SAN FRANCISCO—Results from ORBIT II, a clinical trial designed to evaluate the safety and efficacy of the Diamondback 360° Orbital Atherectomy System to treat de novo severely calcified coronary lesions, were presented March 9 at the American College of Cardiology (ACC) scientific session.

1. 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)
Jeff Chambers, MD
Director of Research
Cardiac Catheterization Lab Director
Metropolitan Heart and Vascular Institute
Mercy Hospital, Minneapolis, MN
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

2. Severe Coronary Calcium is Under
Estimated and Under Appreciated
• Despite being a relatively common problem there
have been no FDA IDE PMA trials studying only
patients with severe coronary calcification
• Due to poor clinical outcomes, including higher
MACE and angiographic complications, patients
with severe calcium have been excluded from
almost all large scale clinical trials.

3. Complications
• Calcified Lesions
 Prone to dissection during balloon angioplasty or
pre-dilatation1
 Difficult to completely dilate2
 Can prevent adequate stent expansion3
 Preclude stent delivery to the desired location4
1 Fitzgerald PJ, et al.. Circulation. 1992:86;64-70. Kahn J, et al. Cathet Cardiovasc Diagn. 1990;21:89-91.
2 Cavusoglu E, et al. Cathet Cardivasc Intervent. 2004;62:485-498
3 Moussa I, et al. Circulation. 1997;96(1):128-136..
4 Gilutz H, et al. Cathet Cardiovasc Intervent. 2000;50:212-214.

4. Outcomes in Calcified Lesions
Unstudied population
Type of Calcification
Publication Severe Calcium / Total Pts
Reported
Dill Eur Heart J, 2000 98 / 249 Calcified
Safian CCI, 2001 54 / 254 Calcified
Doshi AJC, 2003 557 / 843 Moderate/severe
Mosseri CRM, 2005 75 / 540 Severe
Clavijo CCI, 2006 81 / 81 Heavy
Note: Includes retrospective data and lack of core lab adjudication
Weighted Average Procedural Success = 84%
Weighted MACE Rate at 30 days = 15.9%
3

5. ORBIT II
Pivotal Trial to Evaluate the Safety and Efficacy of the
Diamondback 360° Orbital Atherectomy System in
Treating De Novo, Severely Calcified Coronary Lesions
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

6. Orbital Technology for Calcified
Coronary Arteries
 Easy setup and use
 Control of device in operating field
 .012” OAS guide wire
 Compatible with 6 French guiding catheters
Eccentric Crown Electric OAS
Electric OAS
ViperWire™
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

7. Unique Mechanism of Action
Differential Orbital Sanding
Crown will only Soft components
sand the hard (plaque/tissue)
components of flex away from
plaque crown
Orbital Mechanism
• Increased speed = Increased centrifugal force
• Greater centrifugal force = Larger orbital diameter
CF=Mass×Rotational speed2
Radius of the orbit
Actual results may vary depending on
device-to-lumen ratio, run time and
speed, and plaque morphology.

8. Unique Mechanism of Action
• Orbiting Crown Enables
• Continuous flow of blood and saline
• Minimizes thermal injury
• Potentially decreases no-reflow and periprocedural
cardiac enzyme elevation
• One crown treats different vessel diameters based
on orbiting speed
Actual results may vary depending on
device-to-lumen ratio, run time and
speed, and plaque morphology.

9. Coronary OAS Mechanism Of Action
• Video
*Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

10. ORBIT II Study Design
• To evaluate safety and efficacy of coronary OAS to prepare
de novo severely calcified coronary lesions for enabling stent
placement
 Prospective
 Multi-center trial
 Single arm - FDA recommendation as there are no FDA-approved
percutaneous treatments for patients with severely calcified lesions.
443 patients enrolled in 49 US sites
30 days follow-up
Complete in 97.7% (N=430/440)
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

11. The ORBIT II Trial: Primary Endpoints
Primary Safety Endpoint: 30-Day MACE
• MI defined as CK-MB level > 3 times ULN
• Target vessel revascularization (TVR)
• Cardiac death
Primary Efficacy Endpoint: Procedural Success
• Success in facilitating stent delivery with a final
residual stenosis of <50% and without in-hospital
MACE
In Hospital MACE Impacts Both Primary Endpoints
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

12. Inclusion Criteria
• The target lesion must be a de novo coronary lesion
that has not been previously treated with any
interventional procedure.
• The target vessel reference diameter must be
≥ 2.5mm and ≤ 4.0mm.
• The target lesion must not exceed 40mm.
• The target vessel must have a TIMI 3 flow at baseline.
• The target lesion must have fluoroscopic or IVUS
evidence of severe calcium deposit at the lesion site
based on the protocol definition
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

13. ORBIT II Severe Calcification Definition:
Only Includes The Most Severely Calcified Lesions
Mintz1 1995 calcium definition
• 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
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
1. Mintz , et al. Circulation. 1995 Apr 1;91(7):1959-65.

