LIBERTY 360° Study 12-Month Sub-Analysis Reveals High Freedom from Major Amputation and Major Adverse Events (MAE) Using Cardiovascular Systems’ Diamondback 360® Peripheral Orbital Atherectomy System (OAS)

  • OAS utilization resulted in high Freedom from Major Amputation at one year across all Rutherford Classes (RC 2-3, 100%; RC 4-5, 95.8%; and RC 6, 91.2%)
  • OAS prior to DCB therapy resulted in high Freedom from MAE at one year (95.2%) with no major amputations

ST. PAUL, Minn.--()--A new sub-analysis from the landmark LIBERTY 360° study, sponsored by Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), was presented today as part of a late-breaking presentation at the 2017 Amputation Prevention Symposium (AMP) in Chicago.

“These findings show that patients treated with our innovative orbital atherectomy device experienced positive clinical outcomes such as high freedom from major adverse events and freedom from major amputation,“ said Scott Ward, CSI’s Chairman, President and Chief Executive Officer.”

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 symptomatic lower extremity peripheral artery disease (PAD). Physicians were able to use any FDA-approved device, including CSI’s Diamondback 360® Peripheral OAS, which was the most frequently used atherectomy device in the study.

The sub-analysis, highlighting 12-month Freedom from Major Adverse Events and Major Amputation, supports the value of CSI’s Diamondback 360® Peripheral OAS during endovascular intervention for Rutherford Class 2-6 patients (N=493):

  • Sub-analysis: Diamondback 360® Peripheral OAS Freedom from Major Adverse Events—In a post hoc analysis, patients treated with OAS, as part of their PVI showed high freedom from MAE in all groups with statistically similar MAE outcomes at 12 months in RC 4-5 and RC 6, as well as high freedom from major amputation in all Rutherford Classes (RC 2-3, 100%; RC 4-5, 95.8%; and RC 6, 91.2%).
 
Table 1: Orbital Atherectomy (OAS) 12-Month Freedom from (FF) Major Adverse Events (MAE)
    Rutherford Classification
    RC 2-3   RC 4-5   RC 6
    N=211   N=226   N=56
FF MAE (1-year)   87.0%   75.9%   71.2%
FF Major Amputation   100%   95.8%   91.2%
FF Target Vessel Revascularization (TVR)   87.9%   78.9%   78.2%
FF Death (inclusive of all deaths after 30-days)   97.1%   91.1%   82.9%
     

Table 1: High freedom from MAEs at 12 months in patients treated with OAS across all Rutherford Classes. Kaplan-Meier method used to estimate event-free rates. MAE defined as death (≤30 days after index procedure), major amputation of the target limb, and TVR.

In addition, patients receiving vessel prep with OAS prior to drug-coated balloon (DCB) therapy resulted in high freedom from MAE (95.2%; N=21) at 12 months with no major amputations reported.

"These findings show that patients treated with our innovative orbital atherectomy device experienced positive clinical outcomes such as high freedom from major adverse events and freedom from major amputation,“ said Scott Ward, CSI’s Chairman, President and Chief Executive Officer. "It further validates OAS as an effective treatment option for patients suffering from severe forms of PAD."

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

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 (Rutherford 2-3), 603 patients with critical limb ischemia (CLI; Rutherford 4-5) and 100 patients with the most severe form of CLI (Rutherford 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.

Product Disclosure
The Diamondback 360® and Stealth 360® PAD Systems 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.

Contacts

Cardiovascular Systems, Inc.
Mark Sullivan, 651-900-7077
msullivan@csi360.com
or
Padilla
Matt Sullivan, 612-455-1709
matt.sullivan@padillaco.com

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