1. Articles from Avinger, Inc.

    1-15 of 15
    1. Avinger Announces Publication of SCAN Clinical Study in Peer-Reviewed Journal

      Avinger Announces Publication of SCAN Clinical Study in Peer-Reviewed Journal

      vinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that the results of its SCAN clinical study have been published in the peer-reviewed journal BMC Medical Imaging. SCAN is a prospective, non-inferiority, post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries. Study results showed that OCT imaging with Avinger's Pantheris system demonstrated statistical superiority or equivalence to IVUS on all parameters evaluated. While OCT has been documented to ...

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    2. Avinger Enrolls First Patient in IMAGE-BTK Clinical Study Evaluating Safety and Efficacy Endpoints for Pantheris SV

      Avinger Enrolls First Patient in IMAGE-BTK Clinical Study Evaluating Safety and Efficacy Endpoints for Pantheris SV

      Avinger, Inc. (Nasdaq:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the initiation of the IMAGE-BTK clinical study for its Pantheris SV image-guided atherectomy system. IMAGE-BTK is a post-market trial designed to evaluate safety and efficacy endpoints for Pantheris SV in the treatment of peripheral artery lesions below-the-knee (BTK). Dr. Thomas Davis, an interventional cardiologist at Eastlake Cardiovascular, P.C. in Saint Claire Shores, Michigan, enrolled the first patient in IMAGE-BTK and will serve as the principal investigator of the study. After ...

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    3. Avinger Announces Successful First Procedures in Europe with Ocelaris Chronic Total Occlusion (CTO) Image-Guided Crossing Device

      Avinger Announces Successful First Procedures in Europe with Ocelaris Chronic Total Occlusion (CTO) Image-Guided Crossing Device

      Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the first clinical experiences with the Ocelaris next-generation CTO crossing system utilizing Avinger's proprietary image-guided technology platform. Dr. Arne Schwindt, a vascular surgeon at St. Franziskus Hospital Münster, and Dr. Michael Lichtenberg, an interventional angiologist at Klinikum Hochsauerland, Arnsberg, used Ocelaris in multiple procedures across a variety of different lesion types and anatomy both above and below the knee. Avinger plans to continue supporting first cases with Ocelaris at ...

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    4. Avinger Receives CE Marking for Ocelaris, a Next-Generation Image-Guided CTO Crossing System

      Avinger Receives CE Marking for Ocelaris, a Next-Generation Image-Guided CTO Crossing System

      Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based systems for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced it has gained Conformité Européenne (CE) Marking for Ocelaris, a next-generation chronic total occlusion (CTO) crossing system utilizing Avinger's proprietary image-guided technology platform. CE Marking allows clinical use of Ocelaris in the European Union (EU) and certain other countries that recognize CE Marking. Ocelaris is not available for clinical use in the United States at this time. Ocelaris is a product line extension of Avinger's Ocelot family ...

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      Mentions: FDA Avinger
    5. Avinger Announces Full Commercial Launch of Pantheris SV

      Avinger Announces Full Commercial Launch of Pantheris SV

      Avinger, Inc. (NASDAQ: AVGR ), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the full commercial launch of the Pantheris SV (small vessel) image-guided atherectomy system in the U.S. All current and prospective Lumivascular accounts are now eligible to order the Pantheris SV device. Avinger launched Pantheris SV at select Avinger sites in late July in order to demonstrate the product's ease of use and efficiency across a variety of user approaches and vascular conditions in a real-world clinical setting, as well ...

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    6. Avinger Announces Commercial Launch and First Patients Treated in Hong Kong

      Avinger Announces Commercial Launch and First Patients Treated in Hong Kong

      Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the commercial launch of its Lumivascular products in Hong Kong. Avinger has an exclusive distribution agreement with Integmed Ltd. for the sale and marketing of Avinger’s Pantheris image-guided atherectomy and Ocelot image-guided chronic total occlusion (CTO) crossing systems in Hong Kong. The first shipment of devices has been made under the agreement and training of Integmed’s sales and clinical support teams has been completed. Dr. Yiu Che Chan, a highly-experienced vascular ...

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    7. Avinger Announces Presentations by Key Opinion Leaders at AMP 2019 Clinical Conference

      Avinger Announces Presentations by Key Opinion Leaders at AMP 2019 Clinical Conference

      Avinger, Inc. (NASDAQ: AVGR ), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced four podium presentations featuring the Company’s Lumivascular technology at the annual AMP (Amputation Prevention Symposium) conference occurring last week. Key opinion leaders in the fields of interventional cardiology highlighted Avinger ’s Lumivascular technology, which includes the Pantheris family of image-guided atherectomy products and the Ocelot family of image-guided chronic total occlusion (CTO) crossing products, in the following sessions: Dr. Thomas Davis, an interventional cardiologist at Eastlake Cardiovascular and one ...

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    8. Avinger Announces Pantheris SV Limited Launch and Successful Treatment of First Patients in the United States

      Avinger Announces Pantheris SV Limited Launch and Successful Treatment of First Patients in the United States

      Avinger, Inc. ( Nasdaq: AVGR ), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in four U.S. sites have successfully treated several patients with the Pantheris SV (Small Vessel) image-guided atherectomy system. These initial cases are part of a limited launch at up to 13 leading clinical centers prior to expanding commercial distribution to additional treatment facilities in the U.S. Pantheris SV, a product line extension of Avinger’s onboard image-guided atherectomy platform, expands Avinger’s portfolio of atherectomy devices for ...

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    9. Avinger Enrolls First 50 Patients in INSIGHT Clinical Trial

      Avinger Enrolls First 50 Patients in INSIGHT Clinical Trial

      Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the 50 th patient enrolled in its INSIGHT clinical trial. The INSIGHT trial is a prospective, global, single arm, multi-center study to evaluate the safety and effectiveness of the Pantheris ® Lumivascular atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries. Dr. Jaafer Golzar, Avinger’s Chief Medical Officer and a highly experienced interventionalist, noted, “We are pleased to have the first 50 cases completed as part of our INSIGHT IDE study. Early ...

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      Mentions: FDA Avinger
    10. Avinger Announces Commercial Launch of Ocelot in Australia

      Avinger Announces Commercial Launch of Ocelot in Australia

      First Patients Treated Successfully in Australia with Image-Guided CTO-Crossing Device REDWOOD, CA / ACCESSWIRE / July 8, 2019 / Avinger, Inc. (NASDAQ: AVGR ), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the commercial launch of its Ocelot image-guided chronic total occlusion (CTO) crossing system in Australia. As part of the Company’s exclusive distribution agreement with Diverse Devices Pty Ltd. for Avinger’s proprietary Lumivascular products in Australia, Ocelot completed the registration process with the Therapeutic Goods Administration (TGA) and is included on the Australian Register of Therapeutic ...

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    11. Avinger Announces Successful Treatment of 1,000th Patient with Next-Generation Pantheris Device

      Avinger Announces Successful Treatment of 1,000th Patient with Next-Generation Pantheris Device

      Avinger, Inc. (AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced that physicians in 78 clinical sites have successfully treated more than 1,000 patients with the next-generation Pantheris image-guided atherectomy system. The next-generation Pantheris was launched on a limited basis in the U.S. following receipt of 510(k) clearance by the U.S. Food and Drug Administration (FDA) in late May 2018 and features a number of improvements intended to augment the performance and reliability of the product. Importantly ...

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    12. Avinger Announces Preliminary Analysis of Results from SCAN Clinical Study

      Avinger Announces Preliminary Analysis of Results from SCAN Clinical Study

      Avinger, Inc. (Nasdaq: AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the release of the preliminary analysis of results from its SCAN clinical study, a post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries. Initial analysis of the SCAN data indicated that OCT imaging with Avinger’s Pantheris System showed statistical superiority or equivalence to IVUS on all parameters evaluated. Avinger had previously announced completion of enrollment in the SCAN study in August 2018. During the study, 120 OCT and IVUS matched images ...

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      Mentions: FDA Avinger
    13. Avinger Announces Successful Treatment of 500th Patient with Next-Generation Pantheris Device

      Avinger Announces Successful Treatment of 500th 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 59 sites globally have successfully treated more than 500 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 and features a number of improvements intended to augment the performance and reliability of the product. Importantly, clinical results have remained consistently positive ...

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      Mentions: FDA Avinger
    14. Avinger Announces Commercial Launch in Australia

      Avinger Announces Commercial Launch in Australia

      Avinger, Inc. ( NASDAQ: AVGR ), a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD), today announced the commercial launch of its Pantheris image-guided atherectomy system in Australia. Avinger recently completed an exclusive distribution agreement with Diverse Devices Pty Ltd. for the sales and marketing of Avinger’s proprietary Lumivascular products in Australia. In addition, the Company announced it has received notice from Australia’s Therapeutic Goods Administration (TGA) that the Pantheris image-guided atherectomy system has been included on the Australian Register of Therapeutic Goods, which permits ...

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    15. Avinger’s Next Generation Pantheris Featured in Live Case Transmission at Leipzig Interventional Course 2018

      Avinger’s Next Generation Pantheris Featured in Live Case Transmission at Leipzig Interventional Course 2018

      Avinger, Inc. (NASDAQ: AVGR ), a leading developer of innovative treatments for peripheral artery disease (PAD), announced that its next generation Pantheris® Lumivascular atherectomy system was featured in a live case transmission at Leipzig Interventional Course (LINC) 2018 held from January 30th through February 2nd at the Trade Fair Leipzig, in Leipzig, Germany. LINC is a leading global forum for new methods in the field of vascular medicine that brings together medical professionals from around the world who perform endovascular interventions. Yesterday Drs. Arne Schwindt and Stefan Stahlhoff, vascular surgeons from St. Franziskus Hospital in Münster, Germany, used the next ...

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    1-15 of 15
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    Avinger’s Next Generation Pantheris Featured in Live Case Transmission at Leipzig Interventional Course 2018 Avinger Announces Commercial Launch in Australia Avinger Announces Successful Treatment of 500th Patient with Next-Generation Pantheris Device Avinger Announces Preliminary Analysis of Results from SCAN Clinical Study Avinger Announces Successful Treatment of 1,000th Patient with Next-Generation Pantheris Device Avinger Announces Pantheris SV Limited Launch and Successful Treatment of First Patients in the United States Avinger Announces Presentations by Key Opinion Leaders at AMP 2019 Clinical Conference Avinger Announces Commercial Launch and First Patients Treated in Hong Kong Avinger Announces Full Commercial Launch of Pantheris SV Avinger Announces Successful First Procedures in Europe with Ocelaris Chronic Total Occlusion (CTO) Image-Guided Crossing Device Fantom Encore Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study Assessment of Microcirculatory Dysfunction in Septic Shock Patients by OCTA