EBR Systems, Inc. 686 W. Maude Ave., Suite 102 Sunnyvale, CA USA

Transcription

1 Over 200,000 patients worldwide are estimated to receive a CRT device each year. However, limitations prevent some patients from benefiting. CHALLENGING PROCEDURE 5% implanted patients fail to have coronary sinus (CS) lead in a single procedure 1,2,3 EFFICACY RATE 30% patients who receive a CRT device don t benefit from treatment 4,5,6 EBR Systems, Inc. 686 W. Maude Ave., Suite 102 Sunnyvale, CA USA POST IMPLANT COMPLICATIONS 10% patients experience CS lead complications including lead dislodgements and phrenic nerve stimulation 1,2,7,8,9 UPGRADES 23% patients who receive a CRT device already have a conventional pacemaker or ICD implanted 10. Studies demonstrated a higher risk (18.7%) developing major complications during an upgrade to a CRT system EBR Systems, Inc. All Rights Reserved. WiSE is a trademark EBR Systems, Inc. Caution: Not commercially available in the United States PATIENTS THAT MAY BENEFIT Patients who have not responded to CRT Patients with an acute or chronic CS lead issue Patients with known risk associated with a CRT upgrade 1. Leon AR, Abraham WT, Curtis AB, et al. Safety Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart Failure: Combined Results Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: Gras D, Bocker D et al. Implantation cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety Europace (2007) 9, Al-Majed NS, McAlister FA, Bakal JA, Ezekowitz JA. Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart failure. Ann Intern Med 2011;154: Martin DO, Lemke B, et al., Investigation a novel algorithm for synchronized left ventricular pacing and ambulatory optimization cardiac resynchronization therapy: Results the adaptive CRT trial. HRS 2012 Volume 9, Issue 11, Pages e1. 5. Chung ES, Leon AR, et al., Results the Predictors Response to CRT (PROSPECT) Trial. Circulation. 2008;117: McAlister FA, Ezekowitz J, Hooton, N, et al. Cardiac Resynchronization Therapy for Patients with Left Ventricular Systolic Dysfunction: A Systematic Review. JAMA. 2007; 297(22): Abraham WT, Fisher WG, Smith AL, et al. Cardiac Resynchronization in Chronic Heart Failure. N Engl J Med. 2002; 346: Linde C, Abraham WT, et al. Randomized Trial Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, Tang SL, Wells GA, et al. Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure. NEJM 2010;363: Brignole M, Auricchio A, et al ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. European Heart Journal (2013) 34, Poole JE, Gleva MJ, et al. Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures Results From the REPLACE Registry. Circulation. 2010;122: van Deursen C, van Geldorp I, Rademakers L. et al. Left Ventricular Endocardial Pacing Improves Resynchronization Therapy in Canine Left Bundle-Branch Hearts. Circ Arrhythmia Electrophysiol. 2009; 2: Bracke FA, van Gelder BM, Dekker LRC, Woorst JF, Teijink JA. Left Ventricular Endocardial Pacing in Cardiac Resynchronization Therapy: Moving from Bench to Bedside. Neth Heart J. 2012; 20(3): Reddy VY, et al. Abstract LBCT Wireless LV Endocardial Stimulation for CRT: Primary Results the Safety and Performance Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015; Boston, Massachusetts. 15. Reddy VY, Neuzil P, et al. Presentation Wireless LV Endocardial Stimulation for CRT: Primary Results the Safety and Performance Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015; Boston, Massachusetts. 16. Leon AR, Abraham WT, Curtis AB, et al. Safety Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart Failure: Combined Results Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: Linde C, Abraham WT, et al. Randomized Trial Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, Young JB, Abraham WT, et al. Combined Cardiac Resynchronization and Implantable Cardioversion Defibrillation in Advanced Chronic Heart Failure, The MIRACLE ICD Trial. JAMA. 2003;289(20): MC Rev. A WIRELESS LV ENDOCARDIAL PACING New Hope for Heart Failure CRT Patients Caution: Not commercially available in the United States

