Cvrx, Inc. · NASDAQ:CVRX
Cvrx — Technical Presentation (October 2009)
13 slides from Cvrx's technical presentation, Oct 3, 2009
Slide 1: Baroreflex Activation Therapy Preserves eGFR in Hypertensive Patients with CKD
Baroreflex Activation Therapy Preserves eGFR in Hypertensive Patients with Stage 2 and 3 Chronic Kidney Disease: Results from European and United States Trials of the Rheos® System 1 Domenic Sica, 2 Marcos Rothstein, 3 John D. Bisognano, 4 Mitra K. Nadim, 5 Eric G. Lovett, 5 Christopher Kaufman, 6 P
Slide 2: Majority of US Hypertensive Patients Not at Systolic BP Goal of <140 mmHg
Majority of US Hypertensive Patients Not at Systolic BP Goal of < 140 mmHg Hypertensive N = 73.6 million Aware (79%) Unaware (21%) 57.9 million 15.7 million Treated (69%) Untreated (10%) 50.8 million 7.1 million 40.2 million (55%) not at goal Controlled (45%) Uncontrolled (24%) 33.4 million 17.4 mil
Slide 3: The CVRx Rheos System
The CVRx® Rheos System Programming System Baroreflex Activation Lead Implantable Pulse Generator
Slide 4: Blood Pressure Reduction with Baroreflex Activation Therapy
Blood Pressure Reduction with Baroreflex Activation Therapy Systolic Diastolic (Baseline = 192 mmHg) (Baseline= 108 mmHg) 0 Antihypertensive Change in Blood Pressure -5 Medications Baseline 5.1 ± 1.2 -10 12 months 4.5 ± 1.1 (mmHg) -15 -18 24 months 4.4 ± 2.0 -20 -21 -21 36 months 4.4 ± 1.5 -25 -30 1
Slide 5: Feasibility Trial Design
Feasibility Trial Design • Subjects implanted at both European and US centers – Multi-drug resistant systolic hypertension (SBP > 160 mmHg) – 3 or more antihypertensive medications with one being a diuretic – No treatable secondary cause of hypertension – Antihypertensive medications constant during
Slide 6: Methods
Methods • Serum creatinine was determined at a central core lab using standard methodology • eGFR was determined from serum creatinine data with the MDRD equation. • eGFR determinations were made on a sample of patients who had complete data available at 12 months and were identified as Stage 2 or 3
Slide 7: Baseline Characteristics
Baseline Characteristics Stage 2 Stage 3 (N = 11) (N = 13) Gender 2 female, 9 male 8 female, 5 male Race 11 Caucasian 11 Caucasian, 1 African American, 1 Native American Age (years) 56 ± 10 61 ± 9 # Antihypertensive Meds 5.0 ± 1.5 4.3 ± 1.2 Antihypertensive Therapeutic Index 34.7 ± 19.3 36.3 ± 8.9 S
Slide 8: Baseline Medications
Baseline Medications Stage 2 Stage 3 Medication Class (%) (%) ACE Inhibitor/Angiotensin Receptor Blocker 100 84.6 Alpha Blocker 27.3 46.2 Beta Blocker 81.8 69.2 Calcium Channel Blocker – dihydropyridines 81.8 61.5 Calcium Channel Blocker – non-dihydropyridines 0 15.4 Diuretic 100 100 Thiazide 90.9 6
Slide 9: eGFR Over Time with BAT in Stage 2 and 3 CKD
eGFR Over Time with Baroreflex Activation Therapy in Stage 2 and 3 CKD 90 80 eGFR (mL/min/1.73m2) 70 78.3 74.9 60 50 54.2 57.4 40 30 20 10 0 Stage 2 Stage 3 Pre-Implant 12 Month *Changes in eGFR after 1 year were not related to pre-implant eGFR
Slide 10: GFR in Treated and Untreated Hypertensives
GFR in Treated and Untreated Hypertensives 122 125 Potential Reduction For BAT Cohort If Left Untreated From: Bakris et al. Am J Kidney Dis 2000;36(3)646-61.
Slide 11: Reduction of Left Ventricular Mass Index with BAT
Reduction of Left Ventricular Mass Index with Baroreflex Activation Therapy 180 160 140 120 140 LVMI (g/m2) 100 116 P < 0.001 80 60 40 20 0 Pre-Implant Month 12 Stage 2 & 3 Combined (N = 12)
Slide 12: Conclusions
Conclusions • Baroreflex Activation Therapy results in sustained and significant reduction in blood pressure in subjects with resistant hypertension already on maximal medical therapy • Preservation of eGFR in CKD patients on maximal medical therapy suggests that Rheos therapy may be renoprotective.
Slide 13: Acknowledgments
Acknowledgments • Inselspital Bern, Switzerland • University Hospital Bad Oeynhausen, Germany • Academisch Ziekenhuis Maastricht (AZM), The Netherlands • Charité Campus Buch, Berlin, Germany • Medizinische Hochschule Hannover, Germany • Virginia Commonwealth University, Richmond VA • University of R