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Elixir Medical’s DynamX Sirolimus-Eluting Coronary Bioadaptor System Granted FDA Breakthrough Device Designation for the Treatment of Symptomatic Ischemic Heart Disease.

Elixir Medical To Announce Data from Three Platforms Designed to Transform Cardiovascular Disease Treatment at EuroPCR 2024, Including Two Late-Breakers.

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.

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.

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.

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.

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.

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).

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.