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Information for Healthcare Professionals

Carillon Therapy

Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure (HF) with a completely different treatment approach to help patients live longer, higher quality lives.

Our Carillon Mitral Contour System® is a groundbreaking, non-surgical device developed with the goal to safely and effectively treat patients with mitral valve insufficiency.

The Carillon Therapy is the only indirect, no-touch, mitral valve repair option designed to produce an annuloplasty effect (i.e. cinching of the valve annulus). International studies have shown that patients treated with the Carillon Therapy often experience positive left ventricular remodeling and have favorable long-term (3-year) survival.1, 2, 3 The Carillon Device is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the main cause of functional mitral regurgitation (FMR)—not just the symptoms. The Carillon Therapy can also be used alongside other heart failure treatments should they be needed.4, 5

The distal and proximal anchors of the Carillon Device are connected by a shaping ribbon that utilizes the heart’s venous anatomy to cinch the mitral apparatus.

Cardiac Dimensions Carillon System
BEFORE Carillon implant

BEFORE Carillon Implant

AFTER Carillon implant

AFTER Carillon Implant

Cardiac Dimensions Carillon System

The Carillon Implant is deployed using familiar catheter techniques. In addition, real time assessments of implant deployment safety and MR reduction efficacy can be assessed prior to release of the implant. This allows for complete recapture of the implant – if necessary.

Additional benefits of this simple right-heart approach include:

  • No transseptal puncture
  • Short 1-hour average implant time1,2,3
  • Ability to treat less sick (MR grade 2+) patients
  • Preserves future treatment options such as CRT
  • Conscious sedation
  • 10 Fr venous access
  • No long-term DAPT
  • Short user learning curve
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Results

To date, four separate trials have evaluated the safety and performance of the Carillon Therapy—AMADEUS, TITAN, TITAN II, and REDUCE FMR. The latest, the REDUCE FMR Trial, was a landmark fully randomized, blinded, sham-controlled trial of patients. A fifth U.S. pivotal trial, the EMPOWER Trial, is currently enrolling in the United States as well as select other geographies worldwide.

Results show that FMR patients treated with the Carillon Therapy experienced a mean acute regurgitant volume (RV) reduction of 8 ml and had favorable long-term (3-year) survival.6,7 In addition, the majority of the patients experience positive results in mechanistic and clinical end points through 12 months.

Results from the latest completed trial, REDUCE FMR, are summarized below.

REDUCE FMR Clinical Trial

The Carillon Therapy is the only TMVr therapy to demonstrate favorable left ventricular remodeling at one year and a significant reduction in RV in a double-blinded, randomized, sham-controlled trial (REDUCE FMR). The trial met its primary endpoints and results were consistent with the prior TITAN and TITAN II single-arm, multi-center studies.1,2,3

Key inclusion criteria

  • MR Grade 2+ to 4+
  • NYHA Class II–IV
  • LVEF ≤50%

As a result of site assessed MR grade for the inclusion of patients (and subsequently reviewed by an independent core lab), the following breakout of patients by MR grade were enrolled in the trial:

