Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. Robert C. Bourge COMPASS-HF

www. Clinical trial results.org Endpoints (mean follow-up 6 months):  Primary: Safety (freedom from system-related complications and sensor lead failure) and Efficacy (heart failure related hospitalizations, emergency department and urgent clinic visits requiring intravenous intervention)  Secondary: Heart failure related hospitalizations Endpoints (mean follow-up 6 months):  Primary: Safety (freedom from system-related complications and sensor lead failure) and Efficacy (heart failure related hospitalizations, emergency department and urgent clinic visits requiring intravenous intervention)  Secondary: Heart failure related hospitalizations COMPASS-HF Presented at ACC Scientific Sessions patients having class III or IV heart failure (despite treatment with standard medical therapy) and at least one heart failure related hospitalization Randomization was stratified by LVEF < or ≥ 50%. Mean age 58 years. 35% female. 274 patients having class III or IV heart failure (despite treatment with standard medical therapy) and at least one heart failure related hospitalization Randomization was stratified by LVEF < or ≥ 50%. Mean age 58 years. 35% female. Blocked clinician access Control n=140 Blocked clinician access Control n=140 Total clinician access Monitored n=134 Total clinician access Monitored n=134

www. Clinical trial results.org Presented at ACC Scientific Sessions 2005 Primary Composite Endpoint: heart failure related hospitalizations, emergency department and urgent clinic visits requiring intravenous intervention COMPASS-HFCOMPASS-HF Intravenous intervention was required in 74 patients in the monitored group and 102 patients in the control group, resulting in a 22% non-significant reductionIntravenous intervention was required in 74 patients in the monitored group and 102 patients in the control group, resulting in a 22% non-significant reduction Groups well balanced, with 85% of patients in New York Heart Association class III heart failureGroups well balanced, with 85% of patients in New York Heart Association class III heart failure The main component of the primary endpoint, heart failure hospitalizations, occurred less frequently in the monitored group (RR 0.79, p=0.029)The main component of the primary endpoint, heart failure hospitalizations, occurred less frequently in the monitored group (RR 0.79, p=0.029) p=0.27

www. Clinical trial results.org Presented at ACC Scientific Sessions 2005 The clinical composite score had a higher rate of improvement in the monitored group (46% vs 35%) and a lower rate of worsening (34% vs 51%)The clinical composite score had a higher rate of improvement in the monitored group (46% vs 35%) and a lower rate of worsening (34% vs 51%) Rate of improvement Rate of worsening COMPASS-HFCOMPASS-HF Clinical Composite Score P=0.035

www. Clinical trial results.org Presented at ACC Scientific Sessions 2005 In the subgroup analysis of patients with NYHA Class III CHF, the primary composite endpoint was significantly lower in the monitored group than in the control group (RR 0.90, p=0.03)In the subgroup analysis of patients with NYHA Class III CHF, the primary composite endpoint was significantly lower in the monitored group than in the control group (RR 0.90, p=0.03) Additionally, heart failure hospitalization was lower in the monitored group (RR 0.76, p=0.023)Additionally, heart failure hospitalization was lower in the monitored group (RR 0.76, p=0.023) COMPASS-HFCOMPASS-HF Subgroup Analysis: patients with NYHA class III p=0.03

www. Clinical trial results.org Among patients with NYHA class III or IV heart failure, use of the implantable hemodynamic monitor system for specialized heart failure care management was associated with a non-significant reduction in the primary endpoint of heart failure related hospitalizations, emergency department and urgent clinic visits requiring intravenous intervention compared with heart failure care management without information from the implantable hemodynamic monitor system.Among patients with NYHA class III or IV heart failure, use of the implantable hemodynamic monitor system for specialized heart failure care management was associated with a non-significant reduction in the primary endpoint of heart failure related hospitalizations, emergency department and urgent clinic visits requiring intravenous intervention compared with heart failure care management without information from the implantable hemodynamic monitor system. Use of the monitor was associated with a significant reduction in heart failure hospitalizations. These improvements were observed despite treatment with optimal medical therapy in both groups.Use of the monitor was associated with a significant reduction in heart failure hospitalizations. These improvements were observed despite treatment with optimal medical therapy in both groups. Benefit was particularly evident in patients with NYHA class III heart failure. The reduction in heart failure related hospitalizations associated with the monitored group has the potential to reduce the high cost of therapy for these patients.Benefit was particularly evident in patients with NYHA class III heart failure. The reduction in heart failure related hospitalizations associated with the monitored group has the potential to reduce the high cost of therapy for these patients. Presented at ACC Scientific Sessions 2005 COMPASS-HFCOMPASS-HF