SilverHawk

SilverHawk™
Plaque Excision System
Maximize Lumen Gain
and leave nothing behind
SilverHawk™ Plaque Excision System
The SilverHawk Plaque Excision System from Covidien
luminal gain, and removes plaque from the body.
treats peripheral arterial disease (PAD) by removing
Directional atherectomy with the SilverHawk device
plaque buildup in the arteries of the leg. SilverHawk
enables physicians to maximize lumen gain and minimize
technology incorporates use of a tiny rotating blade that
barotrauma without leaving any implant behind.
shaves plaque from the vessel lumen, thereby enhancing
MICRO EFFICIENT COMPRESSION
(MEC™) TECHNOLOGY
Tiny, laser-drilled nosecone holes
Increase tissue collection capacity,
potentially reducing procedure
time and number of insertions
(LS-M, LX-M, MS-M, SXL, and EXL models)
SILVERHAWK TECHNOLOGY
Engages and treats mild- to
moderately-calcified lesions
and offers the convenience of
on-the-wire cleaning
DEFINITIVE LE
Clinical Summary
The landmark DEFINITIVE LE study is one of the
largest multinational, multicenter PAD device studies
to date, enrolling 800 patients from 47 sites in the U.S.
and Europe. It provides insight into the clinical utility
of directional atherectomy with the TurboHawk™
and SilverHawk devices in a broad range of patients
(diabetics, non-diabetics, claudicants, and those with
critical limb ischemia [CLI]).
DIRECTIONAL ATHERECTOMY MAXIMIZES LUMEN GAIN UNLIKE OTHER THERAPIES1
De Novo Lesion
After Initial Rotational Modality
After Subsequent Directional Modality
Average Area of Lumen
7.0 mm²
Average Area of Lumen
8.2 mm², 17% gain
Average Area of Lumen
15.0 mm², 114% gain
(60 mm length)
(DiamondBack 360° ® 2.25 mm crown)
(60 mm length)
Preserve Future Treatment Options
The Covidien Continuum of Care is based on a treatment
physicians can preserve the native vessel and keep future
philosophy that advocates early detection and treatment of
treatment options open. The Continuum represents the
PAD. We believe that by screening patients at risk for PAD
progression of treatment options—from least invasive to
and treating them early on—by removing the disease—
most invasive / irreversible—for
PAD patients.
™
PAD Continuum of Care
PAD
Screening
Atherectomy
PTA
Stents
Preserves Treatment Options / Less Invasive
DIABETICS VS.
DIABETICS
VS.NON-DIABETICS NON-DIABETICS
1%
DEFINITIVE LE 2
22%
49%
71%
SABETI 3 (BMS)
53%
18%
71%
DERUBERTIS 4 (PTA)
Diabetic
Non-Diabetic
Diabetic
Amputation
Irreversible / Decreases Treatment Options
PRIMARY PATENCY AT 12 MONTHS
12-month Primary
Patency
(%) (%)
12-month
Primary
Patency
77%
78%
Bypass
Non-Diabetic
Diabetic patients show a more positive response to
directional atherectomy than to other therapies.
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
77%
85%
14.4
81% 84%
71%
64%
Diabetic
Non-diabetic
6.5
Mean
Length
(cm)
2.2
< 4 cm
4 - 9.9 cm
≥ 10 cm
Overall, primary patency results are comparable in diabetics vs.
non-diabetics when treating short, medium, and long lesions.
SilverHawk™ Plaque Excision Peripheral Catheters
Catalog
Number
Vessel
Diameter
(mm)
Sheath
Compatibility1
(F)
Crossing
Profile
(mm)
Working
Length2
(cm)
Effective
Length3
(cm)
Tip
Length
(cm)
Max. Cut
Length
(mm)
LS-M
P4052
4.5 to 7.0
7/8
2.7
110
104
6.0
50
LX-M
P4055
4.5 to 6.5
7/8
2.7
113
104
9.0
55
Model Name
Large Vessel | Standard Tip
Large Vessel | Xtended Tip
Packing
Device
MEC™
Tech
Common
Femoral
5 mm - 8 mm
Superficial
Femoral
4 mm - 7 mm
MS-M
P4056
3.5 to 5.0
7/8
2.7
110
104
6.0
50
SXL
P4033
3.0 to 3.5
7
2.4
136
129
7.2
50
P4030
3.0 to 3.5
7
2.3
135
132
2.6
15
Medium Vessel | Standard Tip
Small Vessel | Xtra Long Tip
SS+
Small Vessel | Standard Tip
EXL
Extra Small Vessel | Xtra Long Tip
Popliteal
3 mm - 6 mm
Tibial
Peroneal Trunk
3 mm - 4 mm
Anterior Tibial
2 mm - 4 mm
P4044
2.0 to 3.0
6
2.0
135
129
6.0
15
Peroneal
2 mm - 3 mm
Posterior Tibial
2 mm - 3 mm
ES+
P4034
2.0 to 2.5
6
1.9
135
132
2.2
10
DS
P4028
1.5 to 2.0
6
1.9
135
132
2.6
10
Extra Small Vessel | Standard Tip
Distal Vessel | Standard Tip
Dorsalis Pedis
1.5 mm - 2 mm
MEC Tech is the acronym for Micro Efficient Compression Technology. Max guidewire is 0.014˝ for all SilverHawk devices.
1
Sheath Compatibility - Per the Instructions For Use, the medium vessel and large vessel devices are compatible with 8 F sheaths. A physician survey of device usage
indicated 7 F sheaths may have an Internal Diameter (ID) that will accommodate the crossing profile of the LX-M, LS-M, and MS-M (non-flush tip) devices. Data on file
with manufacturer.
2
Working Length - distal end of strain relief to the distal end of tip.
3
Effective Length - distal end of strain relief to the proximal end of cutter window.
1. Aboufakher R, Tory J, Szpunar S, et
al. Peripheral Plaque Volume Changes
Pre- and Post-rotational Atherectomy
followed by Directional Plaque
Excision: Assessment by Intravascular
Ultrasound and Virtual Histology.
J Invasive Cardiol. 2009; 21: 201-205.
2. Garcia L. DEFINITIVE LE 12
Month Final Results. VIVA 2012.
Las Vegas, NV.
3. Sabeti S, Mlekusch W, Amighi J, et
al. Primary Patency of Long-segment
Self-expanding Nitinol Stents in the
Femoropopliteal Arteries. J Endovasc
Ther. Feb 2005;12(1):6-12.
Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
4. DeRubertis BG, Pierce M, Ryer EJ,
et al. Reduced Primary Patency Rate
in Diabetic Patients after Percutaneous
Intervention Results from More
Frequent Presentation with Limbthreatening Ischemia. J Vasc Surg.
Jan 2008;47(1):101-108.
COVIDIEN, COVIDIEN with logo, Covidien
logo, and positive results for life are
trademarks of Covidien AG.
Other brands are trademarks
of a Covidien Company.
©2013 Covidien.
114763-001 (B) JAN/13
Peripheral Vascular
3033 Campus Drive, n550
Plymouth, MN
55441
ph +1 763 398 7000
fx +1 763 398 7001
cs +1 800 716 6700
www.covidien.com