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    Intact Vascular Announces US Launch of the Tack Endovascular System ® and First Commercial Use

    Intact Vascular, Inc. announced the first commercial use of its Tack Endovascular System in multiple sites across the United States. Recently FDA-approved for above-the-knee interventions, the first-of-its-kind dissection repair device is implanted post-angioplasty to resolve dissections in patients with peripheral arterial disease

    Intact Vascular Announces Tack Endovascular System (6F) Receives FDA Approval

    4/15/19: Intact Vascular reported the U.S. Food and Drug Administration approval for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease.

    Tack Endovascular System® Is Launched in the EU and First Commercial Use in Germany

    “The Tack System provides a much-needed therapeutic option for treating dissections in the superficial femoral or popliteal arteries following balloon angioplasty,” said Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany. “I am very pleased with my experience using the implant, and I am excited to incorporate this technology into my above and below the knee treatment algorithms going forward.”

    Intact Vascular to Sponsor Post-Angioplasty Dissection Symposium and Present an Update on the TOBA II Pivotal Study Results at the 2018 VEITHsymposium

    Tack Endovascular System®, a first-of-its-kind dissection repair device, is designed to preserve vessel integrity and enhance blood flow following balloon angioplasty.

    Intact Vascular Announces Positive One-Year Data from the TOBA II Clinical Trial

    One year results from the TOBA II study were presented in the late-breaking scientific session by William Gray, M.D., System Chief, Division of Cardiovascular Disease at Main Line Health, President, Lankenau Heart Institute and Principal Investigator for the TOBA II trial.

    Intact Vascular Reports Enrollment Completion of the Tack Optimized Balloon Angioplasty III (TOBA III) Clinical Trial

    The TOBA III study is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System® in combination with the Medtronic IN.PACT™ Admiral™ drug-coated balloon in the treatment of peripheral arterial disease in the superficial femoral and popliteal arteries.

    Intact Vascular Announces $20 Million Series C Financing to Fund Company through PMA Approval of the Tack Endovascular System®

    “We continue to be impressed with the extensive clinical program that Intact Vascular is advancing to illustrate the significant clinical benefits that a better solution for dissections can have on angioplasty for peripheral arterial disease and critical limb ischemia,” said Justin Klein, MD, JD, Partner at New Enterprise Associates and member of the Intact Vascular Board of Directors.

    TOBA BTK Trial One-Year Clinical Study Results Published in Catheterization and Cardiovascular Intervention

    This multi-center pilot study focused on collecting data supporting the safety and performance of the Tack Endovascular System® in subjects with Critical Limb Ischemia (CLI) due to vascular disease below the knee.

    FDA Approves 6-Month Primary Endpoint for the Tack Endovascular System® in Below the Knee Disease

    The TOBA II BTK study enrolled its first patient in February, 2017 and is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia

    Intact Vascular Announces Completion of Enrollment in the Tack Optimized Balloon Angioplasty II (TOBA II) Clinical Trial

    The TOBA II trial is a prospective, multi-center, two-arm, non-randomized study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard or drug coated balloon (DCB) angioplasty in the arteries above the knee.

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