Elixir Medical received CE mark for its LithiX hertz contact (HC) intravascular lithotripsy (IVL) system.
The Milpitas, California–based company kicked off its commercial launch for the IVL system in Europe following receipt of CE mark. Dr. Stefano Galli (Centro Cardiologico Monzino in Milan), Dr. Eric Van Belle (Lille University Hospital, Lille, France) and Dr. Nikos Werner (Hospital Barmherzigen Bruder Trier, Trier, Germany) completed the first cases with the system.
Related: Surmodics launches Pounce XL thrombectomy system
With this launch, Elixir joins the hot IVL space that features leader Shockwave Medical, part of Johnson & Johnson following a $13.3 billion acquisition in 2024. Other companies, such as FastWave Medical, Vantis Vascular and AVS, are making waves in IVL, too. Boston Scientific recently joined the fray with its acquisition of Bolt Medical, too.
LithiX utilizes the lithotripsy mechanism of action to create calcium fractures, based on the Hertz Contact Stress principle. It doesn’t require an external energy source or capital equipment. This enables the performance of IVL with additional versatility to treat complex calcified lesions based on its unique design.
The transcatheter device features 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. Along with the amplification of force, this creates deep and wide fractures while minimizing vessel injury when contacting soft, non-calcified vessel tissue.
Elixir says its unique method for IVL could enhance and expand calcium treatment with an optimized procedure workflow. Six-month PINNACLE I study data from 60 subjects showed sustained clinical outcomes with the LithiX HC-IVL system.
“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.”