2 HOW IT WORKS CLINICAL RESULTS The WiSE CRT System is designed to overcome the limitations traditional CRT pacing. It provides wireless, left ventricular (LV), endocardial pacing in patients with issues related to standard epicardial coronary sinus (CS) pacing leads. CO-IMPLANT DEVICE P A C E S Receiver Electrode 97% patients achieved implantation success (N=35) 97% patients who failed conventional CRT achieved cardiac resynchronization at 1-month (N=34) WIRELESS Leadless LV Stimulation Designed to eliminate lead complications. 3 paces by converting the ultrasound energy into electrical energy LV EF% End Systolic Volume QRS Duration to RV only Intrinsic BiV NYHA ENDOCARDIAL More Physiological Pacing Stimulates from the inside the left ventricle. Endocardial pacing is considered more physiological delivering improved electrical and haemodynamic response. 1 12,13,14 CUSTOMIZED Freedom in LV Positioning LV site selection the stimulation location; designed to enable tailored therapy to meet individual patient needs. LENGTH OF BODY 9.1mm DIAMETER 2.7mm TRANSMITTER RECEIVER ELECTRODE D E T E C T S 2 Transmitter detects the RV pacing pulse from the co-implant TRANSMITS Transmitter transmits ultrasound energy to the Receiver Electrode BATTERY All in as little as2 milliseconds! 10 Select-LV: 69.5% pts 5% increase (N=23) % patients experienced persistent clinical benefits at 6-months (N=24) Select-LV: 64.7% pts 15% improvement in LVESV (N=17) Select-LV Prospect 5 Miracle 16 Reverse 17 Miracle-ICD SELECT-LV: QRS decrease 53 ms (184 to 131 ms or 29% reduction, N=23) The SELECT-LV study showed sustained cardiovascular improvement for complex CRT patients treated with the WiSE System 0 Composite Global Score (Mortality, HF Hosp, NYHA, QOL) SELECT-LV: 61.5% pts 1 class improvement in functional capability (N=26) Worsened Unchanged Improved

3 WIRELESS LV ENDOCARDIAL PACING New Hope for Heart Failure CRT Patients Caution: Not commercially available in the United States

4 Over 200,000 patients worldwide are estimated to receive a CRT device each year. However, limitations prevent some patients from benefiting. CHALLENGING PROCEDURE 5% implanted patients fail to have coronary sinus (CS) lead in a single procedure 1,2,3 EFFICACY RATE POST IMPLANT COMPLICATIONS UPGRADES 30% 10% 23% patients who receive a CRT device don t benefit from treatment 4,5,6 patients experience CS lead complications including lead dislodgements and phrenic nerve stimulation 1,2,7,8,9 patients who receive a CRT device already have a conventional pacemaker or ICD implanted 10. Studies demonstrated a higher risk (18.7%) developing major complications during an upgrade to a CRT system 11. PATIENTS THAT MAY BENEFIT Patients who have not responded to CRT Patients with an acute or chronic CS lead issue Patients with known risk associated with a CRT upgrade

5 The WiSE CRT System is designed to overcome the limitations traditional CRT pacing. It provides wireless, left ventricular (LV), endocardial pacing in patients with issues related to standard epicardial coronary sinus (CS) pacing leads. WIRELESS Leadless LV Stimulation Designed to eliminate lead complications. ENDOCARDIAL More Physiological Pacing Stimulates from the inside the left ventricle. Endocardial pacing is considered more physiological delivering improved electrical and haemodynamic response. 12,13,14 LENGTH OF BODY 9.1mm DIAMETER 2.7mm CUSTOMIZED Freedom in LV Positioning LV site selection the stimulation location; designed to enable tailored therapy to meet individual patient needs.

6 HOW IT WORKS CO-IMPLANT DEVICE 3 P A C E S Receiver Electrode paces by converting the ultrasound energy into electrical energy RECEIVER ELECTRODE 2 TRANSMITS Transmitter transmits ultrasound energy to the Receiver Electrode 1 D E T E C T S Transmitter detects the RV pacing pulse from the co-implant BATTERY TRANSMITTER All in as little as2 milliseconds!

