FDA Clears New Size of Atherectomy System from Cardiovascular Systems

Cardiovascular Systems has obtained U.S. 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 60-centimeter 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; 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 favorable patient outcomes.

“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,” CSI President/CEO David L Martin said.

In the United States, roughly 12 million people suffer from PAD and approximately 25 percent of these patients will progress to CLI, which is associated with complex occlusions in the tibial arteries (responsible for supplying blood flow to the lower leg).

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

Currently, CSI’s new Diamondback peripheral 60 centimeter systems are available in two designs, the 1.25 millimeter Micro Crown, and the 1.25 millimeter 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 recent launch of Fr compatible Diamondback 360 1.25 Micro Crown (145 centimeter 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 throughout the United States.