Elixir Medical has joined the growing intravascular lithotripsy (IVL) market following the CE marking of its LithiX Hertz Contact system.
The LithiX device employs focal stress contact points to create fractures in calcified portions of vessels. This mechanical method is a different approach to many other IVL systems that use sound waves to break up calcium.
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IVL is used to prepare coronary or peripheral vessels for angioplasty and stenting. Elixir’s system has been approved for calcium fragmentation in the treatment of moderate to severely calcified coronary artery lesions. The first cases with the LithiX device were conducted at hospitals in Italy, France, and Germany.
“LithiX Hertz Contact IVL fulfils that goal as a simple-to-use and versatile option with excellent clinical performance,” said interventional cardiologist Stefano Galli, one of the physicians involved in the first use cases.
Elixir designed its system with multiple metal hemispheres across the surface of a semi-compliant balloon. When the balloon has low inflation pressure, these structures create localised points of contact with calcium and amplification of force to create deep and wide fractures. The US company states that injury to nearby vessel tissue is minimised.
“Energy-based lithotripsy for intravascular use was adapted to deliver effective calcium modification while preventing injury to adjacent non-calcified vessels associated with manual devices. With LithiX, we created the first mechanical IVL platform,” said Elixir’s CEO Motasim Sirhan.
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By GlobalDataApproval was based on results from the PINNACLE I clinical trial. The study, which enrolled 60 patients, demonstrated effective treatment in a broad range of complex calcified lesions.
IVL has become a revenue target for major medical device players. Johnson & Johnson (J&J) brought attention to the space last year when it acquired Shockwave Medical in a $13.1bn deal – still the largest ever deal in the medtech industry to date. Shockwave received a CE marking for its system in 2017. Despite Elixir joining the European market eight years after Shockwave, it has managed to beat out Boston Scientific.
Boston Scientific joined the space earlier this year when it agreed to acquire a remaining stake in IVL specialist Bolt Medical for $664m. In April, Bolt Medical received US Food and Drug Administration (FDA) clearance for its IVL system, though the system is not yet commercially available in Europe. Elixir Medical meanwhile has not revealed plans for a US market entry.
