The US Food and Drug Administration (FDA) has granted Abbott an investigational device exemption to evaluate the company’s coronary intravascular lithotripsy (IVL) system in a clinical trial.

Elixir trails J&J’s Shockwave but has outpaced Bolt Medical to the European market with its mechanical IVL system.

The company has said that system, which was cleared by the FDA last September, has demonstrated a similar safety and effectiveness profile compared to Shockwave’s other lithotripsy catheters.

Intravascular Lithotripsy System (IVL) in Europe. The first cases were completed by Stefano Galli, MD, Interventional Cardiologist at Centro Cardiologico Monzino in Milan, Italy; Professor Eric ...

Abbott announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (IVL) System to evaluate the treatment ...

The North-Chicago based company announced today that the U.S. Food & Drug Administration gave investigational device exemption to Abbott's coronary intravascular lithotripsy system. The trial will ...

The intravascular lithotripsy system uses sound pressure waves to break up calcium deposits that are blocking blood flow. Abbott said the device is designed to address the challenges of currently ...

In the eleven months starting from April 2024 to February 2025, around 700 patients have been treated using the ESWL (Extracorporeal Shock Wave Lithotripsy ... of the urinary system, in the ...

Elixir Medical announced today that it received CE mark for its LithiX hertz contact (HC) intravascular lithotripsy (IVL) ...

April 10, 2025 (GLOBE NEWSWIRE) -- Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced EU MDR CE Mark approval and commercial launch of its LithiX™ ...