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

MY-IVL study enrolled 102 real world complex patients (130 lesions) with core lab adjudicated intravascular imaging analysis

MILPITAS, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) --  Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, announced results from the MY-IVL Study at the Transcatheter Cardiovascular Therapeutics (TCT) Conference 2025 in San Francisco. The data showed excellent clinical outcomes for LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL) in the treatment of severely calcified coronary lesions among complex and high-risk percutaneous coronary intervention (PCI) patients.

The MY-IVL Study evaluated 102 consecutive all-comer patients with notable severe calcified coronary artery disease treated with LithiX HC-IVL between April and September 2025 at Cardiac Vascular Sentral Kuala Lumpur Hospital (CVSKL), Malaysia’s first and leading private heart and vascular center. Angiographic and intravascular imaging from all patients was analyzed and adjudicated by an independent core lab MedStar Cardiovascular Research Network Core Laboratory at Washington Hospital Center, Washington, DC. The study included a broad range of clinically complex patients with multiple comorbidities clinically presenting with stable angina or acute coronary syndrome, including patients in cardiogenic shock, reflecting the device’s use and performance in everyday practice.

Patient and lesion characteristics include:

• 102 patients with 130 lesions treated
• Average lesion length was 19.72 ± 14.09 mm and more than 30% of lesions were longer than 20 mm with an average length of 35.7 mm
• 88% of lesions had severe calcification
• Calcification in 41% of lesions was eccentric (arc of ≤ 270°), including 20% of lesions with an arc ≤ 180°
• 94.6% of lesions were Class B2/C by American Heart Association (AHA) classification, which is associated with almost a two-fold risk of target lesion failure events within 30 days as compared to noncomplex lesions ¹

Key clinical and procedural findings include:

• 96.1% of freedom from MACE at 30 days (Primary Safety Endpoint)
• Angiographic diameter stenosis of < 30% without intra-procedural MACE was achieved in 96.3% of patients following DES treatment
• There were no LithiX HC-IVL device-related angiographic procedural complications

Key core lab adjudicated intravascular imaging results:

• Post procedure mean minimum stent area (MSA) was 6.89 mm², exceeding the powered performance goal (PG) of 4.9 mm² (p < 0.0001), derived from previous IVL and rotational atherectomy device studies (Co-Primary Effectiveness Endpoint)
• Mean stent expansion of > 100% was achieved in all lesion morphologies, including concentric and eccentric calcification

“LithiX represents an important advancement in PCI. In our experience, its notable advantages include versatility and high treatment effect in modifying the most complex calcified lesions using a simpler procedure flow, particularly in this study with only a single device used per procedure, including multiple and long lesions,” said Dr. Tamil Selvan Muthusamy, Consultant Cardiologist at CVSKL and Co-Principal Investigator of the MY-IVL Study.

The LithiX HC-IVL System is an advanced intravascular lithotripsy technology designed to optimize device expansion in calcified coronary artery blockages during a PCI procedure. Unlike energy-based systems dependent on an external energy generator, LithiX device is a highly deliverable mechanical lithotripsy device using a balloon with integrated low-profile metallic hemispheres to create focal pressure amplification based on Hertz Contact Stress theory.

“Our study demonstrates excellent calcium modification potential of this novel Hertz Contact Lithotripsy technology, with MSA above 100% in all treated lesions, even those with less than 180% degree arc of calcium, which, based on our experience, are often difficult to treat with existing calcium modification devices,” added Dr. Rosli Mohd Ali, Consultant Cardiologist at CVSKL and Co-Principal Investigator of the MY-IVL Study.

The Hertz Contact Lithotripsy hemispheres work selectively on calcium within the lesion, breaking and fragmenting the hardened plaque under low balloon inflation pressure. The hemispheres (27 to 45 depending on device size) are designed to create highly localized points of amplified force to create deep and wide fractures at the multiple points of contact with calcium while being atraumatic to the adjacent non-calcified vessel due to the tissue’s elasticity.

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 and is not available in the United States.

Media Contact

Richard Laermer, RLM PR, elixir@rlmpr.com  (212) 741-5106 X 216

¹ Konigstein M et al. J Am Heart Assoc. 2022;11:e025275. DOI: 10.1161/JAHA.121.025275