Cvrx, Inc. · NASDAQ:CVRX
Cvrx — Technical Presentation (May 2013)
16 slides from Cvrx's technical presentation, May 2013
Slide 1: Barostim neo System: 2nd Generation Device for Hypertension
Barostim neo™ System 2nd Generation Device for Hypertension Professor Peter de Leeuw University Hospital Maastricht, Netherlands CAUTION: The Rheos® Rheos® System is an investigational device and is limited by Federal (or (or United States) law to investigational use. Note: The Barostim neo is CE Ma
Slide 2: Presenter Disclosure Information
Presenter Disclosure Information Dr. Peter de Leeuw DISCLOSURE INFORMATION: The following relationships exist related to this presentation: CVRx Honorarium for presentations 1
Slide 3: Rheos vs. Barostim neo
Rheos vs. Barostim neo 2
Slide 4: XR-1 Verification Trial in Hypertension
XR-1 Verification Trial in Hypertension • 30 subjects at 6 sites in Europe and Canada • Systolic BP ≥ 140 mmHg • ≥3 anti-hypertensive meds, at least one a diuretic • Optimal stable anti-hypertensive therapy for at least 4 weeks • Device implanted after all enrollment criteria met • All devices turne
Slide 5: Primary Objectives
Primary Objectives • Primary Efficacy Objective – To describe the reductions in office cuff systolic blood pressure through 6 months of baroreflex activation therapy with the XR‐1 system • Primary Safety Objective – To describe the safety of baroreflex activation therapy utilizing the XR‐1 system by
Slide 6: Demographics
Demographics Characteristic N Mean ± SD or N(%) Age (years) 30 57 ± 12 Female 30 16 (53%) White / Caucasian 30 30 (100%) BMI (kg/m2) 30 30 ± 4 Systolic BP (mmHg) 30 172 ± 20 Diastolic BP (mmHg) 30 100 ± 14 Heart Rate (bpm) 30 75 ± 12 History of Diabetes 30 7 (23%) History of Chronic Kidney Disease 3
Slide 7: Medications
Medications Number of N Medication Patients ACE/ARB 30 28 93% Aldosterone antagonist 30 10 33% Beta-Blocker 30 26 87% Calcium Channel Blocker 30 22 73% Diuretic - K-sparing 30 3 10% Diuretics - Thiazides 30 22 73% Diuretics - loop 30 6 20% Sympatholytic 30 17 57% 6
Slide 8: Procedure Details
Procedure Details Mean ± SD Variable N or N (%) Procedure Time (hours) 30 1:47 ± 0:28 Mapping Time (hours) 30 0:44 ± 0:28 • Excluding first 2 implants at sites, implant time averaged 1:37 ± 0:29 • Rheos average implant time about 3 hours, with average mapping about 1.25 hours 7
Slide 9: Small Single-sided Incision
Small Single-sided Incision 8
Slide 10: Blood Pressure and Heart Rate Changes
Blood Pressure and Heart Rate Changes SBP DBP HR Baseline 172 ± 20 100 ± 14 75 ± 12 Change in BP or HR (mmHg or bpm) 0 -5 -10 ^ -15 Month 3 * * Month 6 -20 -25 -30 * * -35 * p<0.001; ^ p=0.06 9
Slide 11: Barostim neo vs. Rheos Efficacy
Barostim neo vs. Rheos Efficacy neo Rheos System System Unilateral Bilateral 0 -5 Change in Systolic BP (mmHg) -10 -15 3 Months BAT 6 Months BAT -20 -26 -26 -26 -25 -30 -35 Barostim neo Pivotal Immediate On Group (n=30) -40 (n=181 patients) 10 Source: CVRx Data File
Slide 12: System or Procedure-related Complications
System or Procedure-related Complications Days Patients from Procedure System Free from Event Implant Related Related Status Events (%) Peri-operative events 90% Device pocket hematoma 3 Yes No Recovered, no residual effects Self-inflicted wound 7 Yes No Recovered, no residual effects complication I
Slide 13: Safety Comparison to Rheos First Patients
Safety Comparison to Rheos First 30 Patients 12
Slide 14: Baseline BP, HR by history of renal nerve ablation
Baseline BP, HR by history (Hx) of renal nerve ablation (RNA) 200 Baseline BP or HR (mmHg or bpm) 180 160 Hx RNA (N=6) No Hx RNA (N=24) 140 120 100 * 80 60 SBP DBP HR 13
Slide 15: Response by history of renal nerve ablation
Response at 6 mo by history (Hx) of renal nerve ablation (RNA) 0 -5 Change in BP or HR (mmHg or bpm) -5 -13 -5 -10 -5 -15 Hx RNA (N=6) -11 -13 No Hx RNA (N=24) -20 -25 -22 -30 -27 -35 SBP DBP HR 14
Slide 16: Summary
Summary Barostim neo system Maintains the anti-hypertensive efficacy of its predecessor 26 mm Hg reduction in systolic BP at 6 months Simplifies implant procedure Greatly improves safety profile 90% patients free from 30d event 97% patients free from long-term events Provides viable treatmen