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Baroreflex Activation ™ Therapy for Heart Failure Study Steering Committee: 1 MD , William T. Abraham, JoAnn Lindenfeld, 2 MD Fred A. Weaver, 1 Division 3 MD , Faiez Zannad, 4 MD , Michael R. Zile, 5 MD 2 Vanderbilt of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA; Heart and Vascular Institute, Nashville, TN, USA; 3 Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 4 Inserm Centre d'Investigation, CHU de Nancy, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France; 5 Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA The BAROSTIM NEO ™ System Background • Heart failure is characterized by a hyperadrenergic state with suppressed parasympathetic tone and secondary deleterious neurohormonal effects • Despite improved guideline adherence and targeted medical therapy, outcomes in reduced-ejection fraction heart failure (HFrEF) remain unsatisfactory • BAROSTIM THERAPY™ is a unique treatment option for HFrEF that delivers electrical stimulation to the carotid sinus to activate the baroreflex and reduce sympathetic activity while restoring parasympathetic activity • Phase 1 (n=11) and Phase 2 (n=146) studies of BAROSTIM THERAPY in HFrEF patients have demonstrated that chronic baroreflex activation significantly1,2: • Improves autonomic balance and reduces neurohormonal activation • Improves six minute hall walk (6MHW), Minnesota Living With HF Quality of Life (MLWHF) and NYHA functional class • Reduces heart failure hospitalization burden Implantable Pulse Generator (IPG) Implanted under the skin below the collarbone. Provides control and delivery of activation energy from the IPG to the baroreceptors on the carotid artery. Carotid Sinus Lead One thin lead wire implanted on the carotid artery and connected to the device. Conducts activation energy from the IPG to the baroreceptors on the carotid artery. Key Eligibility Criteria Inclusion Wireless Programmer System • Symptomatic NYHA Class III • Left ventricular ejection fraction ≤ 35% An external system used to adjust and customize therapy settings via wireless communication. • Heart failure defined as: • BNP≥ 400 or NT-proBNP ≥ 1600 OR • BNP ≥ 100 or NT-proBNP ≥400 AND prior hospitalization for heart failure within 12 months. • On optimal, stable, Guideline Directed Medical Therapy for the treatment of heartfailure Relevant Clinical Experience Study Design & Objectives In non-CRT patients, results at six months showed that symptoms, functional capacity, and cardiovascular function were significantly improved, while heart failure hospitalization days were reduced in those who received Baroreflex Activation Therapy (BAT) compared to those in the control arm (BAT n=47; Control n=48) 3 The BAROSTIM NEO device for this study patient population has received Expedited Access Pathway designation from FDA4. This designation is for medical devices that demonstrate the potential to address unmet medical needs for patients with life threatening or irreversibly debilitating diseases. Improvement in intermediate endpoints, which is of value to these patients, has been incorporated into the study design to support evaluation of safety and efficacy. Improves Quality of Life (Minnesota Living with Heart Failure) 60 40 IMPROVEMENT 82 meters p=0.003 4 0 -5 -10 -15 -20 Center Requirements • Large heart failure population • Large cardiology practice • Strong collaboration with vascular surgery • Electronic medical records • Prior experience with randomized device studies -22 IMPROVEMENT 25 points p<0.001 Centers interested in participating in BeAT-HF should contact Liz Galle, Senior Director of Clinical Research: [email protected] 20 -25 4 0 -30 Control BAT • Heart failure secondary to a reversible cause • Dedicated research coordinator Improvement 86 80 • AHA/ACC Stage D heart failure • Significant patient recruitment in previous heart failure studies 5 ← 100 6 Month Change from Baseline Points 10 Improvement → 6 Month Change from Baseline Meters 120 • Currently implanted with, or currently have, a Class 1 indication according to AHA/ACC guidelines for a cardiac resynchronization therapy device • Known or suspected baroreflex failure or autonomic neuropathy • Six-minute hall walk ≥ 150 m AND ≤ 400 m • BAROSTIM THERAPY is particularly effective in patients who are not eligible for cardiac resynchronization therapy (CRT), a population in need of new therapeutic options Improves Six Minute Hall Walk Distance Exclusion BAT Control References Reduces NT-pro BNP Improves Left Ventricular Ejection Fraction 6 200 0 116 -97 -200 -400 1 5 4 3 2 1 Improvement → 400 IMPROVEMENT 318 pg/mL p=0.03 Improvement 600 6 Month Change from Baseline % 800 ← 6 Month Change from Baseline median pg/mL 1000 4.3 IMPROVEMENT 4.4 Percentage Points p=0.03 0 -0.1 -600 -1 -800 -2 BAT Control BAT Control 2 Safety: • Event-free rate of all system- and procedure-related Major Adverse Neurological and Cardiovascular Events occurring within 6 months post-implant Efficacy: • Six Minute Hall Walk, Minnesota Living with Heart Failure Quality of Life, NT-proBNP • Cardiovascular mortality and worsening heart failure (M&M) 3 4 Gronda E et al., European Journal of Heart Failure. 2014;16:977–983 Abraham WT et al., JACC: Heart Failure. 2015; 3:487-496 Zile MR et al., European Journal of Heart Failure. 2015;17:1066–1074. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddevgen/documents/document/ucm393978.pdf The BAROSTIM NEO system is CE Marked and approved for sale for heart failure patients in Europe. It is also CE Marked and approved for sale for hypertension patients in Europe. Caution: BAROSTIM NEO is an investigational device and is limited by United States law to investigational use. CVRx, BAROSTIM NEO, Baroreflex Activation Therapy and BAROSTIM THERAPY are all trademarks of CVRx, Inc. © 2016 CVRx, Inc. All rights reserved.