CRM88604 AA JUN 2012 HRS 2012 SICD Clinical

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CRM-88604 -AA JUN 2012 HRS 2012 S-ICD Clinical Highlights

CRM-88604 -AA JUN 2012 HRS 2012 S-ICD Clinical Highlights

The content in this presentation was presented at HRS, May 2012. This presentation is

The content in this presentation was presented at HRS, May 2012. This presentation is for educational purposes only and should not be copied or presented without the permission of Boston Scientific Corp. Like any other service, in spite of our best efforts the information in this presentation may become out of date over time. Nothing on this presentation should be construed as the giving of advice or the making of a recommendation and it should not be relied on as the basis for any decision or action. The materials are intended for educational purposes only. Boston Scientific neither assumes nor accepts liability for the accuracy or completeness or use of, nor any duty to update, the information contained in this presentation. Some information in this presentation describe products in development that will require approvals or clearances by FDA prior to market release. Some products may be investigational and limited by Federal law to investigational use. CRM-88604 -AA JUN 2012 Disclaimer

Table of Contents 1. Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD®): HRS

Table of Contents 1. Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD®): HRS Late Breaking Clinical Trials Presented by: Martin C. Burke, DO CRM-88604 -AA JUN 2012 2. International Experience with a Subcutaneous ICD; Preliminary Results of the EFFORTLESS S-ICD Registry Presented by: Pier D. Lambiase, MD, Ph. D HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD®) HRS Late Breaking Clinical Trials

Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD®) HRS Late Breaking Clinical Trials Professor of Medicine Interim Chief of Cardiology Director, Heart Rhythm Center University of Chicago Heart Rhythm - May 2012; LB 01 -6 Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Martin C. Burke, DO

Subcutaneous-ICD System Designed to sense, detect and treat malignant ventricular tachyarrhythmias CRM-88604 -AA JUN

Subcutaneous-ICD System Designed to sense, detect and treat malignant ventricular tachyarrhythmias CRM-88604 -AA JUN 2012 S-ICD System is entirely subcutaneous Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

S-ICD Study Design Prospective, Single-Arm Comparison to OPC Enrollment (N=330) • 33 Sites in

S-ICD Study Design Prospective, Single-Arm Comparison to OPC Enrollment (N=330) • 33 Sites in the US, NZ, NL, UK 1 o Efficacy Endpoint: Acute VF Conversion Rate • 2 consecutive successes out of 4 attempts • Lower Bound of 2 -sided CI 95% > 88% Optional Sub-Study • VF Conversion Rate at ≥ 150 Days • Lower Bound of 2 -sided CI 95% > 79% Semi-Annual Follow-Up Visits Through Study Close Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 1 o Safety Endpoint: 180 -Day System Complication Free Rate

Eligibility Inclusion Age ≥ 18 years Met guidelines for ICD implantation 3 or replacement

Eligibility Inclusion Age ≥ 18 years Met guidelines for ICD implantation 3 or replacement of an existing ICD system An appropriate pre-operative ECG Prior VT reliably terminated with anti-tachycardia pacing Existing epicardial patches or subcutaneous array Unipolar pacemakers Severe renal dysfunction (GFR ≤ 29) Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Key Exclusion Criteria

CRM-88604 -AA JUN 2012 S-ICD System IDE Study Results Burke, S-ICD, HRS 2012, Boston,

CRM-88604 -AA JUN 2012 S-ICD System IDE Study Results Burke, S-ICD, HRS 2012, Boston, MA

Patient Enrollment Patients Enrolled (N=330) Patients Withdrawn PRIOR to Implant (N=9) Implant Testing Not

Patient Enrollment Patients Enrolled (N=330) Patients Withdrawn PRIOR to Implant (N=9) Implant Testing Not Completed (N=17) • • Active Patients (N=294) Burke, S-ICD, HRS 2012, Boston, MA Implant Testing Completed EFFECTIVENESS COHORT (N=304) Not Discharged with System (N=7) Exits after Hospital Discharge (N=12) Deaths unrelated to device or procedure (N=7) Death unknown due to limited information from overseas death (N=1) CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Implant Attempts SAFETY COHORT (N=321)

Basic Patient Demographics Demographic Category Age (years) Male Value 52 ± 16 74% Height

