April 10, 2025

Novel IVL technology designed to deliver calcium fragmentation for treatment of moderate to severely calcified coronary artery lesions without requiring an energy source.

IVL technology expands company’s innovative product portfolio.

MILPITAS, Calif., April 10, 2025 (GLOBE NEWSWIRE) -- Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced EU MDR CE Mark approval and commercial launch of its LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL) in Europe. The first cases were completed by Stefano Galli, MD, Interventional Cardiologist at Centro Cardiologico Monzino in Milan, Italy; Professor Eric Van Belle, MD, Head of the Interventional Cardiology Department, Lille University Hospital, Lille, France; and Professor Nikos Werner, MD, Hospital Barmherzigen Bruder Trier, Trier, Germany.

LithiX™ lithotripsy mechanism of action to create calcium fractures is based on the Hertz Contact Stress principle and does not require an external energy source or capital equipment, delivering the expected performance of IVL with additional versatility to treat complex calcified lesions based on the unique design.

“Lithotripsy, introduced in urology a few decades ago, has evolved to encompass mechanical and energy-based mechanisms of action to fragment calcium deposits while minimizing injury to soft tissue. Energy-based lithotripsy for intravascular use was adapted to deliver effective calcium modification while preventing injury to adjacent non-calcified vessel associated with manual devices,” said Motasim Sirhan, CEO of Elixir Medical. “With LithiX™, we created the first mechanical IVL platform capable of treating broad calcified lesion morphologies with great final outcomes, while minimizing injury to adjacent non-calcified vessel.”

LithiX™ Hertz Contact IVL System is a transcatheter device comprised of multiple low-profile metal hemispheres uniformly distributed and integrated across the surface of a semi-compliant balloon. Under low balloon inflation pressure, the hemispheres create highly localized points of contact with calcium and amplification of force to create deep and wide fractures based on Hertz Contact Stress mechanics, while minimizing vessel injury when in contact with soft non-calcified vessel tissue.

“Optimal calcium modification is very important in achieving good PCI outcomes, and LithiX Hertz Contact IVL fulfills that goal as a simple-to-use and versatile option with excellent clinical performance,” said Stefano Galli, MD, Interventional Cardiologist at Centro Cardiologico Monzino in Milan, Italy.

With this unique mechanism of action, LithiX™ HC-IVL is designed to enhance and expand calcium treatment with an optimized procedure workflow in the catheterization lab, positively impacting percutaneous coronary intervention (PCI) treatment.

“We are excited to adopt LithiX™ in our everyday practice as a very deliverable tool designed to safely modify calcified lesions that is easy to use with high degree of precision and control,” said Nikos Werner, MD, Hospital Barmherzigen Bruder Trier, Trier, Germany.

“In our first cases, we have seen confirmation of the recent PINNACLE study outcomes with LithiX HC-IVL in treating calcified coronary lesions with a great procedural result in eccentric and concentric calcium,” added Professor Eric Van Belle, MD, Head of the Interventional Cardiology Department, Lille University Hospital, Lille, France.

The company recently announced six-month data from the PINNACLE I study showcasing LithiX™ HC-IVL’s unique mechanism of action with sustained clinical outcomes. An intravascular imaging sub-study using optical coherence tomography (OCT) demonstrated effective treatment in a broad range of complex calcified lesions, including concentric and eccentric calcium and lesions with calcium nodules. Stent expansion at the Minimum Stent Area (MSA) location was 101.38%, 93.95% in eccentric and concentric lesions respectively. In lesions with calcified nodules, stent expansion at maximum calcium site was 102.81%.

​​About the PINNACLE I Trial

PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact Intravascular Lithotripsy (HC-IVL) System for the treatment of calcified lesions. The trial includes 60 patients across seven sites in Belgium and the Netherlands. An imaging subset of 32 patients underwent intravascular imaging assessment by OCT.

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. Visit us at www.elixirmedical.com and on LinkedIn and X.

The LithiX HC-IVL system is CE Mark approved. Not available for sale in the United States.