dimensions 
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's lead investors include Aperture 
Venture Partners, Arboretum Ventures, 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, visit

Rick Wypych 
(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. Lipiecki J, Kaye DM, Witte KK, et al. Long-Term Survival Following 
       Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials 
       with the Carillon Device. Cardiovascular Revascularization Medicine. 
       Advance online publication ( 
    3. Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing 
       disease and death worldwide. ESC Heart Failure. 2014;1:4-25. 
    4. 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. 
    5. 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. 
    6. Latib, A. "Coronary Sinus Annuloplasty." New York, Montefiore Medical 
    7. 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 
    8. Siminiak T, et. al. Treatment of functional mitral regurgitation by 
       percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 
    9. 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,

Cardiac Dimensions, Carillon and Carillon Mitral Contour System are registered 
U.S. trademarks of Cardiac Dimensions, Pty Ltd

SOURCE  Cardiac Dimensions