Physicians

Carillon System

The Carillon Mitral Contour System® is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the main cause of functional mitral regurgitation (FMR) in patients with MR grades 2+ to 4+.

MR in the context of heart failure is strongly associated with adverse patient outcomes,1 including one-year mortality rates up to 27% if left untreated.2

Designed to reshape the anatomy and improve function of the mitral apparatus from the coronary sinus, the Carillon System reduces regurgitant volume (RV) and induces favorable left ventricular remodeling without compromising the valve3, 4, 5 or future treatment options.6, 7

Using familiar catheter techniques, the device can be recaptured and retrieved prior to release.

Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus.

Simple Right-Heart Procedure

Easy to use with a short learning curve and no transseptal puncture

Results

To date, four separate trials have evaluated the safety and performance of the Carillon System – AMADEUS, TITAN, TITAN II, and REDUCE FMR. Results have shown that FMR patients treated with the Carillon System experience a mean acute RV reduction of 8 ml and have favorable long-term (3-year) survival.8,9

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

REDUCE FMR Clinical Trial

The Carillon System is the first TMVr therapy to demonstrate favorable left ventricular remodeling at one year and significant reduction in regurgitant volume in a double-blinded, randomized, sham-controlled trial (REDUCE FMR). The trial met its primary endpoint and results were consistent with the prior TITAN and TITAN II single-arm, multi-center studies.3, 4, 5

Key inclusion criteria

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

Primary endpoint

Change in regurgitant volume at 1 year, as assessed by blinded echo core lab

120 patients in EU and Australia randomized 3:1

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

Significant Reduction in MR

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

Significant Favorable LV Remodeling

Mean Change in LVEDV at 1 Year (ITT)

Mean Change in LVESV at 1 Year (ITT)

Recurrent HF Hospitalizations and Total HF 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 MAE through 1 year*
  • Low MAE rate at 30 days and 12 months in treatment-only group

*Events adjudicated by independent committee as related to device.

  1. Baskett RJF, Exner DV, Hirsch GM, Ghali WA. Mitral insufficiency and morbidity and mortality in left ventricular dysfunction. Can J Cardiol. 2007;23(10):797-800.
  2. Trichon BH, Felker GM, Shaw LK, Cabell CH, O’Connor CM. Relation of frequency and severity of mitral regurgitation to survival among patients with left ventricular systolic dysfunction and heart failure. Am J Cardiol. 2003 Mar 1;91(5):538-43. [MR 3+ and 4+]
  3. 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.
  4. 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: e000411.
  5. 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. DOI: 10.1016/j.jchf.2019.06.011.
  6. 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.
  7. Latib, A. “Coronary Sinus Annuloplasty.” New York, Montefiore Medical Center.
  8. Stöbe, Stephan, et al. “Echocardiographic Analysis of Acute Effects of Percutaneous Mitral Annuloplasty on Severity of Secondary Mitral Regurgitation.” ESC Heart Failure, 2 May 2020, doi:10.1002/ehf2.12719.
  9. Lipiecki, D.M. Kaye, K.K. Witte, et al., Long-term survival following transcatheter mitral valve repair: Pooled analysis ofprospective trial…, Cardiovascular Revascularization Medicine.
  10. Data on file. Percent change calculated by averaging individual patient percent changes.