1. Debulking Below the Knee: Devices & Techniques
Jihad A. Mustapha, MD, FSCAI, FACC
Advanced Cardiac & Vascular Centers for Amputation Prevention
Grand Rapids, MI

2. Disclosures Bard Peripheral Vascular – Consultant
Boston Scientific – Consultant, Scientific Advisory Board, Research
CardioFlow – Equity, Research
Cardiovascular Systems, Inc. – Consultant, Research
Medtronic – Consultant
Micromedical Solutions – Chief Medical Officer
Philips – Consultant
PQ Bypass – Research
Reflow Medical – Chief Medical Officer
Terumo - Consultant

3. Atherectomy Devices Jetstream™ Atherectomy System (Boston Scientific)
Peripheral Rotablator™
Rotational Atherectomy System
Diamondback 360™, Stealth 360™ Atherectomy System
(Cardiovascular Systems, Inc)
SilverHawk™, TurboHawk™
Plaque Excision System
(Covidien)
Turbo-Elite™
Laser Atherectomy Catheter
(Spectranetics)
Front-Cutting 
N/A
Differential Cutting
Active Aspiration
Concentric Lumens
Lesion Morphology:
Calcium
Soft/Fibrotic Plaque
Thrombus
Sources: Endovascular Today Buyer’s Guide JETSTREAM System Brochure, Boston Scientific Website, Peripheral Rotablator product website, Boston Scientific, Diamondback 360 product website, CSI, Covidien website, Directional Atherectomy products, Turbo-Elite Laser Atherectomy Catheter Instructions for Use, May 2014.

4. The LACI Trial: 6 Month Results
The LACI Studies
The LACI Trial: 6 Month Results
Laird et al
145 pt, 155 critical ischemic limbs
423 lesions
41%SFA, 15% Popliteal, 41% Infrapop
70% of Pts had combo occlusion and stenosis
29% Rutherford Class 4
71% Rutherford Class 5 or 6
Limb salvage 92% at 6 months

5. DEFINITIVE LE Study Design and Oversight:
Prospective, non-randomized, global study
800 subjects enrolled at 47 centers
CEC and Steering Committee oversight and CEC adjudicaiton
Angiographic and Duplex core laboratory analyses
Inclusion Criteria
RCC 1-6
≥ 50% stenosis
Lesion lengths up to 20cm
Reference Vessel ≥ 1.5 mm and ≤ 7.0 mm
Exclusion Criteria
Severe calcification
In-stent restenosis
Aneurysmal target vessel

6. Lesion Assessment McKinsey JF et al JACC Interv 2014 Core lab reported
Characteristic
Claudication (RCC 1-3)
CLI
(RCC 4-6)
All Subjects (RCC 1-6)
Number of Patients
598
201
799
Number of Lesions
743
279
1022
Mean Length (cm)
7.5
7.2
7.4
Baseline Stenosis (%) 73 76 74
Occlusions (%) 17 30 21
Anatomic location based on proximal edge of lesion treatment, % (N)
SFA
72% (536)
48% (135)
66% (671)
Popliteal
15% (114)
17% (48)
16% (162)
Infrapopliteal
13% (93)
34% (96)
18% (189)
Statistically significant differences: target artery distribution (collectively), occlusions, and baseline stenosis
McKinsey JF et al JACC Interv 2014
Core lab reported

7. Primary Patency in Subgroups
Claudicants (n=743)
CLI (n=279)
Patency
(PSVR < 2.4)
Lesion Length (cm)
All (n=1022)
78%
7.5
71%
7.2
Lesion type
Stenoses (n=806)
81%
6.7
73%
5.8
Occlusions (n=211)
64%
11.1
66%
10.3
Lesion Location
SFA (n=671)
75%
8.1
68%
8.6
Popliteal (n=162)
77%
6.0
5.4
Infrapopliteal (n=189)
90%
5.5

8. Primary Patency in Subgroups
Claudicants (n=743)
CLI (n=279)
Patency
(PSVR < 2.4)
Lesion Length (cm)
All (n=1022)
78%
7.5
71%
7.2
By Lesion Length
< 4 cm (n=318)
81%
2.2
84%
2.3
4-9.9 cm (n=418)
83%
6.5
62%
6.6
≥ 10 cm (n=283)
67%
14.4
65%
15.1
SFA Only By Lesion Length
< 4 cm (n=184)
82%
4-9.9 cm (n=253)
60%
6.9
≥ 10 cm (n=232)
14.6
63%
15.5
If we lose TASC and add SFA lesions alone <4, and over 10 cm. SFA proximal is 24%, mid is 50%, distal is 26% of total SFA lesions.

