Cardiovascular Systems Enrolls First Patient in LIBERTY 360° Postmarket Study

May 30, 2013—Cardiovascular Systems, Inc. (CSI; St. Paul, MN), announced that the first patient has been enrolled in its postmarket 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.

“LIBERTY 360° is unique because it's assessing success based on long-term outcomes and durability, rather than acute angiographic results of the various treatments,” said Cezar Staniloae, MD. Dr. Staniloae is the study's Principal Investigator and is with NYU Medical Center and New York Cardiovascular Associates in New York, New York. “Moreover, our patient population includes complex cases, even those with advanced and severe PAD—a subset that hasn't been studied before,” added Dr. Staniloae.

LIBERTY 360° is a prospective, observational, multicenter postmarket study. It will enroll up to 1,200 patients at 100 sites across the United States, including 500 patients with claudication; 500 who have critical limb ischemia (CLI); 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.

William Gray, MD, of Columbia University Medical Center in New York, New York, is National Principal Investigator of the claudicant arm of the study (Rutherford 2–3). For the CLI arm (Rutherford 4–5), the National Principal Investigators are Gary Ansel, MD, of Riverside Methodist Hospital in Columbus, Ohio, and George Adams, MD, of Rex Healthcare in Raleigh, North Carolina. Jihad Mustapha, MD, of Metro Health Hospital in Grand Rapids, Michigan, is National Principal Investigator of the CLI arm (Rutherford 6).

In the fall of 2012, data from another CSI PAD postmarket study, the CONFIRM series, demonstrated that the company's minimally invasive orbital atherectomy system is a safe and effective treatment for PAD. CONFIRM explored outcomes in more than 3,000 patients and 4,700 lesions in a real-world setting, and showed that CSI's orbital atherectomy system safely removes plaque in calcified lesions, with < 1% perforations, approximately 2% distal embolization and vessel closure, and < 6% bailout stenting due to dissections, preserving future treatment options. Results also demonstrated improved lesion compliance, with a low mean inflation of < 6 atm for adjunctive balloon therapy. Safe and effective results, similar to those achieved in hospital settings, were also demonstrated in an office-based lab setting.