Cardiovascular Systems has obtained the US Food and Drug Administration (FDA) clearance for a new size of its Diamondback 360 peripheral orbital atherectomy system (OAS), designed for the treatment of peripheral arterial disease (PAD).
Diamondback 360 60cm atherectomy system offers a shorter shaft length, a smaller profile and a more flexible shaft than their predecessors for improved ease of use. The new 60cm Diamondback device is compatible with 4 Fr introducer sheaths.
According to the company, the new, lower-profile device may help physicians perform quicker operations, shorten patient recovery times and cut down on procedural complications.
CSI president and CEO David L. Martin said receiving FDA clearance for company’s new 60cm, 4 French (4 Fr) devices demonstrates CSI’s commitment to advancing technology and expanding the interventional market.
"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," Martin added.
Currently, CSI’s new Diamondback peripheral 60cm system is available in two crown designs, the 1.25mm Micro Crown, and the 1.25mm Solid Crown.
Following the success of recently released 4 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 has secured FDA approval. Photo: courtesy of Cardiovascular Systems, Inc./BusinessWire