FDA Clears Cardiovascular Systems' Orbital Atherectomy System

Cardiovascular Systems has received marketing clearance from the FDA for the company's Orbital Atherectomy System used to remove tissue causing stenosis in synthetic AV shunts.

The Orbital Atherectomy Device uses a diamond-coated, eccentrically rotating cutting surface to ablate tissue. Cardiovascular Systems believes the resulting particles are small enough to pass through capillaries and be eliminated by the body. The company expects to conduct initial market testing at a limited number of clinical sites before having a full commercial release of the product for treating AV shunts.

"The company is working on obtaining FDA clearance for use of the device in peripheral vascular disease, and approval for use in coronary arteries. In addition, the company is currently awaiting approval to commence a clinical trial in Europe to treat peripheral vascular disease," said Cardiovascular Systems CEO Michael Kallok.