Elixir Medical announced the full market release of its LithiX intravascular lithotripsy (IVL) system in Europe.
The Milpitas, California–based company kicked off its initial rollout for the IVL system in Europe following CE mark in April. Now, it has fully launched the advanced hertz contact (HC)-IVL system in the region.
Elixir designed LithiX to optimize device expansion in calcified coronary artery blockages during an angioplasty procedure. It 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.
Following CE mark and the limited rollout, Elixir reports more than 400 patients treated with LithiX HC-IVL across 16 countries in Europe and Asia. More than 90 hospitals have evaluated and adopted the system. The company says the successful limited launch enables it to continue expanding the IVL system into global markets.
The IVL space continues to heat up with Johnson & Johnson acquiring Shockwave Medical, a leader in IVL, for $13 billion last year.
Other companies, such as AVS, FastWave and Vantis Vascular are making waves in IVL, too. Boston Scientific recently joined the fray with its acquisition of Bolt Medical, too. Abbott is making its own IVL play, too, advancing its own system.
