Medtronic has received CE mark approval for its HawkOne directional atherectomy system in a lower profile size to treat patients with peripheral artery disease (PAD).
The system will be used to remove plaque from the vessel wall and restore blood flow. It will allow physicians to effectively treat severe calcified lesions with no increase in cut depth.
It features a preloaded flush tool that improves cleaning time, while the 6F size will simplify device selection and provide easy set-up with no capital equipment.
According to the company, the PAD is a serious and chronic condition that affects more than 200 million people across the globe.
The company also produces TurboHawk and SilverHawk(TM) systems, which are part of directional atherectomy portfolio.
Medtronic aortic and peripheral vascular division’s peripheral business general manager and vice president Mark Pacyna said: "We are excited to announce CE Mark approval for HawkOne 6F shortly after receiving FDA clearance for the system in October.
"The HawkOne 6F system provides physicians with an effective and efficient treatment option for treating PAD above and below the knee and reinforces our commitment to expand access to therapy innovations that protect limbs and enhance lives."