US-based medical device firm Cardiovascular Systems (CSI) has received CE Mark for its Stealth 360º Orbital Atherectomy System (OAS), which is indicated to treat patients who suffer from peripheral arterial disease (PAD), a common circulatory disease.
In PAD, plaque deposits build up on the walls of blood vessels, reducing blood flow.
The company said that Stealth 360º will be available in Europe with a 0.014in guide wire platform, and crown sizes of 1.25mm, 1.50mm, 1.75mm and 2mm.
The system’s main components include orbital atherectomy device, saline pump, atherectomy guide wire and atherectomy lubricant.
CSI president 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, demonstrated it can safely and effectively treat this complex disease, with lasting results.
"We are excited to be able to offer our OAS technology as a solution to millions of PAD sufferers outside of the US and are currently evaluating the timing and structure of our plans to commercialize our products in Europe."
On average, 27 million individuals suffer from PAD in Europe and North America, and CLI a chronic, severe form of PAD affects 2.7 million people in North America and 3.3 million in Western Europe.
The company is focused on developing and commercialising new solutions for treating vascular and coronary disease.