Elixir Medical Elixir Medical , a developer of technologies to treat cardiovascular disease, has announced positive six-month data from the PINNACLE I study evaluating the safety and performance of its LithiX Hertz Contact (HC) Intravascular Lithotripsy System (IVL) for the treatment of moderate to severely calcified coronary artery lesions demonstrating safety and efficacy. The data was presented at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF). “The cardiology community has long sought solutions that can better treat patients with calcified lesions to achieve optimal PCI outcomes,” said Johan Bennett, M.
D., study principal investigator and director of CTO/CHIP program at the University Hospital Leuven in Leuven, Belgium. “The six-month PINNACLE I data are a strong validation of LithiX IVL’s mechanism of action that can safely fragment calcium across a range of complex morphologies without trauma to the soft tissue and can be easily integrated into standard PCI procedure workflow without the need for an energy source.
” The company says the LithiX data results demonstrate: 98.3% clinical success (primary effectiveness and safety endpoint) with 100% angiographic success across a range of moderate to severe calcium morphologies < 30% residual diameter stenosis was achieved in 100% of the lesions No procedural angiographic complications, including no severe dissections, perforation, or a.
