Elixir Medical has reported positive data from the PINNACLE I clinical trial evaluating the safety and effectiveness of its catheter system that uses stress to