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Cardiovascular Systems, Inc. (CSI) develops and commercializes interventional technologies for the treatment of cardiovascular disease. The company's goal is to provide physicians with safer, more effective tools to help the nearly 12 million Americans suffering from peripheral arterial disease (PAD) - blockages in the arteries of the leg - and the potential catastrophic risk of limb amputation.
The company's primary product, the Diamondback 360® System, is a minimally invasive catheter designed to safely sand away the plaque that builds up in peripheral arteries, while preserving healthy arterial tissue. Elimination of plaque can restore blood flow and mobility, heal wounds and save limbs. The Diamondback 360° treats all plaque morphologies, but is particularly effective in hard, calcified plaque that, until now, has been very difficult to treat using existing technologies. Since receiving 510(k) FDA clearance and the September 2007 product launch, more than 37,000 procedures have been performed in leading hospitals across the United States. CSI's unprecedented safety profile means more patients are finding relief and improved outcomes, with significant economic benefits.
Under the leadership of CEO Dave Martin, CSI is committed to providing clinically useful data to physicians to advance the standard of care for PAD patients. CSI was the first, and so far the only, company to conduct a prospective, multi-center clinical trial with a prior investigational device exemption, or IDE, to support a 510(k) clearance for an atherectomy device.
Two randomized studies, COMPLIANCE 360° and CALCIUM 360°, are evaluating the effectiveness of the Diamondback 360° in lesions above and below the knee, respectively. Through these studies and the company's CONFIRM registry, CSI is accumulating data on more than 1,700 PAD patients.
CSI believes the unique features of the Diamondback 360° will also be advantageous in coronary lesions and has launched the ORBIT II pivotal trial for a coronary application - a major market opportunity.
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