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

Related Content

Medtronic Receives FDA Clearance for Riptide Aspiration System
Technology | Atherectomy Devices | January 16, 2018
Medtronic plc announced the company’s Neurovascular business unit received U.S. Food and Drug Administration (FDA)...
Avinger Announces Treatment of First Patients With Next-Generation Pantheris
News | Atherectomy Devices | January 09, 2018
January 9, 2018 – Avinger Inc. announced that Arne Schwindt, M.D., a vascular surgeon at St.
Avinger Receives 510(k) Clearance for Pantheris Image-Guided Atherectomy Device Modifications
Technology | Atherectomy Devices | November 20, 2017
November 20, 2017 — Avinger Inc. announced in October that the company received 510(k) clearance from the U.S.
Avinger Receives CE Mark for In-Stent Restenosis Indication With Pantheris Image-Guided Atherectomy
Technology | Atherectomy Devices | September 29, 2017
Avinger Inc. recently announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the...
Ra Medical Systems Receives FDA Clearance for New Peripheral Artery Disease Treatment
Technology | Atherectomy Devices | May 30, 2017
The U.S. Food and Drug Administration (FDA) announced that it has granted market clearance to Ra Medical Systems for...
CSI recall for saline pump on its atherectomy system
News | Atherectomy Devices | April 19, 2017
Cardiovascular Systems Inc. (CSI) announced April 18 it had initiated a voluntary recall of its 7-10014 Saline Infusion...
Cardiovascular Systems Inc., CSI, ECLIPSE clinical trial, Diamondback 360 Coronary Orbital Atherectomy System, first subject enrolled
News | Atherectomy Devices | April 04, 2017
Cardiovascular Systems Inc., in partnership with the Cardiovascular Research Foundation (CRF), announced the first...
CSI, LIBERTY 360 Study, ISET 2017, six-month data, lower extremity PAD
News | Atherectomy Devices | February 08, 2017
February 8, 2017 — Cardiovascular Systems (CSI) presented six-month data from its LIBERTY 360° post-market study in a
Avinger, VISION Study, two-year outcomes, LINC, Lumivascular technology, Pantheris, OCT-guided atherectomy
News | Atherectomy Devices | February 03, 2017
Avinger Inc. recently announced positive two-year clinical data from the pivotal VISION study of the company’s...
Overlay Init