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Directional atherectomy systems

HawkOne™ directional atherectomy system

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

Ordering information
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Clinical trial results

The HawkOne™ system is supported by a substantial body of clinical evidence, including a systematic literature review and the DIRECT Trial — a randomized, head-to-head comparison of directional versus orbital atherectomy.

See clinical evidence

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 the HawkOne™ system to preserve a patient’s native vessel and keep future treatment options open.

Key benefits

  • 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

Specifications

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
This is an image of the HawkOne™ directional atherectomy system with numbered callouts.
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

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

The HawkOne™ directional atherectomy system optimized jog is shown with three numbered callouts.

Frequently asked questions

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The HawkOne™ directional atherectomy system is a device that removes plaque from the inside of peripheral arteries to gain lumen and preserve patient’s native vessel. Benefits also include consistent and predictable cutting, no capital equipment, and provides easy setup.

The HawkOne™ directional atherectomy system allows physicians to target eccentric and concentric plaque across all lesion morphologies — from soft to severely calcified in the peripheral vasculature. The HawkOne™ system can be used above and below the knee.

HawkOne™ devices are designed for vessels ranging from 2.0 mm to 7.0 mm in diameter.

The randomized DIRECT Trial6 demonstrated that lesions treated with the HawkOne™ directional atherectomy system had greater plaque volume reduction and luminal gain than those treated with the CSI Diamondback 360™* peripheral orbital atherectomy system.

The HawkOne™ directional atherectomy system is supported by a substantial amount of clinical evidence demonstrating its safety, effectiveness, and versatility in treating peripheral arterial disease (PAD). Key studies include:

 

  • REALITY Study shows how the use of the HawkOne™ system, followed by IN.PACT™ Admiral™ drug-coated balloon, even in complex, long, and heavily calcified lesions, can achieve long term results.
  • DIRECT Trial is a randomized, head-to-head comparison of directional versus orbital atherectomy.
  • Atherectomy Systematic Literature Review is an analysis of over 300 published studies, including 119 focused on directional atherectomy, confirming the high level of clinical rigor.
  • DEFINITIVE LE Study is the largest adjudicated atherectomy study highlighting HawkOne™ system’s clinical utility across diverse patient populations — including diabetics, claudicants, and those with critical limb-threatening ischemia.

 

View the clinical evidence

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

 

† 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.

 

Resources

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

  1. Data on file. HawkOne™ directional atherectomy system 6F tissue embolization and removal consistency, mass per mass, and cut depth report (RE-PV15259).
  2. HawkOne™ directional atherectomy system 7F bench performance verification testing, embolization (RE-PV13728). Bench testing may not be indicative of clinical performance.
  3. HawkOne™ directional atherectomy system 6F design validation cadaver report (10542060DOC). Non-clinical testing may not be indicative of clinical performance.
  4. HawkOne™ directional atherectomy system 7F design validation cadaver report (RE-PV13727). Non-clinical testing may not be indicative of clinical performance.
  5. Refer to IFU for instruction for treating severe calcium.
  6. Babaev A, Halista M, Bakirova Z, et al. Directional versus orbital atherectomy of femoropopliteal artery lesions: Angiographic and intravascular ultrasound outcomes. Catheter Cardiovasc Interv. 2022;100(4);687–695. doi:10.1002/ccd.30339.