Nov. 6, 2014 — Cardiovascular Systems Inc. received the CE Mark 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).
Stealth 360º will be available in Europe with a 0.014 in guide wire platform, and crown sizes of 1.25 mm, 1.50 mm, 1.75 mm and 2.00 mm.
The system includes the following features: Orbital Atherectomy Device, Saline Pump, Atherectomy guide wire and Atherectomy lubricant
The U.S. 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. To date, nearly 170,000 of CSI’s devices have been sold to leading institutions across the United States.
For more information: www.csi360.com