Cardiovascular Systems Receives CE Mark for Stealth 360 Orbital Atherectomy System

Cardiovascular Systems Inc. (CSI) has received CE Mark approval for its Stealth 360º Orbital Atherectomy System (OAS). Stealth 360º is a percutaneous OAS designed to treat patients suffering from peripheral arterial disease (PAD).

“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/CEO. “A determining factor for CLI is calcium buildup in leg arteries, particularly small vessels below the knee. Our technology has demonstrated it can safely and effectively treat this complex disease, with lasting results.”

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. 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.

Stealth 360º is available in Europe with a 0.014-inch guidewire platform, and crown sizes of 1.25 millimeters, 1.50millimeters, 1.75 millimeters and 2 millimeters. The system consists of the Orbital Atherectomy Device, Saline Pump, Atherectomy guide wire and Atherectomy lubricant—all of which received CE Mark.

In Europe and North America, an estimated 27 million individuals are affected with PAD, which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.

CSI’s treatment for peripheral arterial disease feature systems that use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue — a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions, according to CSI. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.

Based in St. Paul, Minn., Cardiovascular Systems develops and commercializes vascular and coronary disease treatments. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart; the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries.