FDA Clears PAD Treatment from Cardiovascular Systems

Cardiovascular Systems Inc. (CSI) has received U.S. 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 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.”

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.

“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,” Matin said.

The FDA granted Cardiovascular Systems 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in August 2007. To date, more than 135,000 of CSI’s devices have been sold to leading institutions across the United States. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries.

More than 12 million Americans suffer from PAD and approximately 25 percent 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). An estimated 20 percent of these occlusions are unable to be treated from the traditional femoral artery access site. However, recent advancements in technology and techniques have made the use of retrograde tibiopedal access (where physicians achieve access through the arteries in the foot or ankle) more popular; expanding the treatment options available for PAD.

PAD is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD 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.

The Stealth 360 and Diamondback 360 use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue—a critical factor in preventing reoccurrences. Balloon angioplasty and stents 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.