1. VCU Pauley Heart Center:
A 2010 US News Top 50 Heart and Heart Surgery Hospital

2. PCI in Evolution: A Novel Approach Utilizing a Robotic Interventional System
George W. Vetrovec, MD.
Kimmerling Professor of Cardiology
VCU Pauley Heart Center
Virginia Commonwealth University
Richmond, Virginia

3. Disclosures Grants: Cordis, Merck, Corindus.
Consultant: Merck, Pfizer, Lilly, Roche.
Speakers Bureau: Cordis, Lilly-Diiachi Sankyo, Gilead.
I am an Interventional Cardiologist

4. Occupational hazards in the cath lab: Staff
Risks associated with high exposure to harmful x-ray radiation
Cancer and cataracts
High instance of spinal problems created from wearing lead aprons
50% of all ICs report chronic back pain vs. 27% of all adults1
15 pound lead apron can place pressures of up to 300 pounds per square inch of intravertebral discs2
Eye and neck repetitive strain injuries due to poor ergonomics of the cath lab

5. PCI Challenges Today: Patients
Challenges that impede success
Limited precision and control
Procedures not consistent or standardized
Large inter-operator variability
STLLR trial reports 47.6% Longitudinal Geographical Miss
10-20% of patients require a second stent due to inaccurate placement or size of first stent1
Wire and device slippage
High doses of contrast media
Geographical Miss
Uncovered plaque
Stent sizing
Device placement

6. CorPath™ System Operator Console Single-use Cassette Robotic Drive
Interventional Cockpit
Robotic Drive
Single-use Cassette
Operator Console
Operator Console
Single-use Cassette
Robotic Drive
Interventional Cockpit

7. CorPath Interventional Cockpit

8. CorPath Robotic Drive
Articulated Arm
Robotic Drive

9. CorPath System Controls
Fixate
Advance
Retract
Rotate
Measure

10. Precise Measurements Unrelated to angiographic view
Not affected by foreshortening
The measurement feature is potentially useful for determining lesion length for stent selection or understanding the distance between 2 branch arteries.

11. Guidewire Fixation No accidental wire movement
Wire locked during stent delivery
Better support for bifurcations and complex lesions

12. Precise Stent Deployment
Optimal lesion coverage
Avoid occluding side branches
Exact stent placement for ostial lesions
Accurate placement of overlapping stents
Stent deployment from the cockpit

13. Complex Bifurcation Interventions

14. Preliminary Experience: Easy to Use
Easy installation – No construction
Short physician learning curve
Familiar procedure sequence
Simple user interface
Save time
Simple to load cassette
Efficient navigation
Fast accurate measurement
Open architecture
You can select your wires and devices

15. Three-Vessel PCI in Swine: Robotic-Assisted with CorPath 200 System vs
Three-Vessel PCI in Swine: Robotic-Assisted with CorPath 200 System vs. Manual Intervention 19

