1. Prof. Joachim Schofer, MD
Clinical evidence in catheter-based renal sympathetic denervation - building the data
Prof. Joachim Schofer, MD

2. Potential conflicts of interest
Speaker's name: Joachim Schofer
 I have the following potential conflicts of interest to report:
Consultant: … State the different companies concerned
Employment in industry: …
Honorarium: …
Institutional grant/research support: …
Owner of a healthcare company: …
Stockholder of a healthcare company: …

3. Boston Scientific Vessix™ Renal Denervation System
Balloon-based technology (sizes 4 – 7 mm)
Low pressure non-compliant balloon (3 atm/304 kPa)
Helical pattern of RF electrodes for uniform treatment
30 second treatment time with up to 8 RF electrodes activated simultaneously
Electrodes that are unapposed to vessel wall are automatically deactivated
Bipolar energy delivery, using energy of ~1W
Temperature control algorithm ensures energy deliver at precisely 68°C
One button operation
CE marked and TGA approved

4. Boston Scientific Vessix™ Renal Denervation Clinical Program
REDUCE-HTN FIM
(First Cohort N=18)
Objectives and Results
Multicenter feasibility study to assess performance of Vessix™ system Patients with resistant hypertension
≥ 160mm Hg SBP
≥ 3 antihypertensive medications at maximum tolerated doses
18 subjects enrolled at 6 clinical sites in EU and AU
Primary acute safety endpoint met
No Renal artery dissection or perforation during the procedure that requires stenting or surgery
No Renal artery infarction or embolus
No Cerebrovascular Accident (CVA) at time of procedure
No Myocardial infarction at time of procedure
No Sudden cardiac death at time of procedure
REDUCE-HTN Post Market Study
(Expanded Cohort N=146)
Clinical Study Overview
Postmarket surveillance clinical study for medication resistant hypertension
Single cohort, international, multi-center, prospective, non-randomized
128 subjects enrolled at 23 clinical sites in EU, AU, and NZ
Continued follow up on FIM 18 subjects
≥ 160 mmHg SBP
Patients with accessory renal arteries were enrolled and treated
Renal artery length ≥ 15 mm

5. REDUCE-HTN Final Enrollment Data Enrollment Complete April 2013
Total Enrollment N=146
Top Enrolling Sites:
Patients Center
23 Prof. Joachim Schofer
Universitäres Herz- und Gefäßzentrum
Hamburg Germany
14 Prof. John Ormiston
Mercy Angiography - Auckland New Zealand
Prof. Uta C. Hoppe
Parcelsus Medical University Austria
12 Prof. Ian Merideth
Monash Heart Southern Health Australia
11 Prof. Darren Walters
The Prince Charles Hospital Australia
European
Sites
Sites

6. Boston Scientific Vessix™ Renal Denervation Clinical Program
REDU CE- HTN
First in Man
Post Market Study
FIM Enroll ment
N=18
PMS Enroll ment
N=128
6M Follow- Up % (18/18)
12M Follow- Up - 56% (10/18)
6M Follow- Up - 18% (23/128)
12M Follow- Up - 0% (0/128)
REDUCE-HTN FIM+PMS
Intent to Treat (ITT)
6M Follow-Up - 28% (N=41)
12M Follow-Up - 7% (N=10)
* 100% patient follow-up continues no attrition as of May 2, 2013

7. REDUCE-HTN Study Endpoints
Efficacy Endpoint – Reduction of SBP and DBP (Office Based and ABPB) at six months post procedure compared to baseline
Safety Endpoint
Acute Safety
Renal artery dissection or perforation during the procedure that requires stenting or surgery
Renal artery infarction or embolus
Cerebrovascular Accident (CVA) at time of procedure
Myocardial infarction at time of procedure
Sudden cardiac death at time of procedure
Long-term Safety
Renal stenosis requiring an intervention documented by angiography
Absence of flow limiting stenosis in the renal artery at six (6) months measured by duplex ultrasound
SBP=Systolic Blood Pressure; DBP=Diastolic Blood Pressure; ABPB=Ambulatory Based Blood Pressure.