7 CLINICAL RESULTS 97% patients achieved implantation success (N=35) 97% patients who failed conventional CRT achieved cardiac resynchronization at 1-month (N=34) LV EF% End Systolic Volume QRS Duration to NYHA RV only Intrinsic BiV Select-LV: 69.5% pts 5% increase (N=23) Select-LV: 64.7% pts 15% improvement in LVESV (N=17) SELECT-LV: QRS decrease 53 ms (184 to 131 ms or 29% reduction, N=23) SELECT-LV: 61.5% pts 1 class improvement in functional capability (N=26) The SELECT-LV study showed sustained cardiovascular improvement for complex CRT patients treated with the WiSE System Composite Global Score (Mortality, HF Hosp, NYHA, QOL) 81% patients experienced persistent clinical benefits at 6-months (N=24) Select-LV Prospect 5 Miracle 16 Reverse 17 Miracle-ICD 18 Worsened Unchanged Improved

8 EBR Systems, Inc. 686 W. Maude Ave., Suite 102 Sunnyvale, CA USA EBR Systems, Inc. All Rights Reserved. WiSE is a trademark EBR Systems, Inc. Caution: Not commercially available in the United States 1. Leon AR, Abraham WT, Curtis AB, et al. Safety Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart Failure: Combined Results Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: Gras D, Bocker D et al. Implantation cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety Europace (2007) 9, Al-Majed NS, McAlister FA, Bakal JA, Ezekowitz JA. Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart failure. Ann Intern Med 2011;154: Martin DO, Lemke B, et al., Investigation a novel algorithm for synchronized left ventricular pacing and ambulatory optimization cardiac resynchronization therapy: Results the adaptive CRT trial. HRS 2012 Volume 9, Issue 11, Pages e1. 5. Chung ES, Leon AR, et al., Results the Predictors Response to CRT (PROSPECT) Trial. Circulation. 2008;117: McAlister FA, Ezekowitz J, Hooton, N, et al. Cardiac Resynchronization Therapy for Patients with Left Ventricular Systolic Dysfunction: A Systematic Review. JAMA. 2007; 297(22): Abraham WT, Fisher WG, Smith AL, et al. Cardiac Resynchronization in Chronic Heart Failure. N Engl J Med. 2002; 346: Linde C, Abraham WT, et al. Randomized Trial Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, Tang SL, Wells GA, et al. Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure. NEJM 2010;363: Brignole M, Auricchio A, et al ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. European Heart Journal (2013) 34, Poole JE, Gleva MJ, et al. Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures Results From the REPLACE Registry. Circulation. 2010;122: van Deursen C, van Geldorp I, Rademakers L. et al. Left Ventricular Endocardial Pacing Improves Resynchronization Therapy in Canine Left Bundle-Branch Hearts. Circ Arrhythmia Electrophysiol. 2009; 2: Bracke FA, van Gelder BM, Dekker LRC, Woorst JF, Teijink JA. Left Ventricular Endocardial Pacing in Cardiac Resynchronization Therapy: Moving from Bench to Bedside. Neth Heart J. 2012; 20(3): Reddy VY, et al. Abstract LBCT Wireless LV Endocardial Stimulation for CRT: Primary Results the Safety and Performance Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015; Boston, Massachusetts. 15. Reddy VY, Neuzil P, et al. Presentation Wireless LV Endocardial Stimulation for CRT: Primary Results the Safety and Performance Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015; Boston, Massachusetts. 16. Leon AR, Abraham WT, Curtis AB, et al. Safety Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart Failure: Combined Results Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: Linde C, Abraham WT, et al. Randomized Trial Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, Young JB, Abraham WT, et al. Combined Cardiac Resynchronization and Implantable Cardioversion Defibrillation in Advanced Chronic Heart Failure, The MIRACLE ICD Trial. JAMA. 2003;289(20): MC Rev. A