Cardiovascular Systems, Inc. (CSI), announced today it has received FDA clearance of its new Diamondback 360 60cm Peripheral Orbital Atherectomy Systems (OAS) for the treatment of peripheral arterial disease (PAD).
“Receiving FDA clearance for our new 60cm, 4 French (4 Fr) devices demonstrates CSI’s commitment to advancing technology and expanding the interventional market,” said David L. Martin, CSI president and chief executive officer. “We’re providing physicians with broader treatment options for challenging lesions in the lower leg, often associated with Critical Limb Ischemia, or CLI, which if left untreated may result in lower limb amputation.
“Our new 60cm Diamondback devices are compatible with 4 Fr introducer sheaths. The use of smaller sheaths has been shown to reduce procedure times, enable quicker patient recovery and have less procedural complications from bleeding, providing additional procedural benefits to patients and physicians.” CSI’s new Diamondback Peripheral 60cm systems are available in two crown designs, the 1.25mm Micro Crown, and the 1.25mm Solid Crown. Each device offers a shorter shaft length, a smaller profile and a more flexible shaft than their predecessors for improved ease of use. These products are the latest release of CSI’s new Low Profile Diamondback 360 Peripheral Orbital Atherectomy family of products, building on the success of the recently released 4 Fr compatible Diamondback 360 1.25 Micro Crown (145cm shaft) device.
Martin concluded, “CSI is redefining minimally invasive treatment with our new 4 Fr compatible systems—available in two shaft lengths (60cm and 145cm) and two crown designs, the 1.25mm Micro Crown and 1.25mm Solid Crown. These systems, combined with our growing body of clinical data, provide physicians with new treatment solutions in an effort to achieve a new standard of care for patients with PAD while expanding the market for minimally invasive procedures.” More than 12 million Americans suffer from PAD and approximately 25 percent of these will progress to CLI, which is associated with complex occlusions in the tibial arteries (responsible for supplying blood flow to the lower leg). It is estimated that up to 20 percent of these occlusions are unable to be treated from the traditional femoral artery access site. However, recent advancements in technology and techniques have made the use of retrograde tibiopedal access (where physicians achieve access through the arteries in the foot or ankle) more popular; expanding the treatment options available for PAD.