Elixir Medical Reports European MDR CE Mark Approval & Launch of LithiX Hertz Contact IVL System
Shots:
- Elixir has reported European MDR CE Mark approval & commercial launch of LithiX Hertz Contact (HC) Intravascular Lithotripsy (IVL) System in EU to improve calcium & percutaneous coronary intervention treatment
- LithiX is a transcatheter device that uses low-profile metal hemispheres on a semi-compliant balloon to apply HC Stress, creating deep & wide fractures while minimizing vessel injury
- Additionally, 6mos. data from PINNACLE I trial (n=60) in Belgium & the Netherlands showed that LithiX effectively treated complex calcified lesions. In OCT-imaged subset (n=32), stent expansion at MSA location was 101.38%, 93.95% & 102.81% in eccentric, concentric & nodular calcium lesions, respectively
Ref: Globenewswire | Image: Elixir
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