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Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today announced CONFIRM study series data presented at the 2013 International Symposium on Endovascular Therapy (ISET). Results show that CSI’s minimally invasive orbital atherectomy system is an effective treatment for peripheral arterial disease (PAD). CSI’s technology protects healthy vessel tissue while removing even the most difficult-to-treat plaque throughout the leg with fewer complications. The study titled “Procedural Effectiveness of Orbital Technology in More Than 3,100 Patients with Infra-inguinal Disease: Results from the CONFIRM Series” was part of a late-breaking presentation at ISET.
“The 3,000-plus real-world patients studied in the CONFIRM series shows that CSI’s orbital atherectomy system safely and effectively treats moderate-to-severely calcified lesions,” said presenter Dr. Tony Das, Cardiology and Interventional Associates, Dallas, Texas. “Orbital atherectomy led to low bail-out-stent usage, low adverse procedural-event rates and improved lesion compliance. Additionally, smaller randomized studies point to improved vessel durability and long-term outcomes—both of which are a first for atherectomy trials in the peripheral vascular space.”
The prevalence of arterial calcium is vastly underestimated in medicine today. Calcium, even if it isn’t visible through angiography, is present in about 65 percent of the 2.5 million people diagnosed annually with PAD. Moreover, calcium leads to poor outcomes and higher treatment costs when traditional balloon and stent therapies are used—including dissection, vessel wall trauma and stent fracture.
David L. Martin, CSI president and chief executive officer said: “CONFIRM reinforces the effectiveness of CSI’s orbital atherectomy in treating 'real world' patients. The dataset presented today is the largest ever for PAD, and the CONFIRM study series shows consistent, repeatable results across numerous interventional physicians. CONFIRM gives physicians confidence that our technology is an effective and safe PAD treatment for patients.”
The CONFIRM series consisted of three studies that enrolled more than 3,100 patients with 4,700 lesions at 350 sites across the United States from 2009 to 2011. A majority of the lesions had moderate to severe calcium. During the initial study, physicians treated lesions to maximize the luminal gain, while the second and third study focused on removing calcium to change vessel compliance. Each study utilized a progressively smaller crown which reduced slow flow, vessel closure and spasms.