ST. PAUL, Minn.--(BUSINESS WIRE)--
Company introduces Diamondback 360° Exchangeable Series to treat multi-level PAD
Cardiovascular Systems, Inc. (CSI®) (CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the three-year outcomes from its LIBERTY 360° study will be featured in a late-breaking presentation at the 2019 Amputation Prevention Symposium (AMP) in Chicago on Friday, August 16th. In addition, the two-year endovascular PAD-related health care costs in LIBERTY 360° and an orbital atherectomy economic sub-analysis will also be presented on Thursday, August 15th.
LIBERTY 360° is a real-world, one-of-a-kind study designed to evaluate the acute and long-term clinical and economic outcomes of peripheral vascular interventions (PVI) in patients with peripheral artery disease (PAD). With over 1,204 patients enrolled at 51 sites across the United States, it is among the first PAD studies to investigate patients across the spectrum of symptomatic PAD, including an unprecedented 100 Rutherford Class 6 patients, who are more difficult to study. As an “all comers” study, LIBERTY 360°’s novel trial design included any endovascular device FDA-cleared for treatment of PAD.
Late-Breaking Presentation: LIBERTY 360° Three-Year Data
Jihad A. Mustapha, MD, FACC, FSCAI
Advanced Cardiac & Vascular Amputation Prevention Centers Grand Rapids, Michigan
Friday, August 16, 3:31 p.m.
“The LIBERTY 360° study differentiates CSI’s clinical data from all competitors and underscores our commitment to studying and serving patients suffering from PAD,” Scott Ward, CSI’s Chairman, President and Chief Executive Officer. “Our responsibility to these patients extends to introducing innovative tools to help physicians treat patients suffering from multi-level PAD. This week we will initiate sales for a full market launch of our Diamondback Exchangeable Series – the most advanced orbital atherectomy system designed for optimal, complete leg revascularization of PAD patients with lesions above and below the knee.
“We estimate that up to 50% of PAD patients suffer from multi-level disease. The Exchangeable Series adds several new features to cost-effectively treat these complex patients, including GlideAssist and the ability to use multiple crown sizes with a single handle during an orbital atherectomy procedure to treat significantly different-sized arteries. We believe the Exchangeable Series will become an important tool for physicians treating patients with multi-level PAD.”
About Peripheral Artery Disease (PAD)
As many as 18 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries 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® Peripheral Orbital Atherectomy Systems, 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 company’s OAS treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart 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 peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. The Stealth 360® Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. In March 2017, the company received PMDA approval in Japan for the Diamondback 360® Coronary OAS Micro Crown and reimbursement approval effective February 2018. Over 470,000 of CSI’s devices have been sold to leading institutions worldwide. For more information, visit the company’s website at www.csi360.com.
About LIBERTY 360°
LIBERTY 360° is a prospective, observational, multi-center post-market study that enrolled over 1,200 patients at 51 sites across the United States, including 501 patients with claudication (RC2-3), 603 patients with critical limb ischemia (CLI; RC4-5) and 100 patients with the most severe form of CLI (Rutherford 6). The study included any endovascular device FDA-cleared for treatment of PAD. Enrollment was completed in February 2016 and patients will be followed for up to five years.
LIBERTY 360° is among the first PAD studies to investigate patients across the spectrum of symptomatic PAD and will assess numerous parameters including procedural success, rate of major adverse events, duplex ultrasound findings, quality of life, six-minute walk test, wound status, and economic outcomes.
More information about the study design is available at www.ClinicalTrials.gov; identifier: NCT01855412.
The Stealth 360® PAD System and Diamondback 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.
Caution: Federal law (USA) restricts this device to sale by, or on the order of, a physician.
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 the LIBERTY 360° study, including the expected evidence and outcomes from the study, and the Exchangeable Series, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, actual study results; the reluctance of physicians to accept new products; the effectiveness of the Exchangeable Series; the impact of competitive products and pricing; reimbursement for the products CSI sells; and other factors detailed from time to time in CSI’s SEC 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.