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.
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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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Chronic Treatment of Resistant Hypertension with an Implantable Medical Device: Interim 3 Year Results of Two
Studies of the Rheos® Hypertension System
Marcos Rothstein1, Peter de Leeuw2, Myriah Elletson3
for the DEBuT and Rheos Feasibility Investigators
1 Washington University School of Medicine
2Academisch 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
HypertensiveN = 73.6 million
Aware (79%)57.9 million
Unaware (21%)15.7 million
Untreated (10%)7.1 million
Treated (69%)50.8 million
Controlled (45%)33.4 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-e95Based on Data from NHANES/NCHS 2005-2006
Confidential & Proprietary Information of CVRx Inc.4
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 1051-168 at 9.30a on Tuesday 31 March 2009.
• 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 .