SilverHawk

Plaque Excision System

 Maximize Lumen Gain
and leave nothing behind

SilverHawk Plaque Excision System

The SilverHawk Plaque Excision System from Covidien
treats peripheral arterial disease (PAD) by removing
plaque buildup in the arteries of the leg. SilverHawk
technology incorporates use of a tiny rotating blade that
shaves plaque from the vessel lumen, thereby enhancing
luminal gain, and removes plaque from the body.
Directional atherectomy with the SilverHawk device
enables physicians to maximize lumen gain and minimize
barotrauma without leaving any implant behind.

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 DEFINITIVE LE

Engages and treats mild- to Clinical Summary
moderately-calcified lesions
and offers the convenience of The landmark DEFINITIVE LE study is one of the
on-the-wire cleaning 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
(60 mm length) (DiamondBack 360 2.25 mm crown) (60 mm length)

Average Area of Lumen Average Area of Lumen Average Area of Lumen

7.0 mm 8.2 mm, 17% gain 15.0 mm, 114% gain

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 optionsfrom least invasive to
and treating them early onby removing the disease most invasive / irreversiblefor PAD patients.
PAD Continuum of Care

PAD
Atherectomy PTA Stents Bypass Amputation
Screening

Preserves Treatment Options / Less Invasive Irreversible / Decreases Treatment Options

DIABETICS VS.
DIABETICS VS.NON-DIABETICS
NON-DIABETICS PRIMARY PATENCY AT 12 MONTHS
12-month Primary
12-month PrimaryPatency (%) (%)
Patency
100%
77%
1% 90% 85% 14.4
78% 77% 81% 84%
80%
DEFINITIVE LE 2 71% Diabetic
70% 64%
22% 60%
49% Non-diabetic
71% 50%
SABETI 3 (BMS) 40% 6.5
30% Mean
53% Length
18% 20% 2.2 (cm)
71% 10%
DERUBERTIS 4 (PTA)
0%
Diabetic Non-Diabetic Diabetic Non-Diabetic < 4 cm 4 - 9.9 cm 10 cm
Diabetic patients show a more positive response to Overall, primary patency results are comparable in diabetics vs.
directional atherectomy than to other therapies. non-diabetics when treating short, medium, and long lesions.
 SilverHawk Plaque Excision Peripheral Catheters
Vessel Sheath Crossing Working Effective Tip Max. Cut
Catalog Packing MEC
Model Name Number Diameter Compatibility1 Profile Length2 Length3 Length Length Device Tech Common
(mm) (F) (mm) (cm) (cm) (cm) (mm) Femoral
5 mm - 8 mm

LS-M P4052 4.5 to 7.0 7/8 2.7 110 104 6.0 50

Large Vessel | Standard Tip

LX-M P4055 4.5 to 6.5 7/8 2.7 113 104 9.0 55

Large Vessel | Xtended Tip
Superficial
Femoral
4 mm - 7 mm
MS-M P4056 3.5 to 5.0 7/8 2.7 110 104 6.0 50
Medium Vessel | Standard Tip

SXL P4033 3.0 to 3.5 7 2.4 136 129 7.2 50

Small Vessel | Xtra Long Tip Popliteal
3 mm - 6 mm

SS+ P4030 3.0 to 3.5 7 2.3 135 132 2.6 15 Tibial

Small Vessel | Standard Tip Peroneal Trunk
3 mm - 4 mm
Anterior Tibial
2 mm - 4 mm
EXL P4044 2.0 to 3.0 6 2.0 135 129 6.0 15
Extra Small Vessel | Xtra Long Tip 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
Extra Small Vessel | Standard Tip

Dorsalis Pedis
DS 1.5 mm - 2 mm
Distal Vessel | Standard Tip
P4028 1.5 to 2.0 6 1.9 135 132 2.6 10

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 prole of the LX-M, LS-M, and MS-M (non-flush tip) devices. Data on le
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.
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 Limb-
threatening Ischemia. J Vasc Surg.
Jan 2008;47(1):101-108.

Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. COVIDIEN, COVIDIEN with logo, Covidien
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. 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 ph +1 763 398 7000 www.covidien.com
Plymouth, MN fx +1 763 398 7001
55441 cs +1 800 716 6700