Country for PR: United States
Contributor: PR Newswire New York
Thursday, June 13 2019 - 23:10
New Data Shows The Carillon Mitral Contour System(R) Is Associated With Improvement In Regurgitant Volume In Patients With Increased Mitral Valve Tenting
CHICAGO, June 13, 2019 /PRNewswire-AsiaNet/ --

-- Data Presentation & Lunch Symposium at TVT2019 Structural Heart Summit

Cardiac Dimensions ( 
), a leader in the development of minimally invasive treatments for functional 
mitral regurgitation (FMR) in patients with heart failure, presented data at 
the TVT2019 Structural Heart Summit showing increased mitral valve tenting is 
associated with an improvement in regurgitant volume with the 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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Previous studies have shown that increased tenting dimensions predict residual 
or recurrent mitral regurgitation after surgical restrictive annuloplasty[1]. 
To assess the consistency of this predictive assessment, a retrospective 
analysis of 125 Carillon patients enrolled in the TITAN, TITAN II and REDUCE 
FMR clinical studies assessed the relationship between baseline tenting area 
and tenting height (coaptation distance) on percent regurgitant volume (RV) 
change and percent left ventricular end diastolic volume (LVEDV) change. 

Steven L. Goldberg, MD, Tyler Heart Institute, Community Hospital of the 
Monterey Peninsula, presented the data on behalf of Cardiac Dimensions and 
commented, "This data confirms that unlike surgical annuloplasty, increased 
tenting dimensions are NOT associated with worse outcomes when a Carillon 
indirect annuloplasty is performed." He continued, "The data shows coaptation 
height and tenting area are predictors of positive outcomes with the Carillon 
system and the best responders have a higher baseline tenting area, suggesting 
perhaps the Carillon system not only decreases the mitral annulus but may also 
improve mitral annular function, while inducing favorable LV remodeling."

The Carillon System is being highlighted in a lunch symposium, sponsored by 
Cardiac Dimensions, on Friday, June 14th at TVT2019. Interested attendees can 
register at

Contemporary Treatment of Functional MR in Patients with Heart Failure
Carillon Mitral Contour System Background: REDUCE FMR 
     Prof. Horst Sievert, MD, Cardiovascular Center, Frankfurt, Germany
CARILLON Trial Update 
     Samir R. Kapadia, MD, Cleveland Clinic, Cleveland, OH
Carillon Mitral Contour System Procedure
     Steven L. Goldberg, MD, Tyler Heart Institute, Monterey, CA
Combination Therapy in FMR: Case Experience 
     Felix Kreidel, MD, University Hospital Mainz, Germany 
Panel discussion 
     Martin B. Leon, MD, Columbia University, New York, NY

"We are pleased with the positive momentum we've been experiencing due to the 
growing body of evidence demonstrating the effectiveness and safety of the 
Carillon System," commented Gregory D. Casciaro, President and CEO of Cardiac 
Dimensions. "This study shows the positive impact Carillon can have on patients 
with severe coaptation issues and demonstrates an opportunity to treat a 
patient population previously nonresponsive to other annuloplasty therapies."

An estimated 26 million people, worldwide, suffer from heart failure[2] 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
The Carillon System offers a simple right-heart approach to transcatheter 
mitral valve repair (TMVr) designed to reshape the anatomy and improve 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 reverse 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 980 
patients in Europe, Australia, Turkey and the Middle East. The Carillon System 
is approved for investigational use in the United States.

About Cardiac Dimensions, Inc.
Cardiac Dimensions is a leader in the development of 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, visit

Rick Wypych
+1 (425) 605-5910

1. Magne, Pibarot, Dagenais, et al. Preoperative posterior leaflet angle 
accurately predicts outcome after restrictive mitral valve annuloplasty for 
ischemic mitral regurgitation. Circulation. 2007;115:782-791 
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 
6. Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous 
annuloplasty as treatment for functional mitral regurgitation: 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. 
8. Sievert, H. 2018. REDUCE-FMR: Sham Controlled Randomized Trial of 
Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with 
Functional Mitral Regurgitation. Presented at TCT 2018, San Diego.

SOURCE: Cardiac Dimensions