16. Confidential Corindus Inc.
Objective
The study was designed to assess and demonstrate safety and technical efficacy of the CorPath® 200 vascular robotics system in delivery and manipulation of coronary guidewires and stent and balloon systems for PCI and compare it with the standard manual delivery of the same devices in acute and 30-day chronic porcine model.
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17. Confidential Corindus Inc.
Methods
Twelve animals underwent 3-vessel (RCA, LCX and LAD) manual or CorPath-assisted PCI. The procedure involved every vessel balloon pre-dilated followed by two vessels stenting with either bare metal or drug eluting stents.
The procedural characteristics – Procedure Time, X-Ray Time, Contrast Volume and Radiation exposure to the animal and the operator - were monitored in addition to clinical and histopathologic analysis of intervented vessels.
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18. Confidential Corindus Inc.
Results
All study devices were successfully deployed and all animals survived to their respective study endpoints. There were no early deaths. QCA demonstrated that angiographic results of deployment of stents or balloon catheters in porcine coronary arteries with the CorPath 200 System were not different from Manual deployment.
Procedure
Procedure Time (min)
X-Ray Time (min)
Contrast Volume (mL)
Radiation Exposure
Cumulative Dose(mGy)
Operator (µGy)
Manual
33.81 ±12.43
11.87± 4.97
154.2± 48.5
859.5 ±449.5
14.14 ±8.89
CorPath 200
± 4.57
9.9 ± 2.27
108.3 ±34.2
792.7 ±339.9
4.30 ±7.23
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19. Confidential Corindus Inc.
Conclusions
Robotic-assisted PCI was successful and comparable to the manual procedure in many categories: procedure time, X-Ray time and cumulative radiation exposure to the animal. There was significantly less radiation exposure to the operator as well as lower contrast volume in robotic-assisted PCI as compared to the manual procedure. Myocardial histopathology was not different between two procedures.
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20. Confidential Corindus Inc.
CORBIC FIRST-IN-MAN
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21. First-in-man Corbic Study
March-April, 2010
Location CORBIC Instituto Cardio-Neuro-Vascular Medellin, Colombia
Investigators: Dr. Giora Weisz
Dr. Juan Granada
Study Objective To evaluate the safety and technical efficacy of the use of the CorPath system in delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI)
Protocol: De novo lesion mm in diameter and ≤25 mm in length with >50% stenosis
Primary Endpoint Achievement of a < 30% final diameter stenosis after utilizing the CorPath system to deliver a balloon/stent to target lesion, and successfully retracting the device without the occurrence of any In-Hospital MACE
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22. FIM Corbic Overview Patients - 8
Clinical and Technical Considerations
Symptomatic, positive stress test
Significant CAD
Wire, balloon and stent manipulated by the CorPath system
Radiation Measurement
6 Fr Guide
0.014” Guide wire
Pre-dilatation balloon mm
Stent mm X mm

23. FIM Patient Characteristics Patients - 8
Factor N %
Mean +/-SD
Age
67.8+/-10.7
Male 3
37.5
Hyperlipidemia 6 75
Diabetes
Smoking (Prior)
Hypertension
Prior MI 2 25
Unstable Angina 7
87.5

24. FIM Trial Baseline ANATOMY 8 Lesions N % RCA 3 37.6 LCx LAD 1 12.5 PDA
Target Lesion
N %
RCA
LCx
LAD
PDA
LVEF (%)
59.4+/-8.6
LESIONS 1
Length (mm)
11.4+/-6.1
RVD (mm)
3.0+/-7.4
MLD (mm)
2.4+/-3.1
Diam Sten
63.1+/-15%
Thrombus
0 (0%)
TIMI III
8 (100%)
1 % stenosis, lesion and vessel dimensions per QCA evaluation

25. CorPath Procedure Time (minutes) Total Fluoroscopy Time (minutes)
FIM Procedure Results
CorPath Procedure Time (minutes)
N (%)
Mean  SD (N)
25.3 7.2 (8)
Median (Range)
25 (12-35)
Total Fluoroscopy Time (minutes)
11.53 3.7 (8)
12.0 ( )

26. % Diameter stenosis-post-procedure
FIM Procedure Results
% Diameter stenosis-post-procedure
Mean - 0.0% +/-0.0
+/-SD
TIMI III Flow – 100%
Free from MACE
Discharge – 100%
30 Days %
CKmb Rise post 8, 12, 24 Hrs. – 0%
One late adverse event unrelated to procedure

27. FIM Results – Radiation (µGy)
Table Operator
CorPath Operator
97.3
3.78
41.59
50.5
12.65
3.5
26.91
33.33
3.68
183.
47.3
Mean ± 54.95
1.81 ± 1.93
97.1%
Confidential Corindus Inc.

