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Indications, Safety, & Warnings

Indications, Safety, and Warnings
HawkOne Directional Atherectomy System

Note: Safety information provided is for the United States. Please refer to your region’s Instructions for Use for specific details.

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at 763-514-4000 (worldwide). Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.

Reference statement

Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: 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.

Potential Adverse Effects of the Device on Health: The potential complications include, but are not limited to, amputation, aneurysm, arterial dissection, arterial perforation, arterial rupture, arterial spasm, arteriovenous fistula, bleeding complications, death, embolism or arterial thrombosis, emergency or non-emergency arterial bypass surgery, entry site complications, hypotension, infection, ischemia, restenosis of the treated segment, total occlusion of the peripheral artery, or vascular complications that could require surgical repair.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

FTSOP113326-55 Rev. 1B

UC201712496-01a EN

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United States of America
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HawkOne™ directional atherectomy system

Know what
they know.

Physicians share their experience, techniques, and advice for using the HawkOne™ directional atherectomy system to treat peripheral arterial disease.

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Alert Indications, Safety, and Warnings

Getting results

Gain lumen and preserve patient’s native vessel.

Physicians share the reasons they choose to use HawkOne™ directional atherectomy system to treat all lesion morphologies and the types of results they experience.

Results are in the data.

DIRECT Trial: A randomized head-to-head trial comparing HawkOne™ directional atherectomy system to Abbott Diamondback 360®* peripheral orbital atherectomy system

View DIRECT Trial

REALITY Study: Demonstrates the use of HawkOne™ directional atherectomy system followed by IN.PACT™ Admiral™ drug-coated balloon

View REALITY Study

Atherectomy systematic literature review and meta-analysis: Evaluated the amount and rigor of published data on atherectomy

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Getting started

HawkOne™ directional atherectomy system.

Click.
Flush.
Go.

Request a demo

If you haven’t tried directional atherectomy or HawkOne™ directional atherectomy system yet, watch this video to hear from our panel of physicians about why they tried it and how they got started using this device.

Watch this video to get tips from Dr. Jun Li on how she achieves a 360-degree cut.
 

How does HawkOne™ directional atherectomy system compare to other atherectomy devices for usability and impact procedural times? Hit play to find out.

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Technique and case studies

Sharing best practices, techniques, and knowledge with peers is how we all learn and grow our skills. Below, physicians share their algorithms to treat calcified lesions with HawkOne™ directional atherectomy system.

Isolated SFA stenosis
 

Treating CLTI
 

Focal SFA and proximal popliteal occlusion

Short segment, high-grade stenosis
 

Below the knee: occlusion of the distal anterior tibial artery

Short segment CTO in the region of the common femoral artery

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pdf Cath Lab Digest: Using Directional Atherectomy for the Revascularization of CTO in CLI (.pdf) (opens new window)

Dr. James Foster shares his strategy for using HawkOne™ directional atherectomy system for the revascularization of chronic total occlusions in critical limb ischemia.

1.4MB

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pdf HawkOne™ Directional Atherectomy Case Book (.pdf) (opens new window)

Explore cases that demonstrate the versatility the HawkOne™ directional atherectomy system platform offers to treat above and below the knee.

2.7MB

Explore cases(opens new window)
Document thumbnail (opens new window)
pdf Cath Lab Digest: The HawkOne™ Directional Atherectomy System Puts Control in the Hands of the Operator (.pdf) (opens new window)

Drs. Michael Paisely and Brant Ullery discuss their endo-first approach and share two cases.

1.1MB

Learn more(opens new window)
Document thumbnail (opens new window)

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Product details

See the HawkOne™ directional atherectomy device in action.

HawkOne™ directional atherectomy system effectively treats all lesion morphologies, from soft to severely calcified. 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™ directional atherectomy system to preserve a patient’s native vessel and keep future treatment options open.

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Treat with procedural efficiency.

Select from 6 F and 7 F HawkOne™ directional atherectomy system devices. No capital equipment provides easy setup.

How to prepare the device

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How to clean the device

Request wall chart

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More information

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

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United States

Customer Care Team

Hours: 8:00 a.m. - 8:00 p.m. EST 

 

Phone: 763-514-4000

Toll-free: 800-633-8766

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