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369,926 Results for "elixir medical".
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FDA
Elixir Medical’s DynamX Sirolimus-Eluting Coronary Bioadaptor System Granted FDA Breakthrough Device Designation for the Treatment of Symptomatic Ischemic Heart Disease
Elixir Medical’s DynamX Sirolimus-Eluting Coronary Bioadaptor System Granted FDA Breakthrough Device Designation for the Treatment of Symptomatic Ischemic Heart Disease.
June 18, 2024
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4 min read
Biotech Bay
Elixir Medical To Announce Data from Three Platforms Designed to Transform Cardiovascular Disease Treatment at EuroPCR 2024, Including Two Late-Breakers
Elixir Medical To Announce Data from Three Platforms Designed to Transform Cardiovascular Disease Treatment at EuroPCR 2024, Including Two Late-Breakers.
April 30, 2024
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7 min read
EuroPCR 2024: Late-Breaking Data Demonstrate Significant Clinical Advantage of Elixir Medical’s DynamX Bioadaptor Over Standard of Care Drug-Eluting Stent at Two Years
Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, announced two-year results from the BIOADAPTOR Randomized Controlled Trial, comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent from 34 centers in Japan, Europe, and New Zealand.
May 14, 2024
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5 min read
EuroPCR 2024: Primary Outcomes from PINNACLE I Clinical Trial Establish Safety and Effectiveness of Elixir Medical’s Hertz Contact Intravascular Lithotripsy System for Calcium Fragmentation in Moderate to Severe Calcified Coronary Artery Lesions
Elixir Medical announced that the PINNACLE I study evaluating the safety and performance of its LithiX™ Hertz Contact Intravascular Lithotripsy System for treatment of moderate to severely calcified coronary artery lesions met its primary safety and effectiveness endpoint of clinical success.
May 16, 2024
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6 min read
EuroPCR 2024: Elixir Medical’s Late-Breaking 12-Month Data Demonstrate Significant Improvement in Safety and Effectiveness of World’s First Site-Specific Antithrombotic Therapeutic Compared to DES
Elixir Medical announced significant positive 12-month clinical data from the DESyne BDS Plus Randomized Controlled Trial evaluating DESyne BDS Plus, the world’s first triple drug-eluting coronary implant with site-specific antithrombotic therapeutic coating versus a contemporary, durable polymer drug-eluting stent.
May 14, 2024
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6 min read
Press Releases
Elixir Medical’s DynamX Sirolimus-Eluting coronary bioadaptor system receives US FDA Breakthrough Device Designation
July 29, 2024
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4 min read
FDA
Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease
Elixir Medical today announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX ® BTK System.
March 21, 2024
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4 min read
Biotech Bay
Elixir Medical Completes Submission of DynamX Coronary Bioadaptor System to Japan’s PMDA Agency for Regulatory Approval
Elixir Medical, a developer of disruptive cardiovascular technologies, announced submission to Japan’s Pharmaceutical and Medical Device Agency for the approval of the DynamX® Coronary Bioadaptor System for the treatment of coronary artery disease.
October 4, 2023
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4 min read
Biotech Bay
Elixir Medical Completes Enrollment of INFINITY-SWEDEHEART Clinical Trial
Elixir Medical today announced enrollment completion in INFINITY-SWEDEHEART, a prospective, multicenter, single-blind, randomized clinical trial of the DynamX ® Coronary Bioadaptor System, the first metallic coronary artery implant that adapts to vessel physiology versus the Resolute Onyx™ Drug-Eluting Stent (DES).
July 13, 2023
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4 min read
Biotech Bay
Elixir Medical To Present Randomized Clinical Dataset Featuring World’s First Triple Drug-Eluting Coronary Implant Eluting Two Anticoagulants and Sirolimus at TCT 2023
Elixir Medical announced it will present primary endpoint and 6-month data from its DESyne BDS Plus Randomized Clinical Trial (RCT), a prospective, multicenter, single-blind study, as part of The Innovation Program at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.
October 5, 2023
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5 min read
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