New Data Shows The Carillon Mitral Contour System® Is Associated With Improvement In Regurgitant Volume In Patients With Increased Mitral Valve Tenting

Data Presentation & Lunch Symposium at TVT2019 Structural Heart Summit

CHICAGO, June 13, 2019 /PRNewswire/ -- 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^®. The Carillon^® 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+.

Carillon Mitral Contour System

Previous studies have shown that increased tenting dimensions predict residual or recurrent mitral regurgitation after surgical restrictive annuloplasty¹. 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 14^th at TVT2019. Interested attendees can register at https://www.crf.org/tvt/the-conference/satellite-programs.

"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 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
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 cardiacdimensions.com.

MEDIA CONTACT:
Rick Wypych
rwypych@cardiacdimensions.com
(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 Center.
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. 2012;14:931-38.
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.

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