LithiX™ HC-IVL is a novel lithotripsy system designed to facilitate treatment of heart disease exacerbated by the presence of calcium within coronary artery plaques
New clinical study to be presented at Transcatheter Cardiovascular Therapeutics (TCT) Conference 2025 in San Francisco, CA, on October 27, 2025
MILPITAS, Calif. , Oct. 01, 2025 (GLOBE NEWSWIRE) -- Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced key milestone and full market release of its LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL), following the announcement of CE Mark approval earlier this year.
The LithiX HC-IVL System is an advanced intravascular lithotripsy technology designed to optimize 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 localized 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, the LithiX HC-IVL technology has achieved key milestones highlighted by positive market reception and physician adoption:
- Over 400 patients have been treated with LithiX HC-IVL across 16 countries in Europe and Asia
- LithiX has been evaluated and is being adopted in over 90 leading hospitals
During the initial phase of the LithiX HC-IVL launch, physicians consistently highlighted several important performance attributes:
- High deliverability of the device allowing for treatment of tortuous coronary anatomies
- Success in treating a broad range of calcified plaque morphologies such as eccentric, nodular and concentric calcium, enabling excellent final lesion expansion
- Versatility and streamlined workflow translating to low resource utilization
"LithiX quickly became our primary calcium modification tool. As a high-volume center, 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 Dr. 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 in San Francisco, CA, on October 27 in the Innovation Session. TCT is the world’s leading educational forum specializing in interventional cardiovascular medicine and clinical science.
The successful completion of the limited market release enables Elixir Medical to continue expansion of LithiX HC-IVL into global markets.
About Elixir Medical
Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025 and Fierce Medtech's 2025 Fierce 15 list. Visit us at www.elixirmedical.com and on LinkedIn and X.
The LithiX HC-IVL System is CE Mark approved. Not available in the United States.
Media Contact
Richard Laermer
RLM PR
elixir@rlmpr.com
(212) 741-5106 X 216
