1. 1-10 of 10
    1. Avinger Receives CE Marking Approval for Pantheris SV, a New Image-Guided Atherectomy Device Designed to Treat Smaller Vessels

      Avinger Receives CE Marking Approval for Pantheris SV, a New Image-Guided Atherectomy Device Designed to Treat Smaller Vessels

      vinger, Inc. (NASDAQ: AVGR ), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced Conformité Européenne (CE) Marking approval of Pantheris SV (Small Vessel), a product line extension of the Lumivascular atherectomy system. CE Marking allows for distribution of Pantheris SV in the European Union (EU) and certain other countries that recognize the CE Marking. Pantheris SV is not available commercially in the United States at this time. Designed with a lower profile and longer length, Pantheris SV is intended to expand the addressable market for Pantheris by allowing physicians to treat lesions in smaller diameter ...

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      Mentions: Avinger
    2. Avinger Announces Successful Treatment of 200th Patient with Next-Generation Pantheris Device

      Avinger Announces Successful Treatment of 200th Patient with Next-Generation Pantheris Device

      Avinger, Inc. (NASDAQ: AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that physicians in 35 sites globally have successfully treated over 200 patients with the next-generation Pantheris image-guided atherectomy system for the treatment of peripheral artery disease (PAD). The next-generation Pantheris was launched on a limited basis in the U.S. following receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) in late May 2018. The next-generation Pantheris device features a number of improvements intended to augment the performance and reliability of the design, including a simplified single balloon ...

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      Mentions: FDA Avinger
    3. Avinger Announces 510(k) Filing of Pantheris Small Vessel Device

      Avinger Announces 510(k) Filing of Pantheris Small Vessel Device

      Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the Company submitted a new 510(k) application to the U.S Food & Drug Administration (FDA) for the Pantheris SV (Small Vessel) Lumivascular atherectomy system. Pantheris SV is a line extension of the Pantheris family of catheters, the first and only image-guided atherectomy devices for the treatment of PAD. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller diameter vessels and more distal ...

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      Mentions: Avinger
    4. Avinger’s Ocelot Technology Featured in Live Case Transmission at Complex Cardiovascular Catheter Therapeutics (C3) 2018

      Avinger’s Ocelot Technology Featured in Live Case Transmission at Complex Cardiovascular Catheter Therapeutics (C3) 2018

      Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that its Ocelot image-guided chronic total occlusion (CTO) crossing device was featured in a live case on June 19 th at Complex Cardiovascular Catheter Therapeutics (C3) 2018 in Orlando, Florida. Ocelot combines real-time image guidance using optical coherence tomography (OCT) with a proprietary CTO crossing catheter design to aid physicians in the treatment of chronic total occlusions. Dr. Mahir Elder, an interventional cardiologist at the Detroit Medical Center Cardiovascular Institute, performed the case. The patient had previously undergone a failed attempt by another ...

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      Mentions: Avinger
    5. Avinger Announces First-in-Patient use of Extended Nosecone Version of Next Generation Pantheris

      Avinger Announces First-in-Patient use of Extended Nosecone Version of Next Generation Pantheris

      vinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that Arne Schwindt, M.D., a vascular surgeon at St. Franziskus Hospital in Münster, Germany, successfully treated the first three patients with the extended nosecone version of the next generation Pantheris Lumivascular atherectomy system (A400EX). This product is a line extension of the existing next generation platform, with a longer nosecone that enhances the plaque removal capacity of the device in addition to the feature improvements of the next generation of devices. This new device qualifies for commercial sale in the European ...

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    6. Avinger Announces Treatment of First Patients Globally With Next Generation Pantheris

      Avinger Announces Treatment of First Patients Globally With Next Generation Pantheris

      Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced that Arne Schwindt, M.D., a vascular surgeon at St. Franziskus Hospital in Münster, Germany, has successfully treated the first seven patients with the next generation Pantheris Lumivascular atherectomy system. Dr. Schwindt, an experienced operator of Lumivascular technology, used the next generation Pantheris to treat seven separate patients with a variety of lesion types, including in-stent restenosis (ISR), a calcified lesion, and a chronic total occlusion, in arteries above and below the knee. The next generation Pantheris design includes a simplified single balloon ...

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    7. Avinger Receives CE Marking Approval for Next Generation Pantheris Image-Guided Atherectomy Device

      Avinger Receives CE Marking Approval for Next Generation Pantheris Image-Guided Atherectomy Device

      Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced Conformité Européenne (CE) Marking approval for its next generation Pantheris Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of PAD. The novel design features of the next generation of Pantheris include a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a more robust nose cone with the option for more tissue storage capacity, and an enhanced cutter design. “CE Marking approval to market and sell our ...

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      Mentions: Avinger
    8. Avinger Announces Verified Data of 24-Month Outcomes from the Pivotal VISION Study of Lumivascular Technology for Peripheral Artery Disease

      Avinger Announces Verified Data of 24-Month Outcomes from the Pivotal VISION Study of Lumivascular Technology for Peripheral Artery Disease

      Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular™ technology. The VISION study was designed to evaluate the safety and effectiveness of Avinger’s Pantheris® system to perform directional atherectomy while, for the first time ever, allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. Data from the study, which demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints, supported U.S. Food and Drug ...

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      Mentions: FDA Avinger
    9. Avinger Announces 24-Month Outcomes from the Pivotal VISION Study of Lumivascular Technology for Peripheral Artery Disease

      Avinger Announces 24-Month Outcomes from the Pivotal VISION Study of Lumivascular Technology for Peripheral Artery Disease

      Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular™ technology. The VISION study was designed to evaluate the safety and effectiveness of Avinger’s Pantheris™ system to perform directional atherectomy while for the first time ever allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. Data from the study, which demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints, supported U.S. Food and Drug ...

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    10. Highmark Health’s VITAL Program to Evaluate Avinger’s Novel Treatment for Peripheral Artery Disease

      Highmark Health’s VITAL Program to Evaluate Avinger’s Novel Treatment for Peripheral Artery Disease

      Highmark Health, Allegheny Health Network (AHN) andAvinger, Inc. (NASDAQ:AVGR) announced a collaboration today to evaluate Pantheris™, Avinger’s novel image-guided atherectomy device for the treatment of peripheral artery disease (PAD). The partnership is part of Highmark Health’s VITAL (Verification of Innovation by Testing, Analysis and Learning) Innovation Program. Pantheris, which recently received 510(k) clearance from the United States Food & Drug Administration (FDA), represents an important leap forward in atherectomy, a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology utilized in the Pantheris system allows ...

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      Mentions: FDA Avinger
    1-10 of 10
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