Elixir’s LithiX HC IVL System Data Presented From Real-World Study of Calcified Coronary Lesion Treatment

November 6, 2025—Elixir Medical announced clinical outcomes from the MY-IVL study of the company’s LithiX Hertz Contact (HC) intravascular lithotripsy system (IVL) in the real-world treatment of severely calcified coronary lesions among complex and high-risk percutaneous coronary intervention patients. The results were presented at the TCT scientific symposium.

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), a private heart and vascular center in Kuala Lumpur, Malaysia.

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; 130 lesions were treated.

The company reported the following key clinical and procedural findings:

• 96.1% of freedom from MACE at 30 days (the primary safety endpoint).
• Angiographic diameter stenosis of < 30% without intraprocedural MACE was achieved in 96.3% of patients after DES treatment.
• No LithiX HC-IVL device-related angiographic procedural complications

The key core lab–adjudicated intravascular imaging results included the following:

• Postprocedure mean minimum stent area was 6.89 mm². This exceeded the powered performance goal of 4.9 mm² (P < .0001), which was derived from previous IVL and rotational atherectomy device studies. This was the coprimary effectiveness endpoint.
• Mean stent expansion > 100% was achieved in all lesion morphologies, including concentric and eccentric calcification.

Tamil Selvan Muthusamy, MBBS, and Rosli Mohd Ali, MBBS, who are consultant cardiologists at CVSKL, serve as Coprincipal Investigators of the MY-IVL study.

Elixir Medical recently announced the full market release of its LithiX HC IVL system, which received European CE Mark approval in April 2025.