LIBERTY 360° Study 12-Month Data Demonstrate Lasting Benefits Following Endovascular Intervention in Patients with Critical Limb Ischemia (CLI)

08/10/2017
  • Landmark 1,200 patient study 12-month clinical data shared at Amputation Prevention Symposium
  • Patients across all Rutherford Classes show high Freedom from Major Amputation and Major Adverse Events (MAE)
  • CLI patients show improvement in Rutherford Classification (RC), Wound Healing and Quality of Life

ST. PAUL, Minn.--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII) today released one-year data from its LIBERTY 360° clinical study in a late-breaking presentation at the 2017 Amputation Prevention Symposium (AMP) in Chicago.

The LIBERTY 360° study is 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 1,200 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 (RC 2-6). As an “all comers” study, LIBERTY 360°’s novel trial design included any endovascular device FDA-approved for treatment of PAD.

One-year study outcomes were presented at AMP by Dr. Jihad Mustapha, Director of Cardiac Research at Metro Health Hospital, University of Michigan Health, Wyoming, Michigan. Dr. Mustapha’s presentation highlighted results in the most severe form of PAD, called critical limb ischemia (CLI), that spans RC 4-6 and where amputation prevention should be the primary goal in treating these patients. 12-month data* from LIBERTY 360° showed 96% freedom from amputation in RC 4-5 (N=589) and 81.7% in RC 6 (N=100). In addition, CLI patients in the study showed notable improvements in Rutherford Classification, Wound Healing, and Quality of Life out to 12 months.

Said Dr. Mustapha, “LIBERTY 360 represents as close to a real-world experience as possible with various endovascular strategies across Rutherford Classes. Following endovascular intervention, we saw a marked improvement across all Rutherford Classes at one year, as well as high freedom from major adverse events. In particular, LIBERTY 360 provides new, compelling evidence that PVI can lead to amputation free survival in CLI patients and serves as a patient-centric alternative to primary amputation.”

In his presentation, Dr. Mustapha also noted that the LIBERTY 360 clinical outcomes for CLI patients appear to support a new Class I guideline in the recently revised 2016 AHA/ACC Guidelines on the Management of Patients with PAD which states that “an evaluation for revascularization options should be performed by an interdisciplinary care team before amputation in the patient with CLI.”

Said Scott Ward, CSI’s Chairman, President and Chief Executive Officer, “Our commitment to clinical rigor is key to our success and growth plans. The LIBERTY 360 study continues to reinforce the importance of endovascular intervention for this difficult-to-treat patient population, with a particular focus on amputation prevention for patients with PAD, and specifically critical limb ischemia.”

Specific detail from the one-year LIBERTY 360° study data can be found at www.csi360.com.

* Kaplan-Meier method used to estimate event-free rates and major amputation of target limb. MAE defined as death (≤30 days after index procedure), major amputation of the target limb, and TVR.

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 Orbital Atherectomy Systems 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 the first 510(k) clearance for the use of the Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the Coronary Orbital Atherectomy System. To date, over 324,000 of CSI’s devices have been sold to leading institutions across the United States. For more information, visit the company’s website at www.csi360.com.

Safe Harbor
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, 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, 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.

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.

Literature shows that Balloon angioplasty and stents can 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. Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Diamondback 360® and Stealth 360® Peripheral Orbital Atherectomy Systems, which are 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.

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 (RC 2-3), 603 patients with critical limb ischemia (CLI; RC 4-5) and 100 patients with the most severe form of CLI (RC 6). The study included any endovascular device FDA-approved 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.

Source: Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc.

Mark Sullivan, 651-900-7077

msullivan@csi360.com

or

Padilla

Matt Sullivan, 612-455-1709

matt.sullivan@padillaco.com