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CSI receives FDA approval for new Guide Wire for Peripheral OAS

Medical device firm Cardiovascular Systems (CSI) has obtained approval from the US Food and Drug Administration (FDA) for its new ViperWire Advance Peripheral Guide Wire with Flex Tip for Peripheral Orbital Atherectomy Systems (OAS).

The new ViperWire Advance Guide Wire will offer physicians with improved flexibility and navigation when treating arterial calcium associated with peripheral artery disease (PAD).

Cardiovascular Systems president and CEO David Martin said: "We designed the ViperWire Advance with Flex Tip to improve ease-of-use for our peripheral orbital atherectomy systems when treating complex calcified lesions.

"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."

Additional features and enhancements of the new guide wire include Nitinol support coil and larger proximal core.

Nitinol support coil has been designed for a more durable tip and allows to reshape for multiple uses, while larger proximal core is for improved kink resistance and more delivery support for adjunctive devices.

The company intends to launch the new guide wire in early august of this year and it can be used with the firm’s 145cm Stealth 360 and Diamondback 360 Peripheral OAS.