The approval enhances the company's peripheral vascular portfolio.
Covidien has announced US Food and Drug Administration 510(k) clearance for the HawkOne directional atherectomy system. The latest addition to its directional atherectomy portfolio, the system provides physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with peripheral arterial disease (PAD).
The FDA approval of the system enhances the company's leading peripheral vascular portfolio.
"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 HawkOnesystem enhances our leading peripheral vascular portfolio and further demonstrates Covidien's leadership in the atherectomy space," said Mr Brian Verrier, president, peripheral vascular, Covidien.