US-based medical device company Cardiovascular Systems (CSI) has obtained CE mark approval for its Stealth 360º Orbital Atherectomy System (OAS).
Stealth 360º is a percutaneous OAS developed to treat patients who suffer from peripheral arterial disease (PAD).
CSI president and CEO David Martin said: "Securing CE Mark for Stealth 360º greatly expands our market opportunity and is an important milestone toward benefiting patients in Europe suffering from PAD — especially those with critical limb ischemia, (CLI) who have been underserved by other treatment options.
"A determining factor for CLI is calcium buildup in leg arteries, particularly small vessels below the knee. Our technology, with its unique mechanism of action, has demonstrated it can safely and effectively treat this complex disease, with lasting results."
Stealth 360º is said to be available in Europe with a 0.014 guide wire platform, and crown sizes of 1.25mm, 1.50mm, 1.75mm and 2.00mm.
The system includes components such as Orbital Atherectomy Device, Saline Pump, Atherectomy guide wire and Atherectomy lubricant.
CSI develops and markets products to treat vascular and coronary disease.