CSI Announces Recommendation for ISO Certification

Cardiovascular Systems announced it received recommendation for ISO 13485:2003 registration of its quality management system.

The recommendation represents an important step toward receiving authorization to affix the CE Mark of conformity, allowing European commercialization. The Orbital Atherectomy Device utilizes a diamond-coated, eccentrically rotating cutting surface to ablate tissue. The company believes the resulting particles are small enough to pass through capillaries and be eliminated by the body. The company is working to obtain FDA clearance for use of the device in peripheral vascular disease, and approval for use in coronary arteries.

The company previously announced it received marketing clearance from the FDA for the Orbital Atherectomy System to remove tissue causing stenosis in synthetic AV shunts. 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.