FDA clears Diamondback devices


Cardiovascular Systems has announced that it has received US Food and Drug Administration (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 Cardiovascular System’s commitment to advancing technology and expanding the interventional market,” says David L Martin, Cardiovascular Systems 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.”

Cardiovascular System’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 Cardiovascular System’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.