Cardiovascular Systems Receives FDA Clearance for New Peripheral Diamondback Device

Cardiovascular Systems Inc. has received U.S. Food and Drug Administration (FDAO clearance for the new 4 French (4 Fr) 1.25 Solid Diamondback 360 Peripheral Orbital Atherectomy System (OAS) for the treatment of peripheral artery disease (PAD).

Specifically, the clearance covers the company’s 145 centimeter-long new 1.25 millimeter Diamondback 360 Solid Crown, 4 Fr sheath compatible; and the Modified 1.25 millimeter Diamondback 360 Micro Crown, 4 Fr sheath compatible.

“We are committed to advancing Cardiovascular System’s OAS technology, and redefining minimally invasive therapies,” said David L. Martin, CSI president/CEO. “Last year we secured FDA clearance for our 60 centmeter peripheral devices which opened up access sites in the foot, allowing physicians to treat challenging lesions in the lower leg. This new clearance further expands our 4 Fr, low-profile product portfolio, with longer and enhanced devices. Physicians now have the ability to treat PAD below the knee through as small as 4 Fr access sites in the groin, or to treat the upper leg from foot access sites.”

CSI’s Diamondback Peripheral 145 centimeter systems are available in two crown designs, the 1.25 millimeter Solid Crown, and the 1.25 millimeter Micro Crown. Both devices offer a smaller profile and a more flexible shaft for improved ease of use, the company claims.

“The use of smaller access sheaths has been shown to reduce procedure times, enable quicker patient recovery, and result in fewer procedural complications from bleeding, providing additional procedural benefits to patients and physicians—in addition to expanding physicians’ treatment options,” said Cezar Staniloae, M.D., of NYU Medical Center in New York, N.Y.

As many as 18 million Americans, most over age 65, suffer from PAD, which is caused by plaque accumulation 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.

Moreover, approximately 25 percent of PAD cases will progress to critical limb ischemia (CLI), which is associated with complex occlusions in the tibial arteries (responsible for supplying blood flow to the lower legs and feet). It is estimated that up to 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, thereby expanding the treatment options available for PAD patients.

The Stealth 360 and Diamondback 360 Peripheral Orbital Atherectomy Systems 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.

The Stealth 360 and Diamondback 360 Peripheral Orbital Atherectomy systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.

Based in St. Paul, Minn., Cardiovascular Systems develops and commercializes vascular and coronary disease treatment. The FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. To date, nearly 182,000 of the company’s devices have been sold throughout the United States.