Elixir Medical has announced full market release of its LithiX Hertz Contact (HC) intravascular lithotripsy (IVL) system, following CE mark approval earlier this year.
The LithiX HC-IVL system is an advanced intravascular lithotripsy technology designed to optimise device expansion in calcified coronary artery blockages during an angioplasty procedure.
Unlike energy-based systems with a more complex workflow requiring additional equipment, the LithiX device is a highly deliverable balloon-based system with integrated low-profile metallic hemispheres to create focal pressure amplification based on Hertz Contact Stress principle.
The Hertz Contact Lithotripsy hemispheres work selectively on calcium within the target lesion, breaking apart and fragmenting the hardened plaque under low balloon inflation pressure. The hemispheres create multiple highly localised points of contact force to create deep and wide fractures while sparing the adjacent non-calcified vessel tissue.
Following CE mark announcement and limited market release in early April, Elixir Medical has announced that over 400 patients have been treated with LithiX HC-IVL across 16 countries in Europe and Asia
“LithiX quickly became our primary calcium modification tool. As a high-volume centre, we value its effectiveness and versatility enabling us to treat the most complex calcified lesions in patients with advanced heart disease, as well as its cost effectiveness in our practice through reduced use of additional calcium modification devices and a simpler procedure flow,” said Tamil Selvan Muthusamy of Cardiac Vascular Sentral Kuala Lumpur (CVSKL) Hospital, Kuala Lumpur, Malaysia.
Additionally, Elixir announced that CVSKL Hospital has conducted an investigator-initiated study of one hundred patients treated with LithiX HC-IVL. The results, including analysis with intravascular imaging, will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference 2025 (25–28 October, San Francisco, USA).
The successful completion of the limited market release enables Elixir Medical to continue expansion of LithiX HC-IVL into global markets, Elixir Medical said in a press release.
