Minnesota-based Cardiovascular Systems (NSDQ:CSII) enrolled the 1st patient in its new COAST clinical trial, examining outcomes in patients treated with the company’s micro crown Orbital Atherectomy System.
The 2nd-generation device helps surgeons treat severely calcified coronary lesions in patients with difficult-to-treat cases of coronary artery disease, helping to deliver stents to the affected blood areas.
The new study is a single-arm trial enrolling up to 100 patients at up to 15 sites in the U.S. and 5 sites in Japan, according to a press release.
"We’re eager to launch our first international coronary study which will support the approval of our next-generation system in the United States and Japan," CSI president & CEO David Martin said in prepared remarks. "COAST aligns with our ORBIT II data protocol and study details – giving CSI a further opportunity to build on the compelling results we delivered in ORBIT II. Additionally, it will highlight the potential benefits of our new micro crown and, we hope help secure commercial approval in Japan."
The 1st COAST patient was enrolled at North Florida Regional Medical Center, Gainesville, Fla., according to the company.