9. Jetstream System Overview
XC 2.1/3.0mm
XC 2.4/3.4 mm
SC 1.85mm
JETSTREAM XC Catheters
JETSTREAM SC Catheters
(Tibial Sizes)
(SFA & Popliteal Sizes)
SC 1.6mm
Control POD
Console
Over-the-Wire
Approved for use with BSC 0.014” 300cm Thruway Guidewire
Approved for use with Atherectomy Lubricants, such as Rotaglide

10. Patient Characteristics
241 patients (258 lesions)
Overall
(N=241)
Age (years), mean ± SD
67.1 ± 9.8
Male
66.0%
Medical History
Hypertension
82.6%
Hypercholesterolemia
66.8%
Smoking
50.6%
Heart Disease
47.7%
Diabetes
41.1%
Race
Caucasian
80.1%
African American
16.6%
Native American
2.1%
Other
1.2%

11. Lesion Characteristics
aPost hoc analysis of patients who received and did not receive adjunctive stents.
bCalcium grading: 0= no visible calcification; 1= one individual segment of vessel calcification representing <25% of the length of the entire segment; 2= aggregate calcification representing <50% of the segment length; 3= aggregate calcification representing >50% of the segment length; 4= dense circumferential calcification along the segment length.
Overall
(N=258 lesions)
Non-Stenta
(N=165 lesions)
Stenta
(N=93 lesions)
Lesion location
Superficial Femoral
75.6%
72.1%
81.7%
Common Femoral
10.9%
15.2%
3.2%
Popliteal
13.6%
12.7%
15.1%
Lesion length, mean ± SD
16.4 ± 13.6 cm
14.1 ± 12.6 cm
20.5 ± 14.4 cm
Calcium Gradeb
10.0%
10.2%
9.5% 1
16.2%
14.6%
19.0% 2
24.1%
17.8%
35.7% 3
28.2%
31.8%
21.4% 4
19.5%
21.0%
16.7%
Lesion RVD, mean ± SD
5.7 ± 0.9 mm
5.5 ± 0.9 mm
5.9 ± 0.9 mm
Occlusion (100% stenosis)
36.1%
28.7%
50.0%
Pre-treatment stenosis estimate, mean ± SD
91.1% ± 9.8%
90.2% ± 10.0%
92.7% ± 9.4%

12. Procedures
98.3% procedural success (≤30% residual diameter stenosis post- procedure)
84 patients (35%) received adjunctive stents
Stent placement performed at operator’s discretion
Embolic protection used in 22.4% of cases
Procedure time:
73.4 ± 37.5 min
Total Jetstream
run time:
4.7 ± 3.5 min
Number of Passes
Blades Down:
2.0 ± 1.5
Blades Up:
1.8 ± 1.4
 Post-treatment stenosis estimate, mean ± SD
Overall
(N=258 lesions)
Non-Stent
(N=165 lesions)
Stent
(N=93 lesions)
Post-Jetstream
44.4% ± 20.0%
38.5% ± 16.2%
54.8% ± 22.0%
Post Adjunctive Treatment
9.8% ± 11.4%
11.6% ± 11.7%
6.6% ± 10.2%

13. Unique Mechanism of Action Preferential Sanding
Elastic healthy tissue “gives” and is not affected by diamond grit
Diseased tissue provides resistance and allows grit to “sand” the plaque
Effective plaque removal
No detrimental effect
Diamond Grit
Diseased Tissue
Compliant Tissue

14. 6 month data
124 patients for infrapopliteal revascularization (201 lesions)
Claudicants 55%
CLI 45%
Treatment OA either stand alone or with adjuctive Rx

15. `

16. LIBERTY 360
Prospective, observational, multi-center clinical study to evaluate acute and long-term clinical, functional and economic outcomes of endovascular device intervention in patients with distal outflow peripheral arterial disease (PAD)
No inclusion and exclusion
Independent core laboratory analyses and adjudications
Angiographic
Duplex Ultrasound
Six Minute Walk Test
Health Economics
Includes separate analyses for
Claudicants
Critical limb ischemia (RB4 and 5)
Critical limb ischemia (RB6)

17. Device Usage by Lesion Balloon and/or atherectomy were preferred devices.
*Bailout stent group is a subset of Stent group. Bailout stent defined as stent placed due to an angiographic complication or sub-optimal result (>50% stenosis).
Core Lab reported lesions.
Patients with reported values may be less than total number of patients enrolled in each arm.
Comparison between Rutherford
categories significant (p<0.05)

18. Major Adverse Events (MAEs) to 6 Months High freedom from 6-Month Major Adverse Events (MAE), indicating even RC6 subjects can be treated with PVI.
Major Adverse Event defined as:
Death (within 30 days of the index procedure)
Unplanned major amputation of the target limb (above the ankle)
Clinically-driven TVR (inclusive of TLR) of the target limb
Kaplan-Meier method used to obtain estimate of freedom from MAE.
Greenwood’s method used to obtain the 95% confidence interval for the estimate.
Pairwise Log-Rank P-values at 180-Days: RC2-3 vs. RC4-5, P<0.0001; RC2-3 vs. RC6, P<0.0001; RC4-5 vs. RC6, P=0.0453

