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Landmark Study From Cardiovascular Systems Demonstrates Sustained Benefit Of Endovascular Intervention In Patients With Lower Extremity Peripheral Artery Disease

Published: Feb 07, 2017

ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems (CSI) (NASDAQ: CSII) presented six-month data from its LIBERTY 360° post-market study in a presentation at the 29th International Symposium on Endovascular Therapy (ISET) in Hollywood, Florida. The study is evaluating the acute and long-term clinical and economic outcomes of peripheral vascular interventions (PVI) in treating patients with symptomatic lower extremity peripheral artery disease (PAD). Physicians were able to use any FDA approved device, including CSI’s Diamondback 360® peripheral orbital atherectomy system. Findings continue to demonstrate that PVI can be successful in treating patients in all Rutherford Classes and suggest that “watchful waiting” for patients in Rutherford Class 2-3 and “primary amputation” for patients in Rutherford Class 6 may not be necessary.

“We’re encouraged by the six-month results from LIBERTY 360° and the implications for patients suffering from severe forms of PAD. We look forward to releasing one-year results later this year.”

Six-month study outcomes were presented at ISET on Monday, Feb. 6 by Dr. William Gray of Main Line Health, Wynnewood, Pennsylvania. Additional authors on the abstract included Dr. Jihad Mustapha of Metro Health Hospital, Wyoming, Michigan; Dr. George L. Adams of Rex Healthcare, Raleigh, North Carolina; Dr. Gary Ansel of OhioHealth in Columbus, Ohio; and Dr. Michael Jaff, President, Newton-Wellesley Hospital and Professor of Medicine, Harvard Medical School, Newton, Massachusetts.

Key Six-Month Analysis Conclusions

  • Findings suggest that on average PVI can restore Rutherford 4-5 patients with critical limb ischemia (CLI) status (e.g. limb pain at rest, cold and/or numbness in feet, open or non-healing wounds on toes or foot) to moderate claudicant status (e.g. limb pain during movement)
  • Through 6 months, these data demonstrate on average PAD patients (Rutherford 2-6) post-PVI have maintained good outcomes and positive changes in Rutherford classification
Change in Rutherford Classification Following Endovascular Intervention
Baseline 30 Days 6 Months
RC 2-3 2.8 1.3 1.4
RC 4-5 4.5 3.1 2.3
RC 6 6.0 5.5 4.6

Table 1: All Rutherford Classes show improvement in RC from baseline to 30 days. RC4-5 and RC6 show continued improvement from 30 days to 6 months while RC2-3 maintains improvement at 6 months.

Said Dr. Gray, “Following endovascular intervention, we saw a marked improvement across all Rutherford Classes at six months: Rutherford 4-5 and Rutherford 6 patients showed continued improvement from 30 days to six months, while Rutherford 2-3 patients maintained improvement at six months. We also saw a high freedom from major adverse events across all classes. This suggests that endovascular intervention is an alternative treatment option in place of watchful waiting or even primary amputation.”

Rutherford Classification
RC 2-3 RC 4-5 RC 6
Freedom from (FF) MAE (6-month) 92.6% 81.2% 73.7%
FF Major Amputation 99.8% 96.8% 87.1%
FF Target Vessel Revascularization (TVR) 93.0% 83.1% 85.1%
FF Death 97.1% 95.3% 85.1%

Table 2: High freedom from MAEs at 6 months across all Rutherford Classes. Kaplan-Meier method used to estimate event-free rates. MAE defined as death (=30 days after the procedure), major amputation of the target limb, and TVR.

According to VascuQoL, a patient-reported, PAD-specific health-related quality of life questionnaire, patients in the LIBERTY 360° study reported improved quality of life across all Rutherford Classes, including such measures as physical activity, symptoms and pain.

During a concurrent session at ISET, Dr. Mustapha highlighted the importance the LIBERTY 360° Rutherford 6 data will have on the endovascular field. He stated, “LIBERTY 360° is novel in that it addresses all Rutherford Classes, including Class 6, representing some of the most challenging and life-threatening PAD cases. Six-month data suggests that these patients can be treated successfully with endovascular interventions – a significant step in establishing a new standard of care for this difficult-to-treat population.”

Additionally it was shared that the recently released 2016 Guidelines on the Management of Patients with PAD from the AHA/ACC support this data, stating:

  • Revascularization is a reasonable treatment option for patients with lifestyle-limiting claudication and an inadequate response to medical management and exercise; and
  • An evaluation for revascularization options should be performed by an interdisciplinary care team before amputation in the patient with CLI

Said Scott Ward, CSI chairman and chief executive officer, “We’re encouraged by the six-month results from LIBERTY 360° and the implications for patients suffering from severe forms of PAD. We look forward to releasing one-year results later this year.”

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 290,000 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.

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