Closely-held Elixir Medical has announced positive results from its PINNACLE I clinical trial evaluating the safety and effectiveness of its novel LithiX Hertz Contact Lithotripsy (IVL) System that uses stress to treat moderate to severely calcified coronary artery lesions.
At the ongoing EuroPCR 2024 in Paris, France, Elixir reported a 98% clinical success rate and 100% angiographic success in achieving optimal stent expansion. One myocardial infarction occurred during the study resulting in a 1.7% MACE event rate. An imaging sub-study recorded high lesion fracture rates and optimal stent expansion.
“The multitude of clearly visible and deep fractures, which exceeded our expectations, contributed to the optimal and uniform final stent expansion,” said Dr. Stefen Verhey, M.D., Ph.D., interventional cardiologist at ZNA Cardiovascular Center, Belgium.
“Ease of use and simple integration of the device into physician’s workflow also helps shorten the learning curve and procedure time, and reduces radiation exposure for the patient which is of significant value in these complex interventions,” he added.
The prospective, non-randomized, single-arm PINNACLE I clinical trial, conducted throughout Belgium and the Netherlands, enrolled 60 patients with calcified lesions. The study’s endpoint was optimal stent expansion after final treatment with no in-hospital major adverse cardiovascular event (MACE) through 30 days. Elixir’s PINNACLE I clinical trial will continue to provide safety and effectiveness data through six months.
According to Elixir, nearly one-third of patients undergoing percutaneous coronary intervention (PCI) have calcified coronary lesions. Calcified lesions form when calcium accumulates in the plaque of coronary arteries. Treating patients with moderate to severe calcification is particularly challenging, as many treatment approaches prove unsuccessful.
Elixir’s LithiX Hertz Contact Intravascular Lithotripsy (IVL) System, is designed to treat calcified lesions without the need for capital equipment. The transcatheter device uses multiple metal hemispheres that create points of focal stress via a balloon, with fragmentation achieved after force is applied. The company maintains that vessel injury is minimalized as non-calcified segments of the lesion are generally unaffected.
‘Elixir’s focal stress system to treat calcified lesions trial results’ was originally reported by GlobalData’s Medical Device Network.
