The Latest Cardiac and Vascular News
WASHINGTON–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced positive six-month data from the PINNACLE I study evaluating the safety and performance of its LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL) for the treatment […]
—Largest randomized data set to date on bioadaptor, with a complex patient population of 2,400 compared to a DES— —Primary endpoint of target lesion failure (TLF) non-inferiority at twelve months was met with a low event rate for DynamX despite […]
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced it will present one-year clinical outcomes from the 2,400 patient INFINITY-SWEDEHEART Randomized Clinical Trial (RCT), a prospective, multi-center, single-blind, clinical trial comparing the drug-eluting DynamX […]
Elixir Medical’s DynamX Sirolimus-Eluting Coronary Bioadaptor System Granted FDA Breakthrough Device Designation for the Treatment of Symptomatic Ischemic Heart Disease
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 […]
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
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
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 […]
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 […]
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 […]