19. 6-Month Freedom from MAEs
92.6%
At Risk
414
Events 35
Censored 50
81.2%
At Risk
406
Events
102
Censored 81
73.7%
At Risk 54
Events 23
Censored 22
6-Month
RC2-3 vs. RC4-5
RC2-3 vs. RC6
RC4-5 vs. RC6
Hazard Ratio P
MAE
0.40 [0.29, 0.56]
<0.0001
0.26 [0.16, 0.41]
0.63 [0.42, 0.95]
0.0271
(Point Estimate and 95% Confidence Intervals)
Kaplan-Meier method used to obtain estimate of freedom from MAE.
Greenwood’s method used to obtain the 95% confidence interval for the estimate.

20. 6-Month Freedom from MAE Components
Death
Major Amputation
TVR
97.1%
99.8%
93.0%
RC 2-3
95.3%
96.8%
83.1%
RC 4-5
RC 6
85.1%
87.1%
85.1%
RC 2-3
RC 4-5
RC 6
At risk
446
498 66
Events 14 26 13
Censored 39 65 20
RC 2-3
RC 4-5
RC 6
At risk
445
485 61
Events 1 18 11
Censored 53 86 27
RC 2-3
RC 4-5
RC 6
At risk
414
411 59
Events 33 91 12
Censored 52 87 28
For calculation of MAE rate, death capped at 30 days.
Cox proportional hazards model identifies no difference between any RC group/arm at 6 months.
Point Estimate and 95% Confidence Intervals
Kaplan-Meier method used to obtain estimate of freedom from MAE.
Greenwood’s method used to obtain the 95% confidence interval for the estimate.

21. Phoenix catheter 5 Fr, OTW, front cutting atherectomy
Rotational speed RPM
Debris withdrawn through Archimedes screw system
EASE trial >100 patients, 0.8% embolic events

22. Pantheris VISION trial 91.4% treated stand alone Pantheris
130 pts
55 (24 month results)
91.4% treated stand alone Pantheris
9.6% DCB
5.1% stent
82% freedom from TLR at 24 months

23. DEFINITIVE AR Study Design
Purpose: assess and estimate the effect of treating a vessel with directional atherectomy + DCB (DAART) compared to treatment with DCB alone
Registry arm for severely calcified lesions created to limit bail-out stenting (and therefore variables) in randomized arm.
General and Angiographic Criteria Assessment
Lesion severely calcified?
Guidewire passage, enrollment & Randomization
DAART*
(N = 48)
DCB
(N = 54)
Guidewire Passage & Enrollment
(N=19) No
Severe Calcification: Dense circumferential calcification and calcification extending more than five (5) continuous centimeters of length prior to contrast injection or digital subtraction angiography
There was 6 month lag in ca++ arm due to prolonged enrollment period. Acute results from the ca++ arm will be presented soon.
The sample size difference between groups is attributed to the blocked randomized trial design.
Yes
* Directional Atherectomy + Anti-Restenotic Therapy

24. Clinical Limitations & Unmet Needs
Calcium as a Barrier
Longer Lesion Length
Calcium Limits Vessel Expansion1
Calcium May Limit Drug Effect2
Increased lesion length is an independent predictor of decreased patency5.
1Freed MS, Manual of Interventional Cardiology, 2Fanelli DEBELLUM, 3Laird, CCI, June 2010, 4SMART Control IFU, 5Matusumura, DURABILITY IIJVS, July 2013, 6Davaine,
European Journal of Vascular and Endovascular Surgery 44 (2012)

25. Baseline Lesion Characteristics Per Core Lab
Baseline Characteristics
DAART
(N= 48)
DCB
(N = 54)
p-Value*
Severe Ca++ Arm
(N=19)
Lesion Length (cm)
11.2
9.7
0.05
11.9
Diameter Stenosis
82%
85%
0.35
88%
Reference vessel diameter (mm)
4.9
0.48
5.1
Minimum lumen diameter (mm)
1.0
0.8
0.34
0.7
Calcification
70.8%
74.1%
0.82
94.7%
Severe calcification
25.0%
18.5%
89.5%
* p-value for DAART and DCB groups

26. Key Study Outcome at 12 Months - Angiographic Patency shows similar pattern
N = N = 39
N = N = 16
N = N = 7
Results for all patients who returned for angiographic follow-up

27. What’s out there and what to choose?
Several devices now available for debulking
Critical question remains is debulking part of vessel prep “all” or “some” of the time
Each device has compelling data
Some better for calcific disease
Some better for ease of use
There is no question that in some cases either for DCB or stenting a debulking strategy is critical to obtain best initial and probably long- term outcomes
Combined therapy appear compelling though not fully tested