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Technology Update and Status of Current Clinical Trials

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Presentation on theme: "Technology Update and Status of Current Clinical Trials"— Presentation transcript:

1 Technology Update and Status of Current Clinical Trials
The MitraClip® Therapy Ferolyn Powell General Manager Abbott Vascular Structural Heart Investigational Device only in the US; Not available for sale in the US

2 The MitraClip® Therapy: A New Treatment Option
Investigational Device only in the US; Not available for sale in the US

3 MitraClip® Therapy Deliver Consistent Results Globally
Physicians at ~ 80 hospitals in Europe and nearly 40 clinical trial sites in the U.S. have treated over 2,600 patients with the MitraClip® system Iceland Sweden Finland Norway Russia Estonia Latvia Denmark Lithuania Ireland Russia Kazakhstan United Kingdom Belarus Netherlands Germany Poland Belgium Luxembourg Ukraine Czech Rep. Slovakia Liechtenstein Moldova Austria France Switzerland Hungary Slovenia Romania Italy Croatia Georgia Bosnia & Herzegovina Azerbaijan Armenia Marino San Serbia Portugal Andorra Montenegro Bulgaria Spain Macedonia Iran Albania Turkey Greece Syria Cyprus Iraq Malta Lebanon Morocco Algeria Tunisia Israel Jordan 500 Miles 500 KM Saudi Arabia Libya Egypt Investigational Device only in the US; Not available for sale in the US

4 MitraClip® Therapy Multi-disciplinary Team Approach
Cardiac Surgeon Participate in patient selection Consult during procedure May Implant the device Interventional Cardiologist Echocardiologist Procedural image guidance (TEE) Heart Failure Specialist/Clinical Cardiologist/Referring Physician Participate in patient selection Manage aftercare Anesthesiologist General Anesthesia Cath Lab Staff Patient and procedure preparation Nursing Staff Aftercare Investigational Device only in the US; Not available for sale in the US

5 MitraClip® Therapy Start Up Supported by a Robust Training Program
Patient Selection Etiology, Anatomy, Co-morbidities Pre-procedure Preparation Procedural Success Optimal patient outcome MitraClip® system functions Procedural imaging Procedural Efficiency Systematic approach Standardized procedure and images Clear and consistent terminology Post-procedure Considerations Investigational Device only in the US; Not available for sale in the US

6 MitraClip® Therapy Worldwide Experience
>3400 Devices Implanted * High-surgical Risk estimated based on : Logistic EuroSCORE ≥ 20; or STS score ≥ 12%; or Surgeon estimate of mortality ≥ 12% Estimate Estimates of worldwide clinical experience as of January 29th, 2011 Investigational Device only in the US; Not available for sale in the US

7 MitraClip® Therapy Worldwide Prospective Clinical Studies
Core-lab Echo Data: >1,000 total ~ 200 each with 1-year follow-up ~ 100 each with 2-year follow-up * High-surgical Risk estimated based on : Logistic EuroSCORE ≥ 20; or STS score ≥ 12%; or Surgeon estimate of mortality ≥ 12% Estimates of worldwide clinical experience as of January 29th, 2011 Investigational Device only in the US; Not available for sale in the US

8 Safety: 30 Day MAE Intention to Treat
# (%) Patients experiencing event Device Group Control Group (n=95) All (n=184) No Cross-Over ≤ 30 days (n=170) Death 2 (1.1%) 2 (2.1%) Major Stroke 1 RNT Re-operation of Mitral Valve 1 (1.1%) Urgent / Emergent CV Surgery 4 (2.2%) 4 4 (4.3%) Myocardial Infarction Renal Failure 1 (0.6%) 1 Deep Wound Infection Ventilation >48 hrs New Onset Permanent Atrial Fib Septicemia GI Complication Requiring Surgery Transfusions ≥ 2 units of blood 24 (13.3%) 12 42 (44.7%) TOTAL % of Patients with MAE 15.0% 47.9% Difference (Device – Control) = -32.9 p<0.0001; (95% CI: -45.0%, -20.7%) Source: Adapted from Feldman, T. EVEREST II RCT, TCT PML03371 Rev. A. Investigational Device only in the US; Not available for sale in the US

9 Source: Adapted from Hermiller CRT 2011
Investigational Device only in the US; Not available for sale in the US

10 LV End Systolic Volume, Preliminary 24 Month Results Per Protocol Cohort, Matched Baseline to 12 Months p=0.0005 p=0.0255 Baseline (n=118) 12 Months (n=118) 24 Months (n=74) Baseline (n=65) 12 Months (n=65) 24 Months (n=36) Device Control LVESV = left ventricular end systolic volume p-value compares baseline to 12 month measurements based on matched cases Source: Adapted from Lim, S., TCT PML03372 Rev. A. Investigational Device only in the US; Not available for sale in the US

11 NYHA Functional Class, Preliminary 24 Month Results Per Protocol Cohort, Matched Baseline to 12 Months p<0.0001 p<0.0001 I I I I I I II 84% NYHA Class I & II II 100% NYHA Class I & II III 50% NYHA Class III & IV 45% NYHA Class III & IV II II III II II III III IV IV (n=124) (n=124) (n=77) (n=66) (n=66) (n=37) Device Control *p-value compares the distribution of NYHA functional class that occurs in the Device Group vs. the distribution of NYHA functional class that occurs in the Control groups at 12 months (Fishers’ Exact test) Investigational Device only in the US; Not available for sale in the US Source: Adapted from Lim, S., TCT PML03372 Rev. A.

12 ACCESS Europe Six Minute Walk Test Baseline and 6 & 12 Months
Baseline & 6 month 6MWT Matched Data (n = 86) Baseline & 12 month 6MWT Matched Data (n = 29) 66 m p = 61 m p < Source: Adapted from Maisano, ACESS Europe, San Raffaele University Hospital Investigational Device only in the US; Not available for sale in the US 12

13 Abbott Vascular Structural Heart Commitment to the Treatment of Mitral Valve Disease
Investigational Device only in the US; Not available for sale in the US

14 Multi-Disciplinary Team
Abbott Vascular Structural Heart Commitment to the Treatment of Mitral Valve Disease Global Multi-Disciplinary Team Patient Follow-up through 5 years Clinical Studies Patients Investigational Device only in the US; Not available for sale in the US

15 CAUTION: Investigational device limited by Federal (U. S
CAUTION: Investigational device limited by Federal (U.S.) law to investigational use only. CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, it is important to read the package insert thoroughly for Instructions for Use, Warnings and Potential Complications associated with use of this device. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Tests performed by and data on file at Abbott Vascular. All drawings are artist’s representations only and should not be considered as an engineering drawing or photograph. Photo(s) taken by and on file at Abbott Vascular. MitraClip is a trademark of the Abbott Group of Companies. © 2011 Abbott Laboratories. All rights reserved. PML3692 Rev. A (02/2011) Investigational Device only in the US; Not available for sale in the US


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