CE Mark for Cardiovascular Systems’ Stealth 360® Peripheral Orbital Atherectomy System

Cardiovascular Systems, Inc. has gained CE Mark approval for its Stealth 360º Orbital Atherectomy System (OAS). Stealth 360º is a percutaneous OAS that is indicated to treat patients who suffer from peripheral arterial disease (PAD).


PAD is a common circulatory disease in which plaque deposits build up on the walls of blood vessels, reducing blood flow. In Europe and North America, an estimated 27 million individuals are affected with PAD. Critical Limb Ischemia (CLI) is a chronic, severe form of PAD that affects approximately 2.7 million people in North America and 3.3 million in Western Europe. Plaque ranges from soft to calcified. Calcified and fibrotic deposits are the most difficult to treat with traditional interventional procedures and are more common in older patients. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.

Cardiovascular Systems is a developer of Orbital Atherectomy Systems to treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time. The company says its devices address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.

One such device, the new Stealth 360º will now 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 consists of the following main components: Orbital Atherectomy Device, Saline Pump, Atherectomy guide wire and Atherectomy lubricant—all of which now carry the CE Mark.

Company comments

“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,” said David L. Martin, CSI president and chief executive officer. “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.”

“We are excited to be able to offer our OAS technology as a solution to millions of PAD sufferers outside of the United States and are currently evaluating the timing and structure of our plans to commercialize our products in Europe.”

Source: Cardiovascular Systems, Inc., Business Wire

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