Ireland-based Covidien has received 510(k) approval from the US Food and Drug Administration for its HawkOne directional atherectomy system.


Featuring enhanced cutting mechanism, the system allows physicians to treat widest variety of plaque in patients with peripheral arterial disease (PAD).

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 firm’s directional atherectomy portfolio comprises TurboHawk and SilverHawk systems, which have been assessed by more than 15 peer-reviewed studies.

According to Covidien, PAD affects around 202 million people across the globe, while ten million people in the US.

When arteries in the legs become narrowed or blocked by plaque, PAD will be occurred. It results in severe pain, limited physical mobility and non-healing leg ulcers.

Covidien, which operates in around 150 countries, had reported revenue of $10.2bn in 2013.

Image: Covidien’s manufacturing facility in Galway, Ireland. Photo: courtesy of Covidien plc.