8. Baseline Subject Characteristics
REDUCE-HTN
Baseline Subject Characteristics
Subject based – Intent To Treat Population
Vessix™(FIM +PMS)
N=41
Demographics
Age (years)
59.2 ± 11.0
Gender (female)
39.0%
Ethic Origin (white)
92.7%
Co-Morbidities
Type 2 Diabetes
31.7%
Coronary Artery Disease
46.3%
Dyslipidemia
68.3%
Blood Pressure
Baseline Systolic Blood Pressure (mmHg)
183.2 ± 18.1
Baseline Diastolic Blood Pressure (mmHg)
98.6 ± 17.1
Kidney Function
eGFR (mL/min/1.73 m2)
80.7 ± 27.0
Serum Creatinine (μmol/L)
81.5 ± 23.6
eGFR=Estimated Glomerular Filtration Rate
Data as of 2-May-2013 8

9. Baseline Antihypertensive Medications
REDUCE-HTN
Baseline Antihypertensive Medications
Subject based – Intent To Treat
Vessix™ (FIM +PMS)
N=41
Number of Antihypertensive Medications per Subject
5.1 ± 1.7
Subjects on ≥ 5 Medications
53.7%
Subjects on 4 Medications
31.7%
Subjects on 3 Medications
9.8%
Subjects Receiving
ACE Inhibitors or ARBs
92.7%
Direct Renin Inhibitors
19.5%
β Blockers
73.2%
α-1 Blockers
43.9%
Calcium Channel Blockers
70.7%
Diuretics
75.6%
Nitrate and Other Vasodilators
7.3%
Centrally Acting Sympatholytic
Aldosterone Antagonist
26.8%
Other Anti-hypertensive
4.9%
ACE=angiotensin-converting enzyme; ARB=angiotensin-receptor blocker
Data as of 2-May-2013 9

10. Intent To Treat Population
REDUCE-HTN
Vessix™ Procedure
Number of Events*
Intent To Treat Population
(N=41)
*DSMB - Adjudicated
** Flank Pain resolved in < 48 hours - categorized as SAE due to extended hospital stay for observation - additional testing was negative
Data as of 2-May-2013

11. Vessix™ System Renal Denervation
Pre Treatment
Distal
Proximal
Put in cines or taped case clips (no audio) of pre aortogram, vessix positioning, inflation, and treatment.
Limited time, keep under 1.5 minutes
Vessix™ balloon treatments with electrodes visible
Images of Case REDUCE-HTN. Results from case studies are not predictive of results in other cases. Results in other cases may vary.

12. % Successful Treatments*
Vessix™ System Renal Denervation Absence of Spasm and Continued Patency
% Successful Treatments*
N=41
Pre Treatment
Post Treatment
*Successful Treatment Analysis - Intent To Treat Population
Images of Case REDUCE-HTN. Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Data as of 2-May-2013

13. REDUCE-HTN - Chronic Safety
Renal Artery Patency – Intent To Treat
All treated renal arteries with 6 month post treatment diagnostic DUS were patent (adjudicated by core lab analysis, VasCore; Boston, MA)
One patient had progression of existing stenosis at 6 months* which required no additional treatment (Protocol Deviation -Baseline renal artery stenosis was > 30% by angiographic core lab assessment)
6M follow-up OBP -33/-15 mmHg
Patient continues to be followed
Baseline
6 Month Follow-up
R – 39% DS mild calcification
L – 25% DS mild calcification
R – 55% DS (Out of treatment zone)
L – 69% DS (Out of treatment zone)
*DUS non evaluable, detected by angiography.
Images of Case REDUCE-HTN. Results from case studies are not predictive of results in other cases. Results in other cases may vary.
OBP=Office Based Blood Pressure; DS=Diameter Stenosis; DUS=Duplex Ultrasound. Data as of 2-May-2013

14. REDUCE-HTN - Chronic Safety
Stable Renal Function - Intent To Treat
Baseline 6M
Change
Overall (N=40)
80.7 ± 27.0
79.3 ± 25.2
-1.5 ± 16.3
FIM (N=18)
69.0 ± 15.0
70.5 ± 22.5
1.6 ± 11.8
PMS (N=22)
90.2 ± 31.0
86.2 ± 25.5
-4.0 ± 19.1
eGFR (mL/min/1.73 m2)
Renal Function Analysis: Intent To Treat Population
Data as of 2-May-2013

15. Significant Office Blood Pressure Reduction
REDUCE-HTN
Significant Office Blood Pressure Reduction
1 Month
N=41
Systolic Diastolic
3 Month
N=41
Systolic Diastolic
6 Month
N=41
Systolic Diastolic
12 Month
N=10
Systolic Diastolic
BP change (mm Hg)
p <0.05 for all time points
Efficacy Data Analysis: Intent To Treat Population
Data as of 2-May-2013

16. Conclusion
Results continue to show that the Vessix™ System is a safe and effective method for the treatment of uncontrolled hypertension
Successful bilateral renal denervation treatment in 100% of patients
Significant office blood pressure reduction at all pre-specified time points
No device related adverse events
No acute procedural renal artery complications, cerebrovascular (CVA), MI, or sudden cardiac death
Low occurrence of procedural adverse events