The company said Liberty 360° will enroll up to 1,200 patients, 500 with painful circulatory problems, 500 with severe PAD and 200 slated for amputation. The trial is designed to measure long-term outcomes including quality of life, economic costs and more typical PAD medical outcomes.
"Past studies have proven that treating PAD patients with our orbital atherectomy system is safe and effective. The Liberty 360° study is a massive undertaking looking at a large number of the most difficult-to-treat patients," CEO David Martin said in a statement.
PAD is caused by accumulation of plaque in peripheral arteries, usually in the limbs. CSII’s treatments, called Stealth 360° and Diamondback 360°, use a diamond-coated crown to sand away plaque.
The St. Paul, Minn.-based medical device company recently priced a public offering of some 2 million shares $17.60 apiece, and will likely use much of the expected $33 million on expenses for the Orbit II clinical trial of its atherectomy device.