FDA clearance for Cardiovascular Systems’ device

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.”

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