Elixir Medical’s LithiX Hertz Contact IVL System Approved and Launched in Europe

April 10, 2025—Elixir Medical announced European Union Medical Device Regulation—EU MDR—CE Mark approval of its LithiX Hertz Contact (HC) intravascular lithotripsy system (IVL) and the launch of the device in Europe.

According to the company, the transcatheter LithiX HC IVL system is composed of multiple low-profile metal hemispheres uniformly distributed and integrated across the surface of a semicompliant balloon.

Elixir Medical stated that the system is designed so that under low balloon inflation pressure, the hemispheres create highly localized points of contact with calcium and amplification of force, creating deep and wide fractures based on Hertz Contact Stress mechanics, while minimizing vessel injury when in contact with soft noncalcified vessel tissue. LithiX’s lithotripsy mechanism of action to create calcium fractures is based on the Hertz Contact Stress principle and does not require an external energy source or capital equipment, noted the press release.

The first commercial procedures with the device were completed by Stefano Galli, MD, an interventional cardiologist at Centro Cardiologico Monzino in Milan, Italy; Professor Eric Van Belle, MD, Head of the Interventional Cardiology Department at Lille University Hospital in Lille, France; and Professor Nikos Werner, MD, from Hospital Barmherzigen Bruder Trier in Trier, Germany.

The company noted that in October 2024, it announced the 6-month data from the prospective, multicenter, single-arm PINNACLE I clinical study evaluating the safety, effectiveness, and performance of the LithiX HC-IVL system for the treatment of calcified lesions. The trial is composed of 60 patients enrolled across seven sites in Belgium and the Netherlands. An imaging subset includes 32 patients who underwent intravascular imaging assessment by optical coherence tomography (OCT).

The company reported that the PINNACLE I data demonstrated the LithiX HC-IVL’s mechanism of action with sustained clinical outcomes. Additionally, the OCT imaging substudy showed effective treatment in a broad range of complex calcified lesions, including concentric and eccentric calcium and lesions with calcium nodules. Stent expansion at the Minimum Stent Area location was 101.38% and 93.95% in eccentric and concentric lesions, respectively. In lesions with calcified nodules, stent expansion at maximum calcium site was 102.81%.

The LithiX HC-IVL system is not available for sale in the United States, advised Elixir Medical.