1 Chronic Treatment of Resistant Hypertension with an Implantable Medical Device: Interim 3 Year Results of Two Studies of the Rheos ® Hypertension System.

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Presentation transcript:

1 Chronic Treatment of Resistant Hypertension with an Implantable Medical Device: Interim 3 Year Results of Two Studies of the Rheos ® Hypertension System Marcos Rothstein 1, Peter de Leeuw 2, Myriah Elletson 3 for the DEBuT and Rheos Feasibility Investigators 1 Washington University School of Medicine 2 Academisch Ziekenhuis Maastricht (AZM) 3 CVRx, Inc.

Confidential & Proprietary Information of CVRx Inc. 2 Outline Background and rationale for the Rheos Hypertension System Study design and methods Interim clinical data on a device-based approach for treatment of drug resistant hypertension Conclusion and next steps for the assessment of chronic baroreflex activation as a potential new approach for the management of resistant hypertension and other conditions

Confidential & Proprietary Information of CVRx Inc. 3 Majority of US Hypertensive Patients Not at Systolic BP Goal of < 140 mmHg 3 Hypertensive N = 73.6 million Hypertensive N = 73.6 million Aware (79%) 57.9 million Aware (79%) 57.9 million Unaware (21%) 15.7 million Unaware (21%) 15.7 million Untreated (10%) 7.1 million Untreated (10%) 7.1 million Treated (69%) 50.8 million Treated (69%) 50.8 million Controlled (45%) 33.4 million Controlled (45%) 33.4 million Uncontrolled (24%) 17.4 million Uncontrolled (24%) 17.4 million 40.2 million (55%) not at goal D Lloyd-Jones et al., Circulation, Heart Disease and Stroke Statistics – 2009 Update: 6:e87-e95 Based on Data from NHANES/NCHS

Confidential & Proprietary Information of CVRx Inc. 4 The CVRx ® Rheos System Implantable Pulse Generator Implantable Pulse Generator Baroreflex Activation Leads Baroreflex Activation Leads Programming System Programming System

Confidential & Proprietary Information of CVRx Inc. 5 Comprehensive Mechanism of Action

Confidential & Proprietary Information of CVRx Inc. 6 Ability to Personalize and Control the Therapy

Confidential & Proprietary Information of CVRx Inc. 7 Feasibility Trial Design Subjects implanted at both European and US centers – Multi-drug resistant systolic hypertension (SBP > 160 mmHg) – 3+ anti-hypertensive medications with 1 diuretic – Must not have hypertension secondary to a treatable cause – Anti-hypertensive medications constant during the first 3 months of active treatment per protocol design – Continued annual follow-up BaselineImplant Months

Confidential & Proprietary Information of CVRx Inc. 8 Baseline Characteristics (N=38) Location25 Europe, 13 US Gender17 female, 21 male Race32 Caucasian, 5 African American Age (mean years ± sd)53 ± 11 # Antihypertensive Meds (mean ± sd)5.1 ± 2 Antihypertensive Therapeutic Index35.8 ± 17 OC Systolic BP (mean mmHg ± sd)183 ± 27 OC Diastolic BP (mean mmHg ± sd)105 ± 21 OC Heart Rate (mean bpm ± sd)78 ± 12 OC = Office Cuff

Confidential & Proprietary Information of CVRx Inc. 9 Baseline Medications Medication Class% Diuretic100 % ACE Inhibitor/A2 Receptor89 Beta Blocker81 Calcium Channel Blocker - dihydropyridines68 Other Sympatholytic40 Alpha Blocker39 Minoxidil23 Calcium Channel Blocker – other16

Confidential & Proprietary Information of CVRx Inc. 10 Office BP Response to Rheos Therapy Systolic (Baseline = 183 mmHg) Diastolic (Baseline = 105 mmHg) Heart Rate (Baseline = 78 BPM) *p value < † p value = < † † p value = 0.15 Mean change in mmHg or BPM -25* -22* -31* -15* -21* -7 † -8 † -5 † †

Confidential & Proprietary Information of CVRx Inc. 11 Percentage of Subjects at Different Stages of Hypertension by Visit SBP ≥ 160 SBP SBP < 140

Confidential & Proprietary Information of CVRx Inc. 12 Change in Antihypertensive Therapeutic Index over Time 1 Year Mean change in ATI -5* -11** 2 Years3 Years *p value = 0.05 **p value < 0.001

Confidential & Proprietary Information of CVRx Inc. 13 Diurnal Variation Preserved (24-hour Ambulatory, N=19)

Confidential & Proprietary Information of CVRx Inc. 14 Cardiac Structure and Function Improvements N=18BaselineΔ 12 Months LV Mass Index (g/m 2 )132.8± 33.3–25.0± 18.2* Left Atrial Dimension (mm)44.1± 8.1–2.4± 3.5* Mitral E Wave Velocity (cm/s)85± 19–5± 14 Mitral A Wave Velocity (cm/s)83± 22–10± 13* Bisognano JD. Journal of Cardiac Failure 2008;14(No. 6S Suppl):S48. Severely Abnormal Mildly or Moderately Abnormal Reference Range Values: mean ± SD *p value <0.05

Confidential & Proprietary Information of CVRx Inc. 15 Case Example LVMi and BP Reduction Following 3 Months of Rheos Therapy Septal Wall Thickness = 1.16 cm LV End-Diastolic Diameter = 5.16 cm BP = 185/95 mmHg ATI = 22.5 ; BMI = 34.4 kg/m 2 Septal Wall Thickness = 0.90 cm LV End-Diastolic Diameter = 4.12 cm (SBP ↓ 30 mmHg, DBP ↓ 14 mmHg) ATI = 22.5 ; BMI = 33.9 kg/m 2 LVMI = g/m 2 LVMI = 97.0 g/m 2 Pre-Implant 3-Months of Therapy

Confidential & Proprietary Information of CVRx Inc. 16 Case Example Improved LV Function After 3 Months of Rheos Therapy Pre-Implant 3-Months of Therapy

Confidential & Proprietary Information of CVRx Inc. 17 Group B - Device OFFGroup B - Device ON Group A - Device ON RandomizationImplant FDA Approved Phase III Pivotal Clinical Trial Long-Term Follow Up 6-Month Evaluation Period 2:1 (Group A: Group B) 6-Month Blinded Evaluation Period 0612 Prospective, randomized, double-blind, placebo-controlled, multi-center clinical trial Up to 300 patients, 50 medical centers Inclusion criteria: SBP ≥ 160 mmHg; 3+ medications Endpoint: % patients dropping > 10 mmHg with sustained reduction Months

Confidential & Proprietary Information of CVRx Inc. 18 Conclusions Baroreflex hypertension therapy demonstrates clinically meaningful and sustained reduction in blood pressure in subjects with drug resistant hypertension The Rheos therapy also has been shown to improve cardiac structure and function – please visit poster at 9.30a on Tuesday 31 March These findings merit further investigation of this chronic device-based approach for hypertension management A randomized, blinded pivotal trial approved by FDA is underway

Confidential & Proprietary Information of CVRx Inc. 19 Acknowledgments Inselspital Bern, Switzerland University Hospital Bad Oeynhausen, Germany Academisch Ziekenhuis Maastricht (AZM), The Netherlands Charité Campus Buch, Berlin, Germany Medizinische Hochschule Hannover Virginia Commonwealth University, Richmond VA University of Rochester, New York NY Washington University, St. Louis MO VA Medical Center, Washington DC Wayne State University Nebraska Heart Institute CAUTION: CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only. CVRx, Rheos, Baroreflex Hypertension Therapy are trademarks of CVRx, Inc. © CVRx, Inc