Cardiovascular Systems Enrolls First Patient in Liberty 360° Study

Cardiovascular Systems, Inc. (CSI)

, announced that the first patient has been enrolled in its post-market study, LIBERTY 360°. The study is evaluating the acute and long-term clinical and economic outcomes of CSI's orbital atherectomy system in treating peripheral arterial disease (PAD). Additionally, LIBERTY 360° is the first study of its kind to compare orbital atherectomy to all other PAD treatment options in a difficult-to-treat patient population. Dr. Cezar Staniloae, NYU Medical Center / New York Cardiovascular Associates, N.Y., the study's principal investigator, performed the first procedure. LIBERTY 360° is a prospective, observational, multi-center post-market study. It will enroll up to 1,200 patients at 100 sites across the United States, including 500 patients with claudication (painful circulatory problems), 500 who suffer from critical limb ischemia (CLI) (a severe form of PAD), and 200 scheduled for amputation. LIBERTY 360° is the first study of its kind to specifically include this challenging population and will evaluate numerous parameters including procedural and lesion success, rate of major adverse events, duplex ultrasound findings, quality of life, six-minute walk test, wound status, economic outcomes, and development of plaque burden assessment. The study's national principal investigators are: * Claudicant Arm (Rutherford 2-3): Dr. William Gray, Columbia University Medical Center, New York, NY * CLI Arm (Rutherford 4-5): Dr. Gary Ansel, Riverside Methodist Hospital, Columbus, OH, and Dr. George Adams, Rex Healthcare, Raleigh, NC * CLI Arm (Rutherford 6): Dr. Jihad Mustapha, Metro Health Hospital, Grand Rapids, MI