Covidien’s HawkOne directional atherectomy system gets FDA 510(k) clearance to treat PAD

4 November 2014 (Last Updated November 4th, 2014 18:30)

Irish company Covidien has secured 510(k) approval from US Food and Drug Administration (FDA) for its HawkOne directional atherectomy system.

Irish company Covidien has secured 510(k) approval from US Food and Drug Administration (FDA) for its HawkOne directional atherectomy system.

The new system features an improved cutting mechanism, allowing physicians to treat a wide range of plaque in patients with peripheral arterial disease (PAD).

The disease affects more than 202 million people worldwide and more than ten million people in the US.

PAD occurs when arteries in the legs become narrowed or blocked by plaque, and it can result in severe pain, limited physical mobility and non-healing leg ulcers.

"The new system features an improved cutting mechanism, allowing physicians to treat a wide range of plaque in patients with peripheral arterial disease (PAD)."

The disease can also lead to serious health consequences such as amputation, cardiovascular disease and death.

Covidien peripheral vascular president Brian Verrier said: "Covidien is committed to being the clear first choice for our physician and hospital partners by delivering new innovative technologies that help save and improve patient lives.

"The FDA clearance of the HawkOne system enhances our leading peripheral vascular portfolio and further demonstrates Covidien's leadership in the atherectomy space."

The company's directional atherectomy portfolio comprises of TurboHawk and SilverHawk systems, which were evaluated by more than 15 peer-reviewed trials.

Recent published data from the DEFINITIVE LE trial showed 95% limb salvage in patients with critical limb ischemia (CLI) and 78% overall patency in claudicant patients at 12 months following treatment with directional atherectomy.

Covidien has more than 38,000 employees and operates in 150 countries with a reported revenue of $10.2bn in 2013.