REDUCE FMR Study Shows Cardiac Dimensions' Carillon® System Significantly Improves Mitral Regurgitation And Slows Worsening Of Heart Failure

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

KIRKLAND,Washington,Sept. 12,2019 -- 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®. 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

"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. Klaus Witte,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®

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.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 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.

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