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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
United States of America
Contact & Support

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.

View product brochure

        

Alert Indications, Safety, and Warnings

Getting results

Gain lumen and preserve patient’s native vessel.

Interventional cardiologist Jun Li, M.D., and interventional radiologist Mohammed Hoque, M.D., share the types of results they experience, and explain why they use HawkOne to treat all lesion morphologies.

Results are in the data.

DIRECT Trial: A randomized head-to-head trial comparing HawkOne to CSI Diamondback 360®* peripheral orbital atherectomy system. See the results.

View DIRECT Trial

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

View REALITY Study

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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, Drs. Mohammed Hoque and Jun Li discuss how to get started.

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

A click-in cutter drive and a quick-flush catheter make HawkOne simple to use. Drs. Jun Li and Mohammed Hoque found the learning curve to be quick 

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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.

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

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

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

1.4MB

Read article
Document thumbnail
pdf HawkOne directional atherectomy case book (.pdf)

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

2.7MB

Explore cases
Document thumbnail

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Product details

See the HawkOne device in action.

HawkOne 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 to preserve a patient's native vessel and keep future treatment options open.

Treat with procedural efficiency.

Select from 6 F and 7 F HawkOne devices. No capital equipment provides easy setup.

How to prepare the device

How to clean the device

Request wall chart

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More information

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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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