MitraClip World Wide Commercial Experience
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1 MitraClip World Wide Commercial Experience Valves Repaired. Lives Improved. Carlos G. Hernandez, MBA Sr. Product Manager, Strategic Planning Abbott Vascular October, 2014
2 MitraClip Transcatheter Mitral Valve Repair Based on Alfieri Stitch surgical procedure Establishes leaflet coaptation by capturing and drawing them together 2
3 System Components Steerable Guide Catheter 24 French steerable catheter Percutaneous venous access Clip Delivery System Contains the implant attached to a highly maneuverable delivery catheter with all controls at the proximal end MitraClip Device (Implant) Cobalt chromium construction Polyester cover designed to promote tissue growth Magnetic resonance conditional to 3 Tesla* *Static magnetic field up to 3 Tesla; maximum spatial gradient in static field of 2500 gauss/cm or less; maximum whole-body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning. 3
4 MitraClip Procedure Transfemoral delivery of implant via transseptal access to LA Stable intra-procedural hemodynamics Real time efficacy Permanent implant 4
5 Procedure Imaging MitraClip Procedure is Driven by Echocardiography Echocardiography (Primary Imaging) Fluoroscopy (Secondary Imaging) See Important Safety Information Referenced Within 5
6 Clinical Development EVEREST I: 55 patients EVEREST II RCT 3 : 279 Patients EII High Risk: 78 Patients REALISM Non-High Risk: 272 Patients REALISM High Risk: 625 Patients COAPT: Enrolling FMR Patients ACCESS EU: Patients 1. As of 02//28/2014 includes worldwide commercial and clinical procedures. Source: Abbott Vascular Data on File. 2. First-time procedures only 3. Of the 184 patients randomized to Device, 178 received Device. Of the 95 patients randomized to Control, 80 underwent mitral valve surgery. 60 roll-in patients. 4. Includes 25 PR DMR patients from the EVEREST II High-Risk Registry and 102 PR DMR patients from EVEREST II REALISM High Risk (including 4 Compassionate Use PR DMR patients) See Important Safety Information Referenced Within 6
7 Worldwide Experience Study Population N* Clinical Trials (EVEREST I II) Feasibility & RCT 377 Continued Access Registries (REALISM, ACCESS, Compassionate/Emergency Use) Non-randomized patients 1,818 Commercial Use Commercial patients 14,232 Total World Wide MitraClip Patients Treated 16,427 *Data as of 8/31/2014. Source: Abbott Vascular 7
8 Sep-08 Oct-08 Nov-08 Dec-08 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 Jan-10 Feb-10 Mar-10 Apr-10 May-10 Jun-10 Jul-10 Aug-10 Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 Implantation Procedures Global Commercial MitraClip Implant Experience Treating Centers 400+ Patients 1 15,085 Implant Rate 1 96% World Wide Experience MitraClip Procedures Etiology DMR % Mixed % FMR % US Commercial US CALA APAC Emerging Europe Western Europe 1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients 2. Etiology not inclusive of U.S. cases as of 04/14/2014 *Data as of 8/31/2014. Source: Abbott Vascular 8
9 Volume ml HF Hospitalization Rate per Patient Year MitraClip Clinical Evidence Reduction of mitral regurgitation Hospitalizations for Heart Failure % Reduction Reduction 0.6 in the rate of hospitalization 0.4 for heart failure III Improvement IV in NYHA functional class Positive safety profile I II Year Prior to MitraClip Left Ventricular End Diastolic Volume Left Ventricular Volumes -16 ml LV remodeling 40 1 Year Post Discharge Left Ventricular End Systolic Volume Reverse ml 46 Paired Data 60 0 Baseline (N = 69) 1 Year 30 0 Baseline (N=69) 1 Year Prohibitive Surgical Risk DMR Cohort (n=127) Source: MitraClip Clip Delivery System Instructions for Use. See important safety information referenced within. 9
10 Successful Patient Outcomes and Hospital Benefit 73% Low hospital length of stay 1,2 87% of MitraClip patients discharged to home 2 Majority of MitraClip patients discharged to home with or without home health care (9% to nursing home/skilled nursing facility, 4% died prior to discharge) 73% reduction in hospitalization rate 3 1 MitraClip Clip Delivery System Summary of Safety and Effectiveness Data (SSED) 2 Data on file at Abbott Vascular. 3 MitraClip Clip Delivery System Instructions for Use. 10
11 Patient Selection A Multidisciplinary Team Approach Multidisciplinary Heart Team Interventional Cardiology Echo Cardiology Anatomic patient characteristics should be considered The primary regurgitant jet is non-commissural, if a secondary jet exists, it must be considered clinically insignificant Mitral valve area 4.0cm 2 Minimal calcification in the grasping area No leaflet cleft in the grasping area Flail width <15mm and flail gap <10mm LVEF >20% or LVESD <60mm Heart Failure Specialist Cardiac Surgery PMVR is contraindicated for the following conditions Patients who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen Active endocarditis of the mitral valve Rheumatic mitral valve disease Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus 11
12 1-Clip Device Time (minutes) Learning Curve 100 MitraClip Device Time* by Case Volume Experience ~40% Reduction Case Volume Experience *Data courtesy of Abbott Vascular hospital commercial experience in 1-Clip device times from Sept Abbott to Sept. Vascular 2013 All rights reserved 12
13 MitraClip Current Asia Adoption and Future Expansion Asia Adoption Patients Hong Kong 38 Indonesia 24 Malaysia 30 Singapore 84 Future Expansion China Japan Philippines Taiwan Thailand Korea Vietnam 13
14 Summary MitraClip is a first in class TMVR technology Extensive clinical trial and real world experience with over 16,500 patients Reduction in MR, symptom improvement, and reductions in re-hospitalizations Committed to bringing technology to Asia 14
15 Thank You Abbott Vascular 3200 Lakeside Dr. Santa Clara, CA USA, EVEREST I, EVEREST II, REALISM, and ACCESS-EU are Abbott Vascular sponsored studies. Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use at for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. MitraClip is a registered trademark of the Abbott Group of Companies.
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