Cvrx, Inc. · NASDAQ:CVRX
Cvrx — Technical Presentation (May 2013)
9 slides from Cvrx's technical presentation, May 2013
Slide 1: Barostim Therapy: Pivotal Trial Results of Long Term Follow-up
Barostim Therapy Pivotal Trial Results of Long Term Follow-up Prof. George Bakris The University of Chicago Medicine Director, ASH Comprehensive Hypertension Center Chicago, IL CAUTION: The Rheos® System is an investigational device and is limited by Federal (or United States) law to investigational
Slide 2: Presenter Disclosure Information
Presenter Disclosure Information Dr. George Bakris DISCLOSURE INFORMATION: The following relationships exist related to this presentation: CVRx Honorarium for presentations
Slide 3: Long-Term Follow-up Protocol Rationale
LongTerm Follow-up Protocol Rationale After the 12 month period, FDA instituted a process for approval of routine battery replacement through individual compassionate use applications. This approach rapidly became untenable as the agency was inundated with petitions detailing physician opinion t
Slide 4: FDA Clinical Responder Criteria
FDA Clinical Responder Criteria SBP reduction sustained during last 2 of 3 visits: Achievement of goal SBP (≤ 140 mm Hg or ≤ 130 mm Hg in diabetes/renal disease) OR SBP reduction ≥ 20 mm Hg from activation SBP rise following device deactivation: SBP increase ≥ 20 mm Hg at last 2 of 3 visit
Slide 5: Patient Status
Patient Status 322 November Implanted 2009 10 (3%) Clinically significant responders* 46 (14%) Terminated 36 (11%) Indeterminate or non-responding 276 (86%) 2010 Consented Rev-E May 244 (76%) 32 (10%) Clinically significant Indeterminate responders* September 186 (58%) 45 (14%) 13 (4%) 2011 BP Respo
Slide 6: Changes in BP
Changes in BP 183 No BAT 178 180 BAT 168 169 169 170 SBP using BpTRU (mmHg) 160 160 152 Group A Group B Group B Roll-in 150 146 145 143 143 142 Goal – 140 N=322 N=322 N=84 181 54 N=80 170 52 N=78 166 50 N=271 Pre‐Activation Most Recent Screening Pre‐Implant (1 month post‐ Month 6 Month 12 (22 – 53 m
Slide 7: Baseline and Follow-up Characteristics
Baseline and Follow-up Characteristics Responder Pre- Implant Month 12 Last Visit (N=244) (N=233) (N=239) Mean (SD) Mean (SD) Mean (SD) Systolic BP (mmHg) 177 (22) 139 (27) 142 (29) Diastolic BP (mmHg) 102 (15) 85 (16) 86 (18) Heart Rate (mmHg) 73 (15) 71 (14) 72 (14) Number of BP Meds 5.3 (1.9) 4.7
Slide 8: Programming
Programming During long-term follow-up, the full range of programmed parameters and device modes was permitted to maintain and improve BP responses. At the most recent visit, 40% of responders were programmed to device settings that were not allowed during the first 12 months, and 28% were progr
Slide 9: Summary
Summary Long term effects of the Rheos device appear to provide sustained reduction in blood pressure among individuals who received an initial benefit. Further trials are ongoing in Europe and hopefully soon in the US to assess whether the newer version of the device Neo will prove to be as eff