CARILLON™ Mitral Annuloplasty Device European Union Study Cardiac Dimensions ® CARILLON ™ Mitral Contour System ™

Disclosures Nothing to Disclose 2

AMADEUS ™ Investigators Hamburg University Cardiovascular Center Prof. Dr. med. Joachim Schofer (PI) - Dr. Thilo Tübler - Ms. Anya Hoffman (Study Coordinator) Universität zu Köln Prof. Dr. med. Uta Hoppe - Dr. Mathias Brandt - Ms. Iris Berg (Study Coordinator) OLVG (Amsterdam) Dr. Jean Paul Herrman Dr. Ton Slagboom (IC) - Dr. Gijsbert de Ruiter (EP) - Dr. Edske ter Bals (Study Coordinator) Cardiac & Rehabilitation Hospital – Kowanówku Prof. Dr. med. Tomasz Siminiak - Dr. Olga Jerzykowska (Echo) - Dr. Piotr Kalmucki (Study Coordinator) Stadtische Kliniken Neuss Prof. Dr. med. Michael Haude - Dr. Hubertus Degen (Study Coordinator) - Dr. Mathias Breise (Echo) AZM (Maastricht) Dr. Luz Maria Rodriguez Dr. J. Vainer (IC) - Dr. David van Kraaij (HF) - Ms. Suzanne Philippines (Study Coordinator) 3

Coronary Sinus approach Results Immediately observable Tension / Plication is controlled by operator Recapture Feature allows for Management of Coronary Arteries Does not preclude other HF therapies such as Bi-V pacing or surgery 4 Percutaneous Annuloplasty for Functional MR

CARILLON ™ Animation 5

The AMADEUS ™ Trial  Study Design: Prospective, single-arm, 30 patient, Six month, multi-center trial  Inclusion Criteria Dilated Ischemic or Non-ischemic Cardiomyopathy (LVEDd > 55mm) NYHA Class II – IV FMR moderate to severe EF < 40% 6 MWT distance between 150m & 450m Stable on heart failure meds  Primary Endpoint: Thirty day rate of Major Adverse Events  Secondary Endpoints: Long-term safety; Hemodynamic and functional changes NYHA Class Exercise (6 minute walk test; Maximum Exercise Time) QOL (KCCQ) Change in MR 6

Baseline Demographics Intent to Treat Population (n=48) AMADEUS ™ Trial Age64 (25-81 yrs) GenderM = 83% (40) F = 17% (8) History of CAD73% NYHA ClassII - 9 III - 37 IV - 2 EF29% (10-39) MR (TEE Procedure Baseline) 2+ = = = 15 LVEDD67 mm (50 – 92 mm) AMADEUS ™ Patients were at High Cardiovascular Risk 7

AMADEUS ™ Enrollment Tree Enrolled Patients N=48 CARILLON ™ “XE” Procedure Initated N=39 Implanted N=29 Procedure Not Initiated N=5 “Original” CARILLON ™ Procedure N=4 Implanted N=1 Not Implanted N=3 Insufficient MR reduction (4) Coronary Compromise (1) Both (5) Dissection / Perforation (3) Screen Failure (2) Slip Not Implanted N=10 8

Major Adverse Event Rate Primary Safety Endpoint at 30 Days EventIntention to Treat (n=48**) Death2.2% (1 / 46) Myocardial Infarction Enzyme bump only. No Sx or EKG change (n=2) Enzyme bump plus EKG change (n=1) 6.5% (3 / 46) CS Perforation During venous access. Non device related 6.5% (3 / 46) Device Embolization0.0% (0 / 46) Surgery or PCI related to device failure0.0% (0 / 46) **Two patients withdrew consent before 25 days F/U Total Major Adverse Events 13% (6/46) (7 events in 6 patients) 9

Managing Coronary Arteries 11 cases of crossed arteries required device “Recapture” In 5 cases, a 2 nd device was successfully placed proximal Arteries crossed in 84% of cases 10

Chronic MR Reduction AMADEUS ™ Implanted Patients (n=30 at Baseline) Quantitative MR Baseline, One, & Six Months cm cm 2 ml % Area P< % Reduction in FMR on 6 months

Sustained Benefit through 6 Mo. MR Reduction / LV Wall Motion Baseline1 Mo3 Mo6 Mo Core Lab MR3+000 NYHAIIII 6 MWT (meters) Max Exercise (sec) QOL (KCCQ) yr old Male Baseline3 Months 6 Months 12

13 NYHA Classification P < n=30n=27n=25 At baseline, 80% of patients were NYHA Class III or IV At 6 Months, 88% of patients were NYHA Class I or II

Six Minute Walk Test P < Meters n=30n=26n=23 14

15 QOL KCCQ Overall Summary P < n=30n=27n=25

QOL Patient portion of Global Assessment Assessment1 month6 months Markedly improved27%36% Moderately improved31%24% Slightly improved19%24% No change11%8% Slightly worse8% Moderately worse0% Markedly worse4%0% n=26 n=25 } 77% } 84% 16

AMADEUS ™ Procedural Times Procedure Times steadily declined over the course of the study Reduced Procedure time benefits sick HF Population Minutes 17

At BaselineAfter Deployment CARILLON™: Poznan case

AMADEUS ™ Study Conclusions  AMADEUS ™ study achieved its safety endpoint with an acceptable MAE profile. 13% MAE 30 days was primarily non-device related.  At-risk coronary arteries were successfully managed in AMADEUS ™ with the CARILLON ™ “recapture” feature.  MR was reduced by 27% out to 6 months.  Statistically significant improvements in functional parameters out to 6 months (e.g., exercise, NYHA, QOL).  Short, simple procedure is important for this unstable HF patient population. 19