Elixir Medical Announces Full Commercial Launch of LithiX: The First Passive Intravascular Lithotripsy Balloon

Oct 01, 2025 22:15 CST Updated 22:15

Elixir Medical

Medical Device R&D and Manufacturing Company

Elixir MedicalAnnouncementItsContact (HC) Intravascular Shock Wave---LithiXOfficially and fully launched, this is followingAnother milestone after receiving CE approval at the beginning of the year. SinceLithiXSince receiving CE approval, it has beenEurasia 16The country has implemented treatment for more than 400 patients.

Expert ReviewPrice

"LithiX has rapidly become our preferred tool for calcium modification. As a high-volume surgical center, we value its efficiency and versatility in handling the most complex calcified lesions in advanced heart disease patients, while achieving clinical cost-effectiveness by reducing the use of additional calcium modification devices and simplifying operational procedures."

---Tamil Selvan Muthusamy Sentral Kuala Lumpur (CVSKL) Hospital

LithiXIt is an advanced intravascular lithotripsy technology designed to optimize the device expansion effect on calcified occlusive lesions during percutaneous coronary intervention. Unlike traditional IVL,LithiXWith excellent deliverability, its integrated low-profile metal hemisphere can generate a focused pressure amplification effect based on the Hertzian contact stress principle.

LithiXCapable of selectively targeting calcified tissue within the target lesion, it can fragment hardened plaques at low balloon pressures. By creating multiple highly localized contact force points,LithiXCan produce deep and wide fissures while avoiding damage to adjacent non-calcified vascular tissue.

LithiX

LithiXIt is a passive IVL balloon catheter, which integrates multiple low-profile metal hemispheres evenly on the surface of a semi-compliant balloon. At low balloon inflation pressure, these hemispheres interact with calcium.The formation of highly localized contact points in the tissue. Through the mechanical amplification effect,LithiXCan create deep and wide calcified cracks while minimizing damage to soft non-calcified vascular tissue.

LithiX Technology Principle

LithiXThe mechanism of lithotripsy is based onHertz Contact Stress Principle, without the need for external energy or large equipment, achieves the expected performance of IVL through unique design while possessing multifunctionality for treating complex calcified lesions. It creates deep and wide fractures in calcified plaques via focal stress while minimizing damage to non-calcified vascular tissue.

LithiX Clinical Study

Announced at last year's TCT conferenceLithiX Six-Month Clinical Study:

98.3% Clinical Success Rate(Primary Efficacy and Safety Endpoints),100% Angiography Success RateCovering various types of moderate to severe calcification patterns
100% LesionAchieve <30% residual diameter stenosis
Zero Intraoperative Angiography Complications, including no severe dissection, perforation, or acute occlusion after stenting
Excellent Safety: Only 1 case of perioperative non-Q-wave myocardial infarction, 6-month target lesion failure rate1.7%

Subgroup Study of Intravascular Imaging
Subgroup analysis via optical coherence tomography (OCT) accurately evaluated the fragmentation efficacy of LithiX on different complex calcified morphologies:

Eccentric Lesion Group(Maximum continuous calcification arc 184.38±56.42 degrees, 33.3% with calcified nodules):

84.6% of lesions exhibited calcification rupture, 61.5% of lesions had ≥2 ruptures

Average Rupture Depth0.76±0.28 mm, Average Fracture Width0.51±0.23 mm

Maximum Calcification Site Stent Expansion Rate97.86%, Minimum stent area site101.38%

Concentric Lesion Group(Maximum continuous calcification arc 317.47±22.51 degrees, 29.4% with calcified nodules):

94.7% of lesions exhibited calcification rupture, 84.2% of lesions had ≥2 breaks

Average Rupture Depth0.85±0.36 mm, Average Rupture Width0.75±0.29 mm

Maximum Calcification Site Stent Expansion Rate106.58%, Minimum stent area site93.95%

LithiX Demo

Elixir Medical

Elixir MedicalElixir Medical Corporation is a medical device company located in California, USA, developing next-generation platforms for the treatment of coronary and peripheral artery diseases, aiming to restore vascular adaptive remodeling and pulsatile motion capabilities. Its mission is to transform care for patients with heart and vascular diseases through innovation.