Cardiovascular Systems (CSII) Reports Publication of Statistically Significant Data for CALCIUM 360
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Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announced publication of 12-month results from its CALCIUM 360° study in the Journal of Endovascular Therapy, August 2012.
CALCIUM 360° is a prospective, randomized, multi-center study of 50 patients (64 lesions), comparing one-year safety and efficacy of CSI’s Diamondback 360° atherectomy device followed by percutaneous transluminal angioplasty (PTA), versus PTA alone, to treat calcified infrapopliteal lesions in patients with critical limb ischemia.
Based on the study results, the Diamondback 360° system provides significantly lower major serious adverse events (major amputation, all-cause mortality, and TLR/TVR) than PTA alone. The Diamondback arm demonstrated that lower balloon pressure is needed to achieve optimal dilatation (p <0.001), resulting in fewer procedural events for peripheral arterial disease (PAD) patients. At 12 months, the Diamondback 360° group was 93.3 percent free of major adverse events (major amputation, all-cause mortality and TLR/TVR) versus just 57.9 percent of the balloon angioplasty alone (p = 0.006) group.
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CALCIUM 360° is a prospective, randomized, multi-center study of 50 patients (64 lesions), comparing one-year safety and efficacy of CSI’s Diamondback 360° atherectomy device followed by percutaneous transluminal angioplasty (PTA), versus PTA alone, to treat calcified infrapopliteal lesions in patients with critical limb ischemia.
Based on the study results, the Diamondback 360° system provides significantly lower major serious adverse events (major amputation, all-cause mortality, and TLR/TVR) than PTA alone. The Diamondback arm demonstrated that lower balloon pressure is needed to achieve optimal dilatation (p <0.001), resulting in fewer procedural events for peripheral arterial disease (PAD) patients. At 12 months, the Diamondback 360° group was 93.3 percent free of major adverse events (major amputation, all-cause mortality and TLR/TVR) versus just 57.9 percent of the balloon angioplasty alone (p = 0.006) group.
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