FDA clearance for Cardiovascular Systems’ device

FDA clearance for Cardiovascular Systems’ device

Clearance expands company's low-profile, minimally invasive product portfolio, broadens treatment options for patients and physicians.

May 4, 2015
Manufacturing Group
Contract Manufacturing Devices/Implants/Equipment Industry/Regulations Design/Engineering

St. Paul, Minnesota – Cardiovascular Systems Inc. officials announce that the company has received FDA 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 145cm long:

  • New 1.25mm Diamondback 360 Solid Crown, 4 Fr sheath compatible
  • Modified 1.25mm Diamondback 360 Micro Crown, 4 Fr sheath compatible

“We are committed to advancing CSI’s proven OAS technology, and redefining minimally invasive therapies,” said David L. Martin, CSI president and chief executive officer. “Last year we secured FDA clearance for our 60cm 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 145cm systems are available in two crown designs, the 1.25mm Solid Crown, and the 1.25mm Micro Crown. Both devices offer a smaller profile and a more flexible shaft for improved ease of use.

“CSI’s new 4 Fr compatible Diamondback devices are redefining interventional vascular medicine,” said Dr. Cezar Staniloae, NYU Medical Center. “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.”

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% 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% 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.

Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Stealth 360 and Diamondback 360 Peripheral Orbital Atherectomy Systems, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue – a critical factor in Cardiovascular Systems, Inc. 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.

Source: Cardiovascular Systems Inc.