The company’s electric-driven Stealth 360°, and pneumatic-driven predecessor Diamondback 360°, Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.
The U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° in August 2007 and Stealth 360° in March 2011. The Stealth 360° has been rapidly adopted and is expected to accelerate the growth of orbital atherectomy in the future.
To date, over 100,000 of CSI’s devices have been sold to leading institutions across the United States. CSI has also commenced its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries.
The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.