Basic Patient Demographics Demographic Category Age (years) Male Value 52 ± 16 74% Height (cm) 174 ± 10 Weight (kg) 91 ± 25 BMI (kg/m 2) 30 ± 7 Caucasian 65% African American 24% Hispanic or Latino 7% Other 4% Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Race

Baseline Characteristics Co-morbidities History Cardiac Surgical History Burke, S-ICD, HRS 2012, Boston, MA Statistic/Category

Baseline Characteristics Co-morbidities History Cardiac Surgical History Burke, S-ICD, HRS 2012, Boston, MA Statistic/Category Congestive Heart Failure Hypertension Myocardial Infarction Diabetes Atrial Fibrillation Valve Disease COPD Stroke Percutaneous Revascularization CABG TV-ICD Valve Surgery Pacemaker n 197 187 133 90 49 42 27 18 92 48 43 18 4 % 61 58 41 28 15 13 8 6 29 15 13 6 1 CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Attribute N=321

Primary & Secondary Prevention Patient Distribution Similar to NCDR Registry S-ICD System IDE Study

Primary & Secondary Prevention Patient Distribution Similar to NCDR Registry S-ICD System IDE Study n=321 patients Secondary Prevention 21% Secondary Prevention 22% Primary Prevention 78% CRM-88604 -AA JUN 2012 Primary Prevention 79% NCDR ICD Registry n=486, 025 patients Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Baseline Characteristics Attribute NYHA Class at Enrollment n % Class I 68 21 Class

Baseline Characteristics Attribute NYHA Class at Enrollment n % Class I 68 21 Class II 146 45 Class III 55 17 Class IV 1 <1 Unknown/Not Assessed 51 16 Mean ± SD (Median) 36 ± 16 (31) CRM-88604 -AA JUN 2012 Ejection Fraction (%) (n=299) Statistic/Category N=321 Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

CRM-88604 -AA JUN 2012 Implant Success Burke, S-ICD, HRS 2012, Boston, MA CE Mark

CRM-88604 -AA JUN 2012 Implant Success Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Implant Attempts 321 patients underwent implant procedure 95% implanted using only anatomical landmarks (no

Implant Attempts 321 patients underwent implant procedure 95% implanted using only anatomical landmarks (no medical imaging) CRM-88604 -AA JUN 2012 No electrode or pulse generator movement in 99% of implanted patients throughout follow-up period Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

CRM-88604 -AA JUN 2012 Effectiveness Results Primary Effectiveness Endpoint Burke, S-ICD, HRS 2012, Boston,

CRM-88604 -AA JUN 2012 Effectiveness Results Primary Effectiveness Endpoint Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Primary Effectiveness Endpoint Analysis Cohort Acute Induction Testing Not Performed (N=1) Acute Induction Testing

Primary Effectiveness Endpoint Analysis Cohort Acute Induction Testing Not Performed (N=1) Acute Induction Testing Nonevaluable (N=16) Burke, S-ICD, HRS 2012, Boston, MA SAFETY COHORT/ Implant Attempts (N=321) Patients Withdrawn PRIOR to Implant (N=9) EFFECTIVENESS COHORT (N=304) CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Patients Enrolled (N=330)

Primary Effectiveness Endpoint Met Primary IDE Effectiveness Endpoint Hypothesis: Lower Bound of 2 -sided

Primary Effectiveness Endpoint Met Primary IDE Effectiveness Endpoint Hypothesis: Lower Bound of 2 -sided CI 95% >88% N=304 patients Non. Evaluable Patients 1 16 Evaluable Results Successful Failure 304 0 Conversion 95% Lower Rate (%) Bound (%) 100. 0 98. 8 CRM-88604 -AA JUN 2012 Induction Testing Not Performed Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Sensitivity Analysis Exceeds OPC Primary IDE Effectiveness Endpoint Hypothesis: Lower Bound of 2 -sided

Sensitivity Analysis Exceeds OPC Primary IDE Effectiveness Endpoint Hypothesis: Lower Bound of 2 -sided CI 95% >88% Sensitivity Analysis Failure: Patients w/ incomplete testing and ≥ 1 failed shock N=315 patients Induction Testing Not Performed Non. Evaluable Patients 1 16 304 0 100. 0 98. 8 1 5 304 11 96. 5 93. 8 Conversion 95% Lower Rate (%) Bound (%) CRM-88604 -AA JUN 2012 Evaluable Results Successful Failure Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

