Technology | Atherectomy Devices | July 22, 2015

FDA Clears Next-Generation Guide Wire for Cardiovascular Systems' Peripheral Orbital Atherectomy Systems

ViperWire Advance offers greater flexibility and navigation with calcified lesions in torturous arterial anatomy

CSI, ViperWire Advance Peripheral Guide Wire with Flex Tip, Stealth, Diamondback

Diamondback 360 Peripheral OAS image courtesy of Cardiovascular Systems Inc.

July 22, 2015 — Cardiovascular Systems Inc. announced that it has received U.S. Food and Drug Administration (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 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.

 

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.

The Stealth 360 and Diamondback 360 Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present.

For more information: www.csi360.com

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