FDA clears new Cardiovascular Systems percutaneous orbital atherectomy system

|About: Cardiovascular Systems... (CSII)|By:, SA News Editor

The FDA approves the 4 French 1.25 (mm) Solid Diamondback 360 Peripheral Orbital Atherectomy System (OAS) developed by Cardiovascular Systems (CSII +0.9%) for the treatment of peripheral artery disease (PAD). The smaller access sheath of the interventional vascular device enables quicker patient recovery and fewer procedural complications from bleeding.

PAD, affecting ~18M Americans, is caused by plaque accumulation in peripheral arteries, typically pelvis or leg, that reduces blood flow. If untreated, it can lead to severe pain, immobility, non-healing wounds and the potential for limb amputation. The incidence of PAD is growing at a double-digit rate due to the rise of diabetes and obesity. About 25% of PAD cases progress to critical limb ischemia (CLI) which is characterized by complex occlusions in the tibial arteries that supply blood flow to the feet and lower legs. About 20% of CLI cases cannot be treated by peripheral intervention via traditional access through the femoral artery. Newer systems, like the 1.25 Diamondback, offer physicians alternative access through the arteries in the foot or ankle.

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