Characteristics of Randomized Patients at Baseline According to ITT Analysis

 Total (N = 120)Control (n = 33)Treatment (n = 87)
Men87 (72.5)24 (72.7)63 (72.4)
Mean age, yrs69.8 ± 9.569.1 ± 8.970.1 ± 9.7
Cause
Ischemic heart disease80 (66.7)21 (63.6)59 (67.8)
Nonischemic cardiomyopathy40 (33.3)12 (36.4)28 (32.2)
Diabetes mellitus36 (30.0)12 (36.4)24 (27.6)
BMI, kg/m227.1 ± 5.628.1 ± 6.226.7 ± 5.3
NYHA functional class
II55 (45.8)16 (48.5)39 (44.8)
III63 (52.5)17 (51.5)46 (52.9)
IV2 (1.7)0 (0.0)2 (2.3)
Beta blockers109 (90.8)32 (97.0)77 (88.5)
ACE inhibitor/ARB/ARNi108 (90.0)29 (87.9)79 (90.8)
Diuretic agent118 (98.3)33 (100)85 (97.7)
MRA diuretic agent73 (60.8)19 (57.6)54 (62.1)
NT-pro-BNP2,430 (1,092-4,440)2,410 (1,151-4,820)2,505 (1,095-4,386)
Device (ICD or PPM)55 (45.8)12 (36.4)43 (49.4)
Atrial fibrillation71 (59.2)20 (60.6)51 (58.6)
Baseline heart rate, beats/min70 ± 1270 ± 1170 ± 13
Systolic BP, mmÿHg119 ± 17119 ± 19118 ± 16
Diastolic BP, mmÿHg70 ± 1167 ± 1371 ± 11
6-min walk test302.6 ± 90.6292.6 ± 91.5306.4 ± 90.5
LVEF, %34 ± 937 ± 934 ± 9
LVEDD, cm6.4 ± 0.96.4 ± 0.96.4 ± 0.9
LVESD, cm5.5 ± 1.05.3 ± 1.15.5 ± 1.0
LVEDV, ml187.4 ± 67.9188.6 ± 75.7187.0 ± 65.6
LVESV, ml126.1 ± 56.8122.0 ± 59.8127.4 ± 56.1
Mitral regurgitant volume, ml/beat39.9 ± 23.838.1 ± 24.040.4 ± 23.9
Mitral regurgitant grade
1+35 (29.7)10 (32.3)25 (28.7)
2+42 (35.6)8 (25.8)34 (39.1)
3+34 (28.8)11 (35.5)23 (26.4)
4+7 (5.9)2 (6.5)5 (5.7)
Mean creatinine, mmol/l114.1 ± 31.9118.8 ± 34.1112.3 ± 31.1

Values are n (%), mean ± SD, or median (interquartile range). There were no significant differences between the groups on appropriate post hoc testing. Conversion factors: creatinine mmol/l × 0.011 = mg/dl.

ACE = angiotensin-converting enzyme inhibitor; ARB = aldosterone receptor blocker; ARNi = angiotensin receptor-neprilysin inhibitor; BMI = body mass index; BP = blood pressure; ICD = implantable cardioverter-defibrillator; ITT = intention to treat; LVEDD = left ventricular end-diastolic diameter; LVEDV = left ventricular end-diastolic volume; LVEF = left ventricular ejection fraction; LVESD = left ventricular end-systolic diameter; LVESV = left ventricular end-systolic volume; MRA = mineralocorticoid receptor antagonists; NT-pro-BNP = N-terminal pro–B-type natriuretic peptide; NYHA = New York Heart Association; PPM = permanent pacemaker.

Despite treating patients across all MR grades, including those with less severe regurgitation (i.e., MR 1+), the study still showed significance in its end points.

Primary endpoint

Change in regurgitant volume at one year, as assessed by a blinded, independent echo core lab.

120 patients in EU and Australia randomized 3:1

  • 87 randomized to treatment (Carillon Therapy)
  • 33 randomized to sham control (guideline-directed medical therapy)

Significant Reduction in Regurgitant Volume

Mean Change in RV (ml) at 1 Year (ITT)

Significant Favorable Left Ventricular Remodeling

Mean Change in LVEDV at 1 Year (ITT)
Mean Change in LVESV at 1 Year (ITT)

Recurrent Heart Failure Hospitalizations and Total Heart Failure Admissions

Recurrent HF Hospitalizations (AT)
Rate of total HF Admissions (AT) (Per Patient Year)

AT = As-Treated Population (n=106)
ITT = Intention-to-Treat Population (n=120)

Positive Safety Profile

  • 98.9% freedom from device-related major adverse events through 1 year*
  • Low major adverse event rate at 30 days and 12 months in treatment-only group

*Events adjudicated by independent committee as related to device.

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    Cardiac Dimensions logo - horizontal

    © 2021 Cardiac Dimensions. All rights reserved.

    NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.

    CAUTION: Investigational Device. Limited by United States law to investigational use.

    Cardiac Dimensions logo - horizontal

    © 2022 Cardiac Dimensions. All rights reserved.

    NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.

    CAUTION: Investigational Device. Limited by United States law to investigational use.