All Analyses Exceed OPC Primary IDE Effectiveness Endpoint Hypothesis: Lower Bound of 2 -sided

All Analyses Exceed OPC Primary IDE Effectiveness Endpoint Hypothesis: Lower Bound of 2 -sided CI 95% >88% Sensitivity Analysis Failure: Patients w/ incomplete testing and ≥ 1 failed shock Worst-Case Sensitivity All non-evaluable and 1 not tested deemed “Failures” N=321 patients Induction Testing Not Performed Non. Evaluable Patients 1 16 304 0 100. 0 98. 8 1 5 304 11 96. 5 93. 8 0 0 304 17 94. 7 91. 7 Burke, S-ICD, HRS 2012, Boston, MA Conversion 95% Lower Rate (%) Bound (%) CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Evaluable Results Successful Failure

Spontaneous Episodes VT/VF Episodes Total Discrete Storm Episodes 109 28 81 (4 events) Patients

Spontaneous Episodes VT/VF Episodes Total Discrete Storm Episodes 109 28 81 (4 events) Patients 16 16 2 Evaluation IDE Study CRM-88604 -AA JUN 2012 All episodes successfully converted with 80 J or spontaneously converted Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Unnecessary Therapy Avoided Algorithm prevents therapy for VT/VF rhythms that are likely to spontaneously

Unnecessary Therapy Avoided Algorithm prevents therapy for VT/VF rhythms that are likely to spontaneously terminate Therapy avoided in 63% of patients with VT/VF rhythms meeting criteria to charge without any reports of syncope 27 0% 20% 16 40% Non-Sustained (not shocked) Burke, S-ICD, HRS 2012, Boston, MA 60% 80% 100% Sustained (shocked) CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 VT/VF (Patients)

Example: Non-Sustained MVT Likely to receive therapy from TV-ICD CRM-88604 -AA JUN 2012 DURATION:

Example: Non-Sustained MVT Likely to receive therapy from TV-ICD CRM-88604 -AA JUN 2012 DURATION: 16 seconds 47 cycles Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

CRM-88604 -AA JUN 2012 Safety Results S-ICD System IDE Study Burke, S-ICD, HRS 2012,

CRM-88604 -AA JUN 2012 Safety Results S-ICD System IDE Study Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Safety Results Analysis Cohort Patients Enrolled (N=330) Burke, S-ICD, HRS 2012, Boston, MA CRM-88604

Safety Results Analysis Cohort Patients Enrolled (N=330) Burke, S-ICD, HRS 2012, Boston, MA CRM-88604 -AA JUN 2012 SAFETY COHORT/ Implant Attempts (N=321) Patients Withdrawn PRIOR to Implant Procedure (N=9) CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Primary Safety Endpoint Met 1. 0 0. 9 0. 8 180 -day Performance Goal

Primary Safety Endpoint Met 1. 0 0. 9 0. 8 180 -day Performance Goal (79%) 0. 7 Freedom 0. 6 from Type I Complication 0. 5 0. 4 0. 2 0. 1 0. 0 0 30 60 90 120 150 180 Post-op Days Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 180 -day Type I Complication-Free Rate: 99. 0% (97. 9% LCL) 0. 3

Freedom from all Device-, Labeling-, & Procedurerelated Complications 1. 0 0. 9 0. 8

Freedom from all Device-, Labeling-, & Procedurerelated Complications 1. 0 0. 9 0. 8 180 -day Performance Goal (79%) 0. 7 Freedom 0. 6 from Type I - III 0. 5 Complication 0. 4 0. 3 0. 2 0. 1 0. 0 0 30 60 90 120 150 180 Post-op Days Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 180 -day Device & Procedure-related Complication-free Rate: 92. 1% (88. 9% LCL)

CRM-88604 -AA JUN 2012 Safety Results Infections Burke, S-ICD, HRS 2012, Boston, MA CE

CRM-88604 -AA JUN 2012 Safety Results Infections Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Few Infections Led to Explant All Suspected & Confirmed Infections (N=18) Superficial or Incisional

Few Infections Led to Explant All Suspected & Confirmed Infections (N=18) Superficial or Incisional Infections Managed without System Explant (n=14, 4. 4%) Managed w/ antibiotics (n=13) Managed w/ sternal wound revision (n=1) Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 System Explanted (n=4, 1. 3%)

Infections: Study-Wide Learning on Surgical Prep 350 All 4 infections requiring explantation occurred early

Infections: Study-Wide Learning on Surgical Prep 350 All 4 infections requiring explantation occurred early in study enrollment 250 200 150 100 ENROLLMENTS 300 Burke, S-ICD, HRS 2012, Boston, MA Apr-11 Mar-11 Feb-11 Jan-11 Dec-10 Nov-10 Oct-10 Sep-10 Aug-10 Jun-10 May-10 Apr-10 Jul-10 4 0 0 CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Infections requiring explant Mar-10 Feb-10 Jan-10 50

CRM-88604 -AA JUN 2012 Safety Results Inappropriate Shocks Burke, S-ICD, HRS 2012, Boston, MA

CRM-88604 -AA JUN 2012 Safety Results Inappropriate Shocks Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Inappropriate Shocks 38 patients* experienced shocks due to non-VT/VF event 15 patients: SVT >

Inappropriate Shocks 38 patients* experienced shocks due to non-VT/VF event 15 patients: SVT > Discrimination zone 24 patients: Oversensing Rate of inappropriate therapy is consistent with current transvenous ICDs CRM-88604 -AA JUN 2012 No patients experienced a shock due to discrimination error in Conditional Shock (dual) zone * 1 patient experienced multiple events Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

Dual-zone Programming Reduced Inappropriate Shocks 14% 54% relative reduction 12% 10% 74% relative reduction

Dual-zone Programming Reduced Inappropriate Shocks 14% 54% relative reduction 12% 10% 74% relative reduction 8% 6% 2% 0% Single (n=88) Dual (n=226) Oversensing Burke, S-ICD, HRS 2012, Boston, MA Single (n=88) Dual (n=226) SVT CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 4%

International Experience with a Subcutaneous ICD; Preliminary Results of the EFFORTLESS S-ICD Registry PD

International Experience with a Subcutaneous ICD; Preliminary Results of the EFFORTLESS S-ICD Registry PD Lambiase Sponsor: Cameron Health, Inc. San Clemente, CA Heart Rhythm - May 2012; Vol 9: 5(S 1 -33) AB 07 -2. Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 DAMJ Theuns, C Barr, R Knops, F Murgatroyd, JB Johansen & L Boersma on behalf of the EFFORTLESS S-ICD investigators

S-ICD System is entirely subcutaneous and can be placed using anatomical landmarks Three sensing

S-ICD System is entirely subcutaneous and can be placed using anatomical landmarks Three sensing vectors to identify most robust cardiac signal Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA Single-zone programming allows therapy to be delivered solely on measured heart rate Dual-zone programming activates SVT discrimination algorithm to determine appropriateness of therapy CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 The S-ICD System Operation

Evaluation o. F Fact. ORs Affec. Ting the CLinical Outcome and Cost Effectivene. SS

Evaluation o. F Fact. ORs Affec. Ting the CLinical Outcome and Cost Effectivene. SS of the S-ICD – The EFFORTLESS S-ICD Registry Design International, standard of care Registry to collect short, mid and long-term operational and clinical outcome data on the Cameron Health S-ICD system • 5 year data post implant • Retrospective and prospective patients implanted since CE mark • Aiming to recruit up to 1000 patients • Centers to be included from all current commercial countries CRM-88604 -AA JUN 2012 • Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

The EFFORTLESS Registry Design Protocol includes • Documentation of system related outcomes and clinical

The EFFORTLESS Registry Design Protocol includes • Documentation of system related outcomes and clinical events • Prospective, Quality of Life sub-study to assess patients perception of their therapy Cost effectiveness analysis by hospital resource tracking and use of EQ-5 D questionnaire Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 • • Run by Tilburg University Core Lab- Professor Susanne Pedersen • SF-12, FPAS, ICDC, HADS, DS-14 & EQ-5 D QOL questionnaires • Baseline, 3, 6, 12 months post implant • Direct comparison to TV therapy via MIDAS study cohort

EFFORTLESS Registry Inclusion/Exclusion Criteria Inclusion Criteria • • ≥ 18 yrs* at time of

