Cardiovascular Systems (NSDQ:CSII) said it enrolled 26 patients in the Japanese arm of a clinical trial for its "micro-crown" coronary orbital atherectomy device, 1 more than required by the study’s protocol.
CSII said it hopes to use the data from the trial, which is also slated to enroll at least 50 patients in the U.S., to back applications for market approval in both countries.
Enrollment in the U.S. arm of the trial is slated to be complete in 2015, according to a press release.
The 1.25mm micro-crown device is CSII’s 2nd-generation atherectomy system, designed to aid in stent placement in patients with severely calcified coronary lesions, the St. Paul., Minn.-based company said.
“Completing international enrollment is a key milestone in our path to expanding successful OAS treatment of patients with severe CAD," president & CEO David Martin said in prepared remarks. "Data from this study is expected to help secure approval for the use of the new micro-crown OAS in [coronary artery disease] patients in the world’s 2 largest coronary markets."