1. Novel atherectomy devices for the coronary calcified lesions
February 25, 2013
Robert Thatcher
Executive Vice President
Cardiovascular Systems Inc. (CSI)
EN-1289.A
EN-1211 1

2. Severely Calcified Coronary Lesions
Technically challenging1
Difficult to stent
Higher procedural complications
Unable to treat
Medical therapy, angina
CABG
Associated with a higher MACE rate2
Higher frequency of MI
Higher frequency of restenosis
Higher death rates
Hoffmann R, Mintz GS, Popma JJ, Satler LF, Kent KM, Pichard AD, Leon MB. Eur Heart J 1998;19:1224–1231.
Moses JW, Carlier S, Moussa I. Rev Cardiovasc Med 2004;5 (Suppl. 2):S16–S21.
CONFIDENTIAL

3. Impact of Calcification: Procedural Non Q-Wave MI
Increasing amounts of calcium deposits leads to higher incidence of non Q-wave MI during PCI
12.3%
9.8%
8.0%
n = 315
n = 186
n = 86
n = 75
CONFIDENTIAL
Mosseri, et al. Cardiovascular Revascularization Medicine :

4. Calcium Is Underestimated
Standard angiography suboptimally visualizes coronary calcification
Mintz et. al. concluded “IVUS analysis shows that target lesion calcification is ubiquitous in coronary artery disease.”
Coronary lesions calcification was seen in
38% via angiogram vs 73% via IVUS
Mintz G, et al. Circulation. 1995;91:
CONFIDENTIAL

5. 1-Year Ischemic Outcomes
1-Year Ischemic Outcomes. ACS Population from ACUITY & HORIZONs Studies: 6,855 Patients
STEMI: 3,268 pts
ACS-N STEMI: 3,587 pts
26.7%
HR [95% CI]
1.64 [1.26,2.13]
1.70 [1.23,2.36]
1.12 [0.93,1.35]
1.55 [0.91,2.64]
1.35 [1.11,1.64]
1.25 [1.09,1.43]
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p = 0.001
p = 0.22
p = 0.002
p =
p = 0.001
p = 0.007
CONFIDENTIAL
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Genereux P. TCT2012 5

6. Calcification in ACS Population
n total = 6,855 pts
5.8%
26.1%
CONFIDENTIAL
c/o Genereux P.

7. 1-Year Ischemic Outcomes: ACS Population: 6,855 patients
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To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide.
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p = 0.002
p =
p =
p = 0.013
CONFIDENTIAL
EN-1211
c/o Genereux P. 7 7

8. ROTAXUS
240 pts with calcified lesions enrolled between August 2006 and March 2010 at 3 clinical sites in Germany
Mean age 71
DM 28%
MVD 74%
Ostial 18%
Bifurc 48%
B2/C 90%
1:1 randomization
IVUS not used
Rotablator + PES
(N=120)
PTCA + PES
(N=120)
2 patients died in-hospital
6 patients withdrew consent
5 patients lost at follow-up
9 months:
Clinical follow-up in 96.2% (N=227)
Angio follow-up in 80.5% (N=190)
*Primary endpoint: In-stent late loss
CONFIDENTIAL
Richart G., Late Breaking Trial Presentation at TCT 2011

9. ROTAXUS 9 Months Results
CONFIDENTIAL
Richart G., Late Breaking Trial Presentation at TCT 2011
Abdel-Wahab M. et al, JACC Cardiovasc Interv, 2012

10. Orbital Atherectomy System (OAS)
Electric OAS Features
Reduced set-up time
Operator control shifted to physician in sterile field
6F guide catheter compatible
Pneumatic OAS
Electric OAS
CONFIDENTIAL
Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.

11. OAS Mechanism of Action - Video
CONFIDENTIAL
Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.

12. ORBIT I Trial
First-in-man study using orbital atherectomy in coronary arteries
Designed to demonstrate safety and performance in calcified coronary lesions
Prospective, single-arm
2 centers OUS
50 subjects
MACE rate
30 days
6 months
2 years
3 years
3/50 (6%)
4/50 (8%)
5/33 (15%)
6/33 (18%)
Cardiac death
0 (0%)
1 (2%)
2 (6%)
3 (9%)
Q-wave MI
New pathological Q-wave greater than 1 mV in 2 or more contiguous leads
Non Q-wave MI
Post-procedure elevation of CK-MB to 3X upper lab normal and no pathological Q-waves on ECG
3 (6%)*
3 (9%)*
TLR
1 (2%)*
1 (3%)*
CONFIDENTIAL
*The same subject experienced TLR and acute non Q-wave MI
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13. ORBIT II Study Design ORBIT II
Prospective, multi-center, single arm study
443 patients enrolled in 49 U.S. hospitals
100 patients enrolled with new electric OAS
Primary Safety Endpoint: 30-Day MACE (PG: 83% freedom from)
Cardiac death
MI defined as CK-MB level > 3 times upper limit of lab normal value
Target vessel revascularization (TVR)
Primary Efficacy Endpoint: Procedural Success (PG: 83% freedom from)
Success in facilitating stent delivery with a final residual stenosis of <50% and without in-hospital MACE
ORBIT II
Study
DIALYSIS
PATIENTS
INCLUDED
EF < 35% INCLUDED
SEVERELY
CALCIFIED
LESIONS
CONFIDENTIAL
Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.

14. Calcification Definitions
ORBIT II severe calcium
Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location. Total length of calcium (including segmented) must be at least 15 mm and extend partially into the target lesion, or
Presence of ≥ 270° of calcium at one cross section via IVUS
SYNTAX Score heavy calcification
Multiple persisting opacifications of the coronary wall visible in more than one projection surrounding the complete lumen of the coronary artery at the site of the lesion
Mintz 1995:
Moderate: radiopacities noted only during the cardiac cycle before contrast injection
Severe: radiopacities noted without cardiac motion before contrast injection generally compromising both sides of the arterial lumen
CONFIDENTIAL

15. ORBIT II Study Results To be presented at ACC 2013
Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360° Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)
Session Title:   Featured Clinical Research I: Interventional
Location:         West, Room 3001
Saturday, March 09, @ 2:15 PM - 2:30 PM
Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
CONFIDENTIAL

16. Proposed Coronary Technique Optimization Study (TOS) US National PI: Dr. Gregg Stone
Coated Tip
1.25mm Classic
1.25mm Micro Solid
Distal and Proximal
Edge Sanding
Non Coated Tip
Non Sanding
Bump
Prospective, multi-center, global study
Up to 400 total patients
30 sites world-wide
IVUS required
OCT encouraged
Japan POC
Randomization 1:1
Short sanding time
Stent deployed at low pressure
Stent deployed at high pressure
Long sanding time
CONFIDENTIAL

17. Questions?