Elixir Medical’s DynamX Sirolimus-Eluting Coronary Bioadaptor System Granted FDA Breakthrough Device Designation for the Treatment of Symptomatic Ischemic Heart Disease
Tag: Elixir Medical
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
PARIS–(BUSINESS WIRE)–Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced that the PINNACLE I study evaluating the safety and performance of its LithiX™ Hertz Contact Intravascular Lithotripsy System (IVL) for treatment of moderate to severely calcified coronary artery lesions met its primary safety and […]
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
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive technologies to treat cardiovascular and peripheral disease, today announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The DynamX Bioadaptor platform is a medical technology d
TCT 2023: Six-Month Clinical Data from DESyne® BDS Plus Randomized Controlled Trial (RCT) Support Safety and Effectiveness of World’s First Site-Specific Antithrombotic Drug Therapy
SAN FRANCISCO–(BUSINESS WIRE)–Elixir Medical, a developer of novel cardiovascular technologies, today announced positive six-month clinical data from the DESyne BDS Plus Randomized Controlled Trial (RCT) evaluating DESyne BDS Plus, the world’s first triple drug-eluting coronary implant with site-specific delivery of antithrombotic drugs versus a second-generation, durable polymer drug-eluting stent (DES). The study met its primary endpoint of target lesion failure (TLF) with no TLF events rep
Elixir Medical To Present Randomized Clinical Dataset Featuring World’s First Triple Drug-Eluting Coronary Implant Eluting Two Anticoagulants and Sirolimus at TCT 2023
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative cardiovascular technologies, 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. The data […]
Elixir Medical Completes Submission of DynamX Coronary Bioadaptor System to Japan’s PMDA Agency for Regulatory Approval
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive cardiovascular technologies, announced submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) for the approval of the DynamX® Coronary Bioadaptor System for the treatment of coronary artery disease (CAD). DynamX coronary bioadaptor was developed to overcome the limitations of drug-eluting stents (DES) and […]
Elixir Medical Completes Enrollment of INFINITY-SWEDEHEART Clinical Trial
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of breakthrough cardiovascular technologies, 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). DynamX Bioadaptor is the […]
Elixir Medical To Announce Late-Breaking Clinical Data at EuroPCR 2023 Session Featuring World’s First Transforming Coronary Artery Implant Designed to Restore Vessel Physiology and Function
– 12-month clinical and imaging data from first multicenter, international, randomized controlled trial of DynamX® Bioadaptor vs. Resolute OnyxTM to be presented Wednesday, May 17 – – Elixir Medical’s DynamX Bioadaptor goes beyond traditional caged tube drug-eluting stents (DES), or the promise of bioresorbable scaffolds (BRS), and is designed to restore flow, […]
Elixir Medical Expands Leadership Team With Addition of Alexey Nepogodiev as Executive Vice President, Global Marketing
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced it has appointed Alexey (Alex) Nepogodiev as Executive Vice President, Global Marketing. Alex possesses more than 20 years of leadership experience in successfully developing new markets and therapies in interventional cardiology, structural heart, and endovascular businesses worldwide. […]
DynamX Bioadaptor Restores Rotational Motion and Vessel Stress Reduction in New Study
Paper Published in Cardiovascular Revascularization Medicine Shows Innovative Coronary Artery Implant is Capable of Moving with Vessel, Unlike Conventional Stents MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced print publication of a study in the latest issue of Cardiovascular Revascularization Medicine that showed that the DynamX™ […]
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