FDA Clears Cardiovascular Systems’ Low Profile, 60cm Diamondback Orbital Atherectomy Devices

Cardiovascular Systems, Inc. has received FDA clearance of its new Diamondback 360® 60cm Peripheral Orbital Atherectomy Systems (OAS) for the treatment of peripheral arterial disease (PAD).

Background

More than 12 million Americans, most over age 65, suffer from PAD, which, left untreated, can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.

Commonly used device options used to open up the peripheral vessels include balloon angioplasty and stents. Both however have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results. This is where orbital atherectomy finds its niche. CSI’s Stealth 360 and Diamondback 360, minimally invasive catheter systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue.

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.

Company comments

“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.”

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.”

Source: Cardiovascular Systems, Inc., Business Wire

Share your thoughts

Your email address will not be published. Required fields are marked *