Cardiovascular Systems gets FDA clearance for low profile Diamondback atherectomy system

11 March 2014 (Last Updated November 22nd, 2018 11:18)

Cardiovascular Systems has obtained US Food and Drug Administration (FDA) clearance for a new size of its Diamondback 360 peripheral orbital atherectomy system (OAS), designed for treating peripheral arterial disease (PAD).

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Cardiovascular Systems has obtained US Food and Drug Administration (FDA) clearance for a new size of its Diamondback 360 peripheral orbital atherectomy system (OAS), designed for treating peripheral arterial disease (PAD).

The new FDA cleared 60cm model of its Diamondback 360 atherectomy system offers a shorter shaft length, a smaller profile and a more flexible shaft than predecessors for improved ease-of-use.

It is compatible with 4 French (Fr) introducer sheaths and use of smaller sheaths has been shown to reduce procedure times, enable quicker patient recovery and have fewer procedural complications from bleeding, providing additional procedural benefits to patients and physicians.

Th system is electronically driven by a diamond-coated crown that safely eliminates plaque, while preserving healthy vessel tissue.

It ultimately helps enable successful stent deployment, which facilitates more favourable patient outcomes.

CSI president and CEO David L Martin said: "We're providing physicians with broader treatment options for challenging lesions in the lower leg, often associated with critical limb ischemia, which if left untreated may result in lower limb amputation."

In the US, around 12 million people suffer from PAD and approximately 25% 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).

"We're providing physicians with broader treatment options for challenging lesions in the lower leg, often associated with critical limb ischemia, which if left untreated may result in lower limb amputation."

According to the company, an estimated 20% of these occlusions are unable to be treated from the traditional femoral artery access site.

Currently, CSI's new Diamondback peripheral 60cm systems are available in two designs, the 1.25mm Micro Crown, and the 1.25mm Solid Crown.

The Diamondback 360 peripheral orbital atherectomy systems are indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae, the company said.

Following the success of recent launch of Fr compatible Diamondback 360 1.25 Micro Crown (145cm shaft) device, the company has now introduced the family of new low profile Diamondback 360 peripheral orbital atherectomy products.

The FDA granted 510(k) clearance for the use of the Diamondback OAS in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback OAS in coronary arteries.

According to the company, around 135,000 of CSI's devices have been sold to major institutions across the US.


Image: The low profile, 60cm Diamondback device is designed to expand the treatment of peripheral artery disease. Photo: courtesy of Cardiovascular Systems, Inc./BusinessWire.