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Landmark Study from Cardiovascular Systems Demonstrates Sustained Benefit of Endovascular Intervention in Patients with Lower Extremity Peripheral Artery DiseaseCardiovascular Systems (CSI (News - Alert)) (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. 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
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."
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:
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.
Safe Harbor
About Peripheral Artery Disease (PAD) 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 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 Caution: Federal law (USA) restricts this device to sale by, or on the order of, a physician. View source version on businesswire.com: http://www.businesswire.com/news/home/20170206006041/en/ |