Turbohawk

TurboHawk™
Plaque Excision System
DIABETICS VS. NON-DIABETICS Twelve-month Patency
in Diabetics
12-month Primary Patency (%)
Diabetic patients show
a more positive response
to directional atherectomy
than to other therapies
77%
78%
1%
DEFINITIVE LE1
22%
49%
71%
SABETTI2 (BMS)
Diabetic
53%
Non-diabetic
18%
71%
Diabetic
Non-diabetic
DERUBERTIS3 (PTA)
DEFINITIVE LE Clinical Study
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, nondiabetics, claudicants, and those with critical
limb ischemia [CLI]).
Twelve-month
Primary Patency
Overall, primary patency results
are comparable in diabetics vs.
non-diabetics when treating
short, medium, and long lesions
Key 12-month clinical findings from DEFINITIVE LE:
• Directional atherectomy is as effective in treating claudication in
diabetics as in non-diabetics
• Treatment with directional atherectomy delivers 12-month
patency of 78%, which is comparable to patency rates reported in
stenting studies–without leaving a foreign implant behind in the
vessel–and preserves future treatment options for patients
• Directional atherectomy is a viable option for treating PAD in
“no-stent” zones where stents may be subjected to constant torsion
and flexion
• Directional atherectomy achieves a limb salvage rate of 95% at
12 months in CLI patients
primary patency at 12 months
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
Maximize Lumen Gain,
Maximize Results
One Platform to Maximize Results
The TurboHawk™ Plaque Excision System is Covidien’s most advanced
directional atherectomy platform to treat peripheral arterial disease
(PAD). The new High Efficiency Cutter is now available to treat the
toughest lesions above and below the knee. Treat PAD with technology
that maximizes lumen gain, preserves a patient’s native vessels, and
keeps future treatment options open.
Select a Cutter to
Meet Procedural Needs
High Efficiency (HE) Cutter
Four contoured blades
Engage and treat all plaque
morphologies, including
heavy calcium*
Remove more disease with
each pass, maximizing lumen gain
HE Cutter
Smooth Cutter
Lesion Morphology
All morphologies, including
heavily calcified lesions*
Mild- to moderately-calcified
lesions
Disease Removal
Distal Flush Tool
On-the-wire cleaning
TurboHawk Model
Name
(Vessel Range)
Large vessel: LS-C, LX-C
3.5 mm to 7.0 mm
Large vessel: LS-M, LX-M
3.5 mm to 7.0 mm
Small vessel: SX-C, SS-C, SS-CL
2.0 mm to 4.0 mm
––
Drive shaft
Higher powered, counter-wound drive shaft
Transmits power more efficiently to the
contoured cutter blades
Spin Percentage Comparison*
94%
TurboHawk catheter drive shaft
Tapered tip
Low profile, tapered tip
50%
SilverHawk™ catheter drive shaft
N=20
Provides enhanced deliverability
*Data on file
Small Vessel TurboHawk catheter
Large Vessel TurboHawk catheter
Maximize Procedural Efficiency
Micro Efficient Compression
(MEC™) Technology
Tiny, laser-drilled nosecone holes
MEC Technology Tissue Capture*
Increase tissue collection capacity,
potentially reducing procedure
time and number of insertions
MEC Catheter
103 mg
71 mg
Non-MEC Catheter
32%
MEC Technology
N=7
*Data on file
increase in the catheter’s tissue collection capacity with MEC technology
Dual catheter jog
Versatile, dual catheter jog
Cutter Apposition Comparison*
Ensures consistent cutter contact in a wide
range of vessels
0.08
Reduces the need for multiple catheter use
0.06
Apposition Force (lb)
Improved apposition
force in larger vessels
TurboHawk
device
SilverHawk
device
Same apposition force as
the SilverHawk device
in smaller vessels
0.04
0.02
0.00
3
4
5
6
7
8
N=34
Vessel Diameter (mm)
*Data on file
Catheter Alignment marker
Provides easy alignment of the nosecone in the
flush tool for faster cleaning
Cleaning Effectiveness*
Test Units Cleaned on First Flush (%)
80%
HE Cutter
improvement
in cleaning
20%
Super Cutter
*Data on file
400%
N=5
New Distal Flush Tool
Offers increased pressure during cleaning for effective flushing
TURBOHAWK™ Plaque excision system PLATFORM
Catalog
Number
LS-C High Efficiency Cutter
Large Vessel | Standard Calcium Tip
THS-LS-C
3.5 to 7.0
7
2.7
110
104
6.0
50

LX-C High Efficiency Cutter
Large Vessel | Xtended Calcium Tip
THS-LX-C
3.5 to 7.0
7
2.7
113
104
9.0
75

Large Vessel | Standard Tip
Large Vessel | Xtended Tip
SX-C High Efficiency Cutter
SMALL VESSEL
Small Vessel | Xtended Calcium Tip
Working
Length1
(cm)
Effective
Length2
(cm)
Tip
Length
(cm)
Max. Cut
Length
(mm)
Packing
Device
TH-LS-M
3.5 to 7.0
7/8
2.7
110
104
6.0
50

TH-LX-M
3.5 to 7.0
7/8
2.7
113
104
9.0
75

THS-SX-C
2.0 to 4.0
6
2.2
135
129
5.9
40
SS-C High Efficiency Cutter
Small Vessel | Standard Calcium Tip
THS-SS-C
2.0 to 4.0
6
2.2
133
129
3.9
20
SS-CL High Efficiency Cutter
Small Vessel | Standard Calcium Tip
Long Catheter
THS-SSCL
2.0 to 4.0
6
2.2
149
145
3.9
20
SilverHawk DS
Distal Vessel | Standard Tip
2
Crossing
Profile
(mm)
Common
Femoral
5 mm – 8 mm
Superficial
Femoral (SFA)
4 mm – 7 mm
Popliteal
3 mm – 6 mm

Tibial
Peroneal Trunk
3 mm – 4 mm
SX-C, SS-C, SS-CL
LS-M Smooth Cutter
Sheath
Compatibility
(F)
LS-C, LX-C, LS-M, LX-M
Model Name
LX-M Smooth Cutter
1
TurboHawk Models
Vessel
Diameter
(mm)
Anterior Tibial
2 mm – 4 mm
Peroneal
2 mm – 3 mm
Posterior Tibial
2 mm – 3 mm
P4028
1.5 to 2.0
6
1.9
135
132
2.6
DS
LARGE VESSEL
Directional Atherectomy Peripheral Catheters
10
Dorsalis Pedis
1.5mm – 2 mm
Working Length - distal end of strain relief to the distal end of tip.
Effective Length - distal end of strain relief to the proximal end of cutter window.
REFERENCES
1. Garcia L. DEFINITIVE LE Determination of
EFfectiveness of the SilverHawk PerIpheral Plaque
ExcisioN System (SIlverHawk Device) for the
Treatment of Infrainguinal VEssels / Lower
Extremities 12-month Final Results. VIVA 2012.
2. 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.
3. 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.
DEFINITIVE LE stands for Determination of EFfectiveness of the SilverHawk™ PerIpheral Plaque
ExcisioN System (SIlverHawk) for the Treatment of Infrainguinal VEssels / Lower Extremities.
Find out more about TurboHawk innovations, systems, and clinical results at www.turbohawkdevice.com.
*Large vessel catheters: When used in hard, complex calcified lesions the TurboHawk catheter should be paired with the SpiderFX™ Embolic Protection Device
to mitigate the risk of distal embolization.
Small vessel catheters: Do not use in hard, complex calcified lesions due to the risk of distal embolization that may result from excising this type of lesion.
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.
COVIDIEN, COVIDIEN with logo, Covidien
logo, and positive results for life are
trademarks of Covidien AG.
TurboHawk and SilverHawk are
trademarks of a Covidien Company.
©2012 Covidien.
116300-001(A) SEP/12
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