CSI Announces CE Mark for Its Orbital Atherectomy System

Cardiovascular Systems (CSI) has received the CE mark for European Union (EU) commercialization for its Orbital Atherectomy System (OAS) used in the treatment of peripheral artery disease.

The OAS utilizes a diamond-coated, eccentrically rotating cutting surface to ablate tissue. CSI believes the resulting particles are small enough to pass through capillaries and be eliminated by the body.

The EU approval represents an important milestone for CSI as it works toward full worldwide commercialization of the OAS. The company has previously announced it had received marketing clearance from the FDA for the OAS 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.