Cardiovascular Systems Enrolls First Patient in Liberty 360° Study
Post-Market Study of Peripheral Arterial Disease Evaluating Clinical and Economic Effectiveness of CSIs Orbital Atherectomy Technology Versus Other Treatment Options
ST. PAUL, Minn.--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSII) (CSI) (NASDAQ: CSII), 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 CSIs 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 studys principal investigator, performed the first procedure.
LIBERTY 360° is unique because its assessing success based on long-term outcomes and durability rather than acute angiographic results of the various treatments, said Dr. Staniloae. Moreover, our patient population includes complex cases, even those with advanced and severe PAD a subset that hasnt been studied before.
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 studys 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
David L. Martin, CSI president and chief executive officer commented, 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. CSI is an industry leader in clinical data support for our physician customers, and were dedicated to providing them with the information they need to make sound treatment decisions for their patients. LIBERTY 360° is the latest example of our commitment to this and were excited about the data and insight it will provide.
In the fall of 2012, data from another CSI PAD post market study, the CONFIRM series, demonstrated that the companys 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 CSIs orbital atherectomy system safely removes plaque in calcified lesions, with less than 1 percent perforations, about 2 percent distal embolization and vessel closure, and less than 6 percent bail-out stenting due to dissections preserving future treatment options. Results also demonstrated improved lesion compliance, with a low mean inflation of less than 6 atms for adjunctive balloon therapy. Safe and effective results, similar to those achieved in hospital settings, were also demonstrated in an office-based-lab setting.
About Peripheral Arterial Disease
As many as 8 million to 12 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Stealth 360° and Diamondback 360°, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The companys Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in August 2007. To date, nearly 110,000 of CSIs devices have been sold to leading institutions across the United States. CSI has also completed its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.
For more information, visit the companys website at www.csi360.com.
Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding (i) CSIs LIBERTY 360° trial, and (ii) CSIs potential coronary application, are forward-looking statements.
These statements involve risks and uncertainties which could cause results to differ materially from those projected, including but not limited to the effectiveness of the Stealth 360°; actual clinical trial results; FDA clearances and approvals and other factors detailed from time to time in CSIs SEC (SCUR) reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.
The Stealth 360°® PAD System, Diamondback 360® PAD System and Predator 360® PAD System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.
Cardiovascular Systems, Inc.
Investor Relations, 651-259-2800
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Padilla Speer Beardsley Inc.
Matt Sullivan, 612-455-1709
Dave Folkens, 612-455-1741
Source: Cardiovascular Systems, Inc.Copyright Business Wire 2013