28. Radiation Exposure No additional exposure to the patient
Corindus BOD meeting
Radiation Exposure No additional exposure to the patient
Control Data
Corbic FIM Data
Corindus data
50 %
Age (y)
67.8 64
Height (cm)
160.2
169
Weight (Kg)
70.1 76
Flouro time (min)
12.3
11.7
Patient Radiation (Gy)
1.73
1.9
Physician radiation (Gy)
N/A
Contrast (ml)
158.7
250
Comparable radiation to the patient
Comparable flouro time
Significantly reduced physician radiation
Significantly reduced contrast dose 36
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29. CORBIC Study vs. Historic Data
Corindus BOD meeting
CORBIC Study vs. Historic Data
Lesions Treated (#)
Stents (#)
Fluoroscopy Time (min)
Procedure
Time (min)
Nikolsky et al, 2007
All patients
Fluoro time >23 min (2,408)
Fluoro time ≤23 min (7,242)
1.87 ± 0.99
1.35 ± 0.65
1.88 ± 1.36
1.20 ± 0.83
18.3 ± 12.2
37.1 ± 29.3
12.7 ± 5.1
81.6 ± 60.6
119.6 ± 70.4
71.7 ± 53.5
CORBIC Study
1.0
11.5 ± 3.7
43.0 ± 18.61
1 CorPath Procedure time was 25.3±7.2 min
The mean fluoro time from Corbic study compared favorably with the results of the reference study
Even the longest fluoro time from Corbic study (15.5 min) fallen in the 50th percentile of fluoroscopy time in the referenced study (15.1 min)
The mean procedure time in this study was significantly shorter than procedure time in the referenced study
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December 19, 2007 37

30. CORPATH® PRECISE STUDY
Confidential Corindus Inc. 38

31. PRECISE Study Overall Objective:
To evaluate safety and effectiveness of CorPath 200 System in delivery and manipulation of coronary guidewires and stent/balloon catheters during CorPath-assisted PCI
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32. Clinical Sites & Operators
Investigators
NY-Presbyterian Hospital/Columbia University Medical Center
New York, NY
Giora Weisz, MD
Jeffrey W. Moses, MD
St. Elizabeth’s Medical Center Boston, MA
Joseph P. Carrozza Jr, MD
Lawrence A. Garcia, MD
VCU Pauley Heart Center Richmond, VA
George W. Vetrovec, MD
Evelyne Goudreau, MD
St. Joseph Hospital
Syracuse, NY
Ronald P. Caputo, MD
Michael Fischi, MD
Swedish Heart & Vascular Institute
Seattle, WA
Mark Reisman, MD
Paul Huang, MD
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33. PRECISE Study Study Design Sample Size Study Population:
This trial is a prospective, single-arm, multi-center, non-randomized study of the CorPath 200 System. Clinical data collected during the study will be compared to the Performance Goal derived from a meta-analysis of the studies using traditional stenting therapy
Sample Size
Up to 154 subjects shall be treated in the study at up to 8 clinical sites
Study Population:
Subjects with symptomatic, ischemic heart disease requiring PCI stenting for a single de novo native coronary artery lesion with reference vessel diameter 2.5–4.0 mm and lesion length <24.0 mm.
Study Duration: 
The anticipated enrollment period is 5 months/site with a 30-day follow-up period. The study completion is expected in 6-8 months
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34. Co-Primary Endpoints PRECISE Study
Clinical Procedural Success defined as <30% residual stenosis in target lesion at the completion of the procedure, in the absence of MACE at 48-hrs post index procedure or at hospital discharge, whichever occurs first
Device Procedural/Technical Success defined as successful advancement and retraction of the PCI devices using CorPath 200 (i.e. without conversion to manual operation).

35. Potential Procedural Advantages
Precision
Discrete, controlled linear movement and rotation
Accurate length measurements
Precise device placement
Stability
No unintended movements
Y-connector is held in place
Catheter and wire locked during device deployment
Control
Potential reduced fluoro and contrast
Better visualization of angiography and vitals

36. Potential Patient Advantages
Procedure improvements translate to patient benefits
More accurate device selection & placement
Better visualization
Shorter procedure duration
Less contrast media
Reduced radiation exposure