Stealth 360 OAS Receives CE Mark to Treat Peripheral Arterial Disease

Devicemaker Cardiovascular Systems said it has received a European CE mark for its Stealth 360 percutaneous Orbital Atherectomy System, indicated to treat patients who suffer from peripheral arterial disease. The device has been available in the U.S. since 2007, when it received 510(k) clearance.

The system consists of four main components: (1) an orbital atherectomy device, (2) saline pump, (3) atherectomy guide wire and (4) atherectomy lubricant — all of which received the CE mark, CSI said. The Stealth 360 will be available in a 0.014in guide wire platform with crown sizes of 1.25mm, 1.50mm, 1.75mm and 2mm, the St. Paul, Minn., devicemaker said this week.

CSI president David Martin said securing the mark is an important milestone toward helping patients in Europe suffering from PAD, especially those with critical limb ischemia, who have been underserved by other treatment options. The technology’s unique mechanism of action demonstrated it can safely and effectively treat the complex disease with lasting results, he added.

27 million individuals are affected with PAD in Europe and North America, CSI said. It is caused by the accumulation of plaque in peripheral arteries — commonly the pelvis or leg — reducing blood flow. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. Because risk factors like diabetes and obesity are rising, so too is the prevalence of PAD, CSI said. — Kellen Owings

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