FDA clears guidewire for Cardiovascular Systems’ peripheral orbital atherectomy systems


Cardiovascular Systems has received FDA clearance for its new ViperWire Advance peripheral guidewire with flex tip for its peripheral orbital atherectomy systems (OAS). The new guidewire 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.

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 guidewire also provides improved trackability through tortuous peripheral arteries.

Additional features and enhancements of the ViperWire Advance include a nitinol support coil, for a more durable tip and the ability to be reshaped for multiple uses; and a larger proximal core, for improved kink resistance and more delivery support for adjunctive devices.

“We designed the ViperWire Advance to improve ease-of-use for our peripheral orbital atherectomy systems when treating complex calcified lesions,” said David L Martin, Cardiovascular Systems 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 peripheral arterial disease in a traditionally difficult-to-treat patient population.”

The company anticipates launching the device in early August 2015. The guidewire is for use with Cardiovascular System’s 145cm Stealth 360 and Diamondback 360 peripheral OAS.