Technology | November 05, 2014

Covidien’s HawkOne Directional Atherectomy System Receives FDA 510(K)

System strengthens the directional atherectomy platform with a versatile solution for the treatment of peripheral arterial disease

Nov. 5, 2014 — Food and Drug Administration gave 510(k) clearance for the HawkOne directional atherectomy system. The latest addition to Covidien’s directional atherectomy portfolio, the HawkOne system provides physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with peripheral arterial disease (PAD).

Covidien’s directional atherectomy portfolio includes the TurboHawk and SilverHawk systems and is backed by more than 15 peer-reviewed studies. Recent published data from Definitive LE Study in the Journal of American College of Cardiology, Cardiovascular Interventions demonstrated 95 percent limb salvage in patients with critical limb ischemia (CLI) and 78 percent overall patency in claudicant patients at 12 months following treatment with directional atherectomy.

For more information: www.covidien.com

Related Content

News | Peripheral Artery Disease (PAD) | November 14, 2019
November 7, 2019 — Ultrasoundplasty before angioplasty for below-the-knee lesions (BTK) lesions may improve clinical
News | Peripheral Artery Disease (PAD) | November 14, 2019
November 14, 2019 — There were positive results in the TANGO Trial is a phase 2, dose escalation, double-blinded tria
The LimFlow procedure permanently bypasses unreconstructable arteries and leverages healthier veins as a conduit to create new routes to perfuse tissue in the foot.  #VIVA #VIVA19 #VIVA2019

The LimFlow procedure permanently bypasses unreconstructable arteries and leverages healthier veins as a conduit to create new routes to perfuse tissue in the foot. 

News | Peripheral Artery Disease (PAD) | November 14, 2019
November 14, 2019 — Results were positive for the multicenter PROMISE I Trial represents the first human use in the U
Eluvia and Ranger PAD devices from Boston Scientific. #VIVA19 #VIVA2019 #VIVA
News | Peripheral Artery Disease (PAD) | November 06, 2019
November 6, 2019 – Boston Scientific announced positive data for two of its devices within the peripheral drug-elutin
FDA Panel Recommends Continued Use of Paclitaxel-coated Peripheral Devices
Feature | Peripheral Artery Disease (PAD) | August 28, 2019 | Jeff Zagoudis, Associate Editor
The U.S. Food and Drug Administration (FDA) released an updated MedWatch Alert this month on the safety of paclitaxel-...
New Report Says Concept Medical Positioned to Disrupt Peripheral Market
News | Peripheral Artery Disease (PAD) | August 27, 2019
Concept Medical was recently granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA)...
PAD Intervention Patients on Statins Less Likely to Face Amputation
News | Peripheral Artery Disease (PAD) | August 23, 2019
Patients with peripheral artery disease (PAD) were significantly less likely to face amputation after surgical...
Concept Medical Granted FDA Breakthrough Device Designation for MagicTouch PTA Sirolimus Coated Balloon
News | Peripheral Artery Disease (PAD) | August 14, 2019
Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug...
New AHA Statement Highlights Need for Early Diagnosis, Treatment With Critical Limb IschemiaCTA image of a patient with severe peripheral artery disease (PAD) viewed on a tablet device using Siemens syngo.via webviewer.

CTA image of a patient with severe peripheral artery disease (PAD) viewed on a tablet device using Siemens syngo.via webviewer. PAD can lead to CLI.

News | Peripheral Artery Disease (PAD) | August 13, 2019
Non-invasive techniques and devices for assessing blood flow and other diagnostic considerations for people with ...
Endovascular-first Approach Equal to Open Surgery in Avoiding Amputation for Critical Limb Ischemia
News | Peripheral Artery Disease (PAD) | August 01, 2019
Less-invasive procedures to open severely clogged leg arteries were as good at helping people survive and avoid...
Overlay Init