Elixir Medical’s DynamX Sirolimus-Eluting Coronary Bioadaptor System Granted FDA Breakthrough Device Designation for the Treatment of Symptomatic Ischemic Heart Disease
The designation recognizes the novelty of the technology and the potential to provide a more effective treatment option for patients with coronary artery disease, specifically to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease.
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
Hertz Contact intravascular lithotripsy, as validated by PINNACLE I data, offers an effective and safe treatment option for patients with short procedure time, simple learning curve, and utility in treatment of a broad range of moderate to severe calcified lesions.
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
Clinical research comparing DESyne BDS Plus, the world’s first triple drug-eluting coronary implant with site-specific antithrombotic therapeutic (TRx) coating versus a contemporary drug-eluting stent (DES), results demonstrated a statistically significant lower TLF rate with DESyne BDS Plus than DES.
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
Clinical results show statistically significant benefit with DynamX bioadaptor over Resolute Onyx at two years, including a 65% reduction in TLF rate (1.9% versus 5.5%; p=0.046), driven by low adverse events across all components of the composite endpoint with DynamX compared to DES.
Elixir Medical To Announce Data from Three Platforms Designed to Transform Cardiovascular Disease Treatment at EuroPCR 2024, Including Two Late-Breakers
Researchers will present results from the BIOADAPTOR RCT, studying DynamX® bioadaptor vs. DES; PINNACLE I, which reviews the novel LithiX Hertz Contact Intravascular Lithotripsy technology; and one-year results from DESyne BDS Plus RCT, a study of the novel TRx site-specific antithrombotic therapeutic.
King Fahad Armed Forces Hospital Begins Trial of New Bioadaptive Angioplasty Procedure for Heart Disease Treatment
King Fahad Armed Forces Hospital is the first in the Kingdom of Saudi Arabia to begin clinical research and offer a new type of angioplasty procedure with the DynamX® Bioadaptor, a novel coronary implant designed to restore vessel function in patients with coronary artery disease (CAD).
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.
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
Elixir Medical announced positive six-month clinical data from the DESyne BDS Plus Randomized Controlled Trial (RCT) evaluating DESyne BDS Plus versus a second-generation, durable polymer drug-eluting stent (DES).
Randomized Clinical Dataset Featuring World’s First Triple Drug-Eluting Coronary Implant Eluting Two Anticoagulants and Sirolimus At TCT 2023
Elixir Medical 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
Elixir Medical Completes Submission of DynamX Coronary Bioadaptor System to Japan’s PMDA Agency for Regulatory Approval
“Our submission for approval in Japan is an exciting milestone for the company and industry,” said Motasim Sirhan, CEO of Elixir Medical.