Cardiovascular Systems (CSII) Receives FDA Approval for ViperWire Advance Peripheral Guide Wire with Flex Tip

July 6, 2015 5:02 PM EDT

Cardiovascular Systems (NASDAQ: CSII) announced that it has received FDA clearance for its new ViperWire Advance Peripheral Guide Wire with Flex Tip for their Peripheral Orbital Atherectomy Systems (OAS). The new guide wire provides physicians with improved flexibility, navigation and ease-of-use—particularly in hard-to-reach, tortuous vessels—when treating arterial calcium associated with peripheral artery disease (PAD).

Building on the success of the current ViperWire Advance, this next-generation wire offers a reduction in tip stiffness, with comparable torque transfer, making it easier for physicians to navigate vasculature. The guide wire also provides improved trackability through tortuous peripheral arteries.

Additional features and enhancements of the ViperWire Advance Guide Wire with Flex Tip include:

  • A Nitinol support coil, for a more durable tip and the ability to be reshaped for multiple uses; and
  • Larger proximal core, for improved kink resistance and more delivery support for adjunctive devices.

“We designed the ViperWire Advance with Flex Tip to improve ease-of-use for our peripheral orbital atherectomy systems when treating complex calcified lesions,” said David L. Martin, CSI president and chief executive officer. “By improving the predictability and deliverability of the guide wire, physicians will now have more confidence in their ability to navigate tortuous peripheral anatomy and address PAD in a traditionally difficult-to-treat patient population.”

CSI anticipates launching ViperWire Advance with Flex Tip in early August 2015. The guide wire is for use with CSI’s 145 cm Stealth 360® and Diamondback 360® Peripheral OAS.

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