14. Exclusion Criteria
• Diagnosed with chronic renal failure unless under hemodialysis, or has
a serum creatinine level >2.5 mg/dl.
• Evidence of current LVEF ≤25% (where current is defined as the latest
LVEF measurement completed within the last 6 months).
• Subject with angiographically confirmed evidence of more than
1 lesion requiring intervention, unless the treatment of the lesions is
staged.
• Target vessel has a stent from previous PCI unless 1) the stent was
implanted greater than 30 days prior to the index procedure, and 2) the
stent has no higher than 30% in-stent stenosis, and 3) the stent is on a
different branch than the target lesion.
• Target lesion is an ostial location (within 5 mm of ostium) or an
unprotected left main lesion.
• Target lesion is a bifurcation or has a ≥ 1.5 mm side branch.
• Target lesion has thrombus or dissection.
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

15. ORBIT II: Demographics & Characteristics
Demographics N=443
Male 64.6%
Age (yrs) 71.4
History of diabetes mellitus 36.2%
History of CABG 14.7%
History of dislipidemia 91.9%
History of hypertension 91.6%
Smoker (current or previous) 66.1%
Vessel & Lesion Characteristics
Mean pre-procedure target lesion length 18.9 mm
Mean pre-procedure percent stenosis 84.4%
IVUS degree of calcium (35/440, 8%) 270-360°
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

16. ORBIT II: Primary Safety Endpoint
30 Day MACE Rate Components:
MI (CK-MB >3x ULN): 9.7%
Non Q-wave 8.8%
Q-wave 0.9%
TVR/TLR: 1.4%
TVR 0.7%
TLR 0.7%
Cardiac death: 0.2%
Performance Goal = 83%
Freedom from 30 Day
MACE = 89.8%
(95% CI = 87.0%, 92.7%)
80% 85% 90% 95% 100%
Caution – Investigational Device.
Results based on Clinical Events
Limited by Federal (or United States)
Committee adjudication
law to investigational use.

17. ORBIT II: Primary Efficacy Endpoint
Procedural Success Components:
Successful Stent delivered: 97.7%
Less than 50% residual stenosis: 98.6%
In hospital MACE: 9.5%
MI (CK-MB >3x ULN): 9.3%
Non Q-wave 8.6%
Q-wave 0.7%
TVR: 0.7%
Cardiac death: 0.2%
Performance Goal = 82% Procedural Success =
89.1%
(95% CI = 85.8%, 91.8%)
80% 85% 90% 95% 100%
Caution – Investigational Device.
Results based on Clinical Events
Limited by Federal (or United States)
Committee adjudication
law to investigational use.

18. Non Q Wave MI in Severely Calcified Lesions
Mosseri (2005)1 Clavijo (2006)2 ORBIT II
Orbit II calcium
Mintz 1995 calcium definition Mintz 1995 calcium definition
definition
n = 662 n = 150 n = 443
30% Increasing calcium deposits 30 30
increases the incidence of non 25.8%
25% Q-wave MI 25 25
20.9% 19.8%
20% 20 20
15% 12.3% 15 15
9.8%
10% 8.0% 10 10 8.6%
5% 5 5
0% 0 0
0-90° 91-180° 181-270° 271-360° SES RA+SES OAS+DES/BMS
n = 315 n = 186 n = 86 n = 75 n = 69 n = 81 n = 443
1.Mosseri, et al. Cardiovascular
Caution – Investigational Device.
Revascularization Medicine. 2005. 6:147-153.
Limited by Federal (or United States)
2. Clavijo, et al. Catheterization and law to investigational use.
Cardiovascular Interventions. 2006. 68:873–878 Data on file at CSI.

19. Death Rates in Severely Calcified Lesions
3
2.6% Clavijo 2006
2.5 (SES)
2 Clavijo 2006
1.7% (RA+SES)
1.5%
1.5
Mosseri
1 2005(BMS)
0.5 ORBIT II
0.2%
(OAS+DES/BMS)
0
Mortality (%) 30 day
1. Clavijo, et al. Catheterization and Cardiovascular *Caution – Investigational Device.
Interventions. 2006. 68:873–878 Limited by Federal (or United States)
2.Mosseri, et al. Cardiovascular Revascularization law to investigational use.
Medicine. 2005. 6:147-153. Data on file at CSI.

20. 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 with >90⁰ of calcium via IVUS
• Compared to ORBIT II
• Shorter lesions
• Less B2/C lesions
30 days1 6 months1 2 years2 3 years2
MACE rate
3/50 (6%) 4/50 (8%) 5/33 (15%) 6/33 (18.2%)
Cardiac Death 0 (0%) 1 (2%) 2 (6%) 3 (9.1%)
Q-wave MI 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Non Q-wave MI 3 (6%) 3 (6%) 3 (9%) 3 (9.1%)
TLR 1 (2%) 1 (2%) 1 (3%) 1 (3%)
1. Parikh, K. et al. Safety and feasibility of orbital
atherectomy for the treatment of calcified
coronary lesions: The ORBIT I Trial.Catheter Caution – Investigational Device.
Cardiovasc Interv. 2013 Mar 5. Limited by Federal (or United States)
2. Parikh, K. et al. JACC:Cardiovascular law to investigational use.
Interventions, Vol. 6, No. 2, Suppl s, 2013

21. ORBIT II Case Studies: LCX (Baseline)
Female, 70 years old
History of DM, smoker,
dyslipidemia, HTN, EF 50%,
Positive stress test
Lesion length 24 mm
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

22. ORBIT II Case Studies: LCX (Treatment)
1.25 mm Crown
With Electric OAD
Low Speed, 15
Seconds
High Speed, 15
Seconds
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

23. ORBIT II Case Studies: LCX (Post OAS)
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

24. ORBIT II Case Studies: LCX (Final)
Single DES
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.

25. Conclusion
• The ORBIT II trial was unique in enrolling only patients with
severely calcified coronary arteries
• The ORBIT II trial met the primary safety and efficacy
endpoints by a significant margin
• There was a decrease in the incidence of MACE (mortality, MI
and TVR) in comparison to the historical controls when this
device was used
• The improvement in clinical outcome might be attributed to
the unique mechanism of action of OAS
• OAS is a technology that may address an unmet treatment
need for this difficult to treat patient population
Caution – Investigational Device.
Limited by Federal (or United States)
law to investigational use.