EFFORTLESS Registry Inclusion/Exclusion Criteria Inclusion Criteria • • ≥ 18 yrs* at time of consent Eligible for implantation of an S-ICD system per local clinical guidelines or currently implanted with an S-ICD Exclusion Criteria • • Participation in any other investigational study that may interfere with interpretation of the study results VT that is reliably terminated by ATP Unipolar pacemakers *Not applicable for centers enrolling under DN 15677, August 30, 2010 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 •

EFFORTLESS Registry Site Participation in 9 Geographies UK (13) NZ (2) SL(1) CZ (3)

EFFORTLESS Registry Site Participation in 9 Geographies UK (13) NZ (2) SL(1) CZ (3) P (1) DE (10) CRM-88604 -AA JUN 2012 NL (7) DK (3) I (4) Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

EFFORTLESS Registry Recruitment Overview 230 CZ (17) DK (14) NL (123) CRM-88604 -AA JUN

EFFORTLESS Registry Recruitment Overview 230 CZ (17) DK (14) NL (123) CRM-88604 -AA JUN 2012 UK (75) NZ (1) Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

EFFORTLESS Registry Patient Status as of April 27, 2012 Average FU 389± 282 days,

EFFORTLESS Registry Patient Status as of April 27, 2012 Average FU 389± 282 days, max 981 days Patients Enrolled (N=230) • Missing Data N=4 • Withdrawn due to ineligibility N=2 • Consented not implanted N=1 • • Active Patients (N =210) Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA Withdrawn N=1 (heart transplant) Deaths N=6* Explants N=5 Inactive N=1 * No device related deaths CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Patients Implanted (N =223)

EFFORTLESS Registry Demographic Category Value N 49± 19* (11 -86) 227 74 227 Height

EFFORTLESS Registry Demographic Category Value N 49± 19* (11 -86) 227 74 227 Height (cm) 175± 10 186 Weight (kg) 81± 20 196 42± 19 (35) 178 104± 21 207 Age (yrs; range) Male (%) LVEF (%; median) QRS (ms) *Approx. 60% of patients (131/227) ≥ 50 yrs Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Basic Patient Demographics

Standard ICD Baseline Characteristics Attribute Co-morbidities Cardiac Surgical History Statistic/Category Congestive Heart Failure Hypertension

Standard ICD Baseline Characteristics Attribute Co-morbidities Cardiac Surgical History Statistic/Category Congestive Heart Failure Hypertension Myocardial Infarction Diabetes Renal Disease Atrial Fibrillation COPD Stroke Ablation CABG Valve Surgery Prior TV ICD Pacemaker N=223 % 32 25 38 13 10 19 6 4 7 10 6 15* 3* 37 patients had previously implanted systems- 6 patients have concomitant PM/S-ICD Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 EFFORTLESS Registry

EFFORTLESS Registry Heart Failure & Indication Characteristics NYHA Class at Enrollment Statistic/Category n %

EFFORTLESS Registry Heart Failure & Indication Characteristics NYHA Class at Enrollment Statistic/Category n % Class I 19 27 Class II 32 46 Class III 10 14 Class IV 0 0 Unknown/Not Assessed 9 13 Indication Primary Secondary Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA n % 144 64 81 36 CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Attribute N=70

EFFORTLESS Registry Broad Range of ICD Indications CRM-88604 -AA JUN 2012 Patients from a

EFFORTLESS Registry Broad Range of ICD Indications CRM-88604 -AA JUN 2012 Patients from a broad range of indications have received the S-ICD Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

EFFORTLESS Registry Cardiac Medications at Enrollment Medication 151 11 48 33 % 7 41

EFFORTLESS Registry Cardiac Medications at Enrollment Medication 151 11 48 33 % 7 41 41 67 5 21 15 CRM-88604 -AA JUN 2012 Amiodarone Diuretics ACE Inhibitors Beta Blockers Digoxin Lipid Lowering (incl. statins) None n 15 93 93 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

CRM-88604 -AA JUN 2012 Registry Results Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA

CRM-88604 -AA JUN 2012 Registry Results Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

EFFORTLESS Registry Effective Conversion of Induced VT/VF Patient Data n Implant Conversion test data

EFFORTLESS Registry Effective Conversion of Induced VT/VF Patient Data n Implant Conversion test data available 204 Successful conversion within 1 procedure 201 -Successful at 65 J -Successful at 80 J Patients requiring repositioning 1 2 98. 5 1. 5 CRM-88604 -AA JUN 2012 -Successful conversion following repositioning -Awaiting retesting (non inducible) 197 201 % Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

EFFORTLESS Registry 93% of Events Treated in < than 21 secs 93% <21 seconds

EFFORTLESS Registry 93% of Events Treated in < than 21 secs 93% <21 seconds 40 37. 2% % of Events 35 N=86* 34. 9% Mean ± SD: Median: 30 15. 9± 3. 8 15. 0 25 17. 4% 20 15 10 0 3. 5% <12 3. 5% 12 -14. 9 15 -17. 9 18 -20. 9 21 -23. 9 3. 5% ≥ 24 Seconds *No data available for retrospective patients Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 5

EFFORTLESS Registry 100% Conversion of Spontaneous VT/VF • 16 discrete VT/VF episodes from 11

EFFORTLESS Registry 100% Conversion of Spontaneous VT/VF • 16 discrete VT/VF episodes from 11 patients EPISODES Discrete Episodes Patients Type II spontaneous Termination 16 11 2 1 st S-ICD System Shock Conversion 2 nd S-ICD System Shock Conversion 13 1 • 32 VT/VF storm episodes from 2 patients both with electrolyte imbalances (post dialysis and post surgery) Storm Events Episodes Patients S-ICD System Shock Conversion 4 32 2 32 (100%) Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 EPISODES

EFFORTLESS Registry Annual Inappropriate Shock Rate of 7% • 15 patients received inappropriate shocks

EFFORTLESS Registry Annual Inappropriate Shock Rate of 7% • 15 patients received inappropriate shocks (7%) • No inappropriate shocks have been recorded for AF/SVT within a programmed conditional shock zone 15 10 5 7% 0 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA Rate > Shock Zone Oversensing CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Percent 20

EFFORTLESS Registry Appropriate vs. Inappropriate Episodes Total of 72 Episodes 60 40 30 20

EFFORTLESS Registry Appropriate vs. Inappropriate Episodes Total of 72 Episodes 60 40 30 20 (67%) (28%) 10 0 Appropriate Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA Inappropriate Episode not stored CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Episodes 50

EFFORTLESS Registry Clinical Event Definitions • Clinical Event • Any untoward medical occurrence •

EFFORTLESS Registry Clinical Event Definitions • Clinical Event • Any untoward medical occurrence • Categories • • Complications: Observations: Invasive intervention required Conservative therapy required • Type I-III Clinical Events • Device-, labeling-, or procedure-related • Type IV Clinical Events Related to patient condition CRM-88604 -AA JUN 2012 • Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

EFFORTLESS Registry Device & Procedure-Related Events Category Complications Observations Device-related (Type I) 2 16

EFFORTLESS Registry Device & Procedure-Related Events Category Complications Observations Device-related (Type I) 2 16 Labeling-related (Type II) 0 0 15 19 Procedure-related (Type III) Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CRM-88604 -AA JUN 2012 17 CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

EFFORTLESS Registry Device-Related Events - Type I Category Complications Observations 1 14 Discomfort 0

EFFORTLESS Registry Device-Related Events - Type I Category Complications Observations 1 14 Discomfort 0 1 Premature battery depletion 1 0 Inability to communicate with device 0 1 Total 2 16 CRM-88604 -AA JUN 2012 Inappropriate Shock - oversensing Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

EFFORTLESS Registry Procedure-Related Events - Type III Complications Observations Infection/suspicion of infection 6 2

EFFORTLESS Registry Procedure-Related Events - Type III Complications Observations Infection/suspicion of infection 6 2 Inappropriate Shock - rate > shock zone 1 5 Suboptimal electrode position 5 0 Hematoma 1 2 Redness/irritation 0 3 Discomfort 0 2 Keloid formation 0 1 Phantom shocks/vibration 0 3 Transfusion 1 0 PG Movement/Revision 1 0 15 19 Total Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 Category

EFFORTLESS Registry Infection Management Medically Managed without System Explant (n=3, 1. 3%) *No reported

EFFORTLESS Registry Infection Management Medically Managed without System Explant (n=3, 1. 3%) *No reported endocarditis or blood born infection Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA Electrode Explanted (n=1, 0. 4%) System Explanted (n=4, 1. 8%) Electrode Re-implant (n=1) S-ICD Re-implant (n=1) CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale. CRM-88604 -AA JUN 2012 All Suspected Infections* (N=8)