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News Breaks | | | | August 30, 2012 | | 11:51 EDT |  | CSII | Cardiovascular Systems publishes 12-month results from Calcium 360 study
Cardiovascular Systems 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, 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% free of major adverse events (major amputation, all-cause mortality and TLR/TVR) versus just 57.9% of the balloon angioplasty alone (p = 0.006) group. According to David L. Martin, CSI president and CEO, "The CALCIUM 360 study demonstrates that our technology provides patients and physicians with a better therapy. It provides optimal balloon dilatation and significantly lowers complications. Our expanding clinical data set continues to demonstrate that the Diamondback 360 system is setting a new standard for treating calcified lesions." | |
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