Directional atherectomy systems

HawkOne™ directional atherectomy system

HawkOne™ directional atherectomy systemHawkOne™ directional atherectomy system

Directional atherectomy systems

HawkOne™ directional atherectomy system

Treat above and below the knee with the HawkOne™ directional atherectomy system to remove plaque in patients with peripheral arterial disease (PAD).

Ordering information
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Indications, Safety, and Warnings

Description

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.

Overview

Clinical evidence

The DIRECT Trial, a randomized head-to-head trial comparing HawkOne to CSI Diamondback 360™* peripheral orbital atherectomy system.

See the results

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.

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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
The HawkOne™ system includes a cutter driver (1), torquer knob (2), and distal flush tool (3).
The HawkOne distal flush tool enables quick and easy cleaning.

Preloaded distal flush tool

This is an image showing the blade design of the drive shaft in the HawkOne directional atherectomy system.

Drive shaft

This is an image showing the cutter blade design of the HawkOne directional atherectomy system.

Cutter blade

Improves engagement in calcified lesions and enhances wall opposition in vessels 2 to 7 mm.

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

Ordering information

  7 F 7 F 6 F 6 F
Model name LS LX M S
Item 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

Resources

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™* Third-party brands are trademarks of their respective owners.

† 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.

  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.