HawkOne Directional Atherectomy System

for atherectomy of peripheral vasculature

Treat above and below the knee with the HawkOne™ directional atherectomy system to restore blood flow by removing plaque in patients with peripheral arterial disease (PAD).

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HawkOne directional atherectomy system on white background
Alert Indications, Safety, and Warnings

Overview

See the HawkOne device in action.

The HawkOne device treats all plaque morphologies, including severe calcium. Quick and easy cleaning makes your procedure efficient. If your treatment goal is to make a small channel or to maximize luminal gain, choose HawkOne to preserve a patient's native vessel and keep future treatment options open.

Indications

The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

Risks may include but are not limited to: arterial perforation, embolism or arterial thrombosis, arterial dissection, arterial spasm, and vascular complications that could require surgical repair.

Product details

  • Consistent and predictable cutting1,2
  • Treats all lesion morphologies, from soft to severely calcified
  • Simplified directional atherectomy selection with 6 F and 7 F HawkOne devices
  • No capital equipment provides easy setup

HawkOne directional atherectomy system parts

  1. Cutter driver
    • Ergonomically redesigned and powered to effectively treat all morphologies
    • 12,000 RPMs
  2. Torquer knob
    • Directionally target eccentric and concentric plaque
  3. Drive shaft 
    • Designed to effectively transmit power
  4. Preloaded distal flush tool
    • Enables quick and easy cleaning
  5. Radiopaque distal tip
    • Provides enhanced visualization3,4 under angiography and ease of guidewire loading
    • Track to and treat distal lesions with the low-profile tip design
  6. Blade design
    • Four contoured cutting blades engage and treat all morphologies, even severe calcium5
HawkOne directional atherectomy system on transparent background with numbered callouts
HawkOne distal flush and cleaning tool on white background

Preloaded distal flush tool

Blade design of the drive shaft in the HawkOne directional atherectomy system

Drive shaft

Cutter blade design of the HawkOne directional atherectomy system

Cutter blade

Optimized jog

  • Allows for targeting and treatment of eccentric lesions
  • Enables wall opposition in 2–7 mm vessels
  1. Model H1-LS
  2. Model H1-M
  3. Distal tip
HawkOne optimized jog on white background with numbered callouts

Manuals and technical guides

Instructions for Use
Find this technical manual in the product labeling supplied with each device or by calling technical support for cardiovascular devices: 763-526-7890.

Model specifications

 

7 F

7 F

6 F

6 F

Model name

LS 

LX 

M 

S 

Catalog number

H1-LS

H1-LX

H1-M

H1-S

Vessel diameter (mm)

3.5–7.0

3.5–7.0

3.0–7.0

2.0–4.0

Sheath compatibility (Fr)

7

7

6

6

Crossing profile (mm)

2.6

2.6

2.2

2.2

Working length* (cm)

114

114

135

151

Effective length† (cm)

107

104

129

145

Tip length (cm)

6.6

9.6

5.9

5.9

Max. cut length (mm)

50

75

40

40

Packing device

X

X

X

X

*Working length — Distal end of preloaded flush tool, in the proximal position, to the distal end of tip.
†Effective length — Distal end of preloaded flush tool, in the proximal position, to the proximal end of cutter window.

Related pages

Peripheral catalog

Choose from a full portfolio of peripheral products for endovascular interventions — products that help you reach your PAD patient treatment goals.

Download catalog

Contact us.

CardioVascular Lifeline Customer Support

Orders

References

1

Data on file. HawkOne 6F Tissue Embolization and Removal Consistency, Mass Per Mass, and Cut Depth Report (RE-PV15259).

2

HawkOne 7F Bench Performance Verification Testing, Embolization (RE-PV13728).

3

HawkOne 6F Design Validation Cadaver Report (10542060DOC).

4

HawkOne 7F Design Validation Cadaver Report (RE-PV13727).

5

Refer to IFU for instruction for treating severe calcium.