The company has designed the study to evaluate the safety, efficacy and economic outcomes of its new micro crown Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions in patients with coronary artery disease (CAD).
CSI has enrolled 100 patients in the trial, which is being carrying out in the US and Japan.
The 1.25mm micro crown OAS system is said to facilitate stent delivery in patients with severely calcified lesions who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting.
The system has been developed to improve the tracking and piloting of the OAS driveshaft, as well as ability of the crown to reach the lesion while operating at lower rotational speeds.
CSI president and CEO David Martin said: "Data from this study will be key to secure approval for the use of the coronary micro crown OAS in the world’s two largest atherectomy markets."
In November 2014, the company completed enrollment of 26 patients at five sites in Japan, as well as enrolled 74 patients at 15 sites in the US.
