Covidien`s HawkOne Directional Atherectomy System Receives FDA 510(k) Clearance for Treatment of PAD

The HawkOne System strengthens Covidien’s directional atherectomy platform with a versatile solution for the treatment of peripheral arterial disease
 
DUBLIN, Ireland -- October 4, 2014 - Covidien plc today announced U.S. Food and Drug Administration 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 the 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 (the ability for the treated artery to remain open) in claudicant patients at 12 months following treatment with directional atherectomy.[i]
 
About Covidien
Covidien is a global health care leader that understands the challenges faced by providers and their patients and works to address them with innovative medical technology solutions and patient care products. Inspired by patients and caregivers, Covidien’s team of dedicated professionals is privileged to help save and improve lives around the world. With more than 38,000 employees, Covidien operates in 150-plus countries and had 2013 revenue of $10.2 billion. To learn more about our business visit www.covidien.com or connect with us on Twitter.

[i] McKinsey J, Zeller T, Rocha-Singh K, Jaff M, Garcia L, DEFINITIVE LE Investigators. Lower Extremity Revascularization Using Directional Atherectomy: 12-Month Prospective Results of the DEFINITIVE LE Study. JACC: Cardiovascular Interventions 2014; 7(8):923-33.