Cardiovascular Systems receives FDA clearance for new peripheral Diamondback device


Cardiovascular Systems has received FDA clearance for the new 4 French (4 Fr) 1.25 Solid Diamondback 360 peripheral orbital atherectomy system for the treatment of peripheral artery disease.

Specifically, the clearance covers the company’s 145cm-long:

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

“We are committed to advancing Cardiovascular Systems’ proven orbital atherectomy system technology, and redefining minimally invasive therapies,” said David L Martin, Cardiovascular Systems 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 peripheral artery disease below the knee through as small as 4 Fr access sites in the groin, or to treat the upper leg from foot access sites.”

Cardiovascular Systems’ 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.

“Cardiovascular Systems’ new 4 Fr compatible Diamondback devices are redefining interventional vascular medicine,” said Cezar Staniloae, NYU Medical Center, USA. “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.”

Approximately 25% of peripheral artery disease cases will progress to critical limb ischaemia, which is associated with complex occlusions in the tibial arteries. 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 more popular, thereby expanding the treatment options available for peripheral artery disease patients.

Cardiovascular Systems believes that millions of patients with peripheral artery disease may benefit from treatment with orbital atherectomy utilizing the Stealth 360 and Diamondback 360 systems, minimally invasive catheter systems. 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 preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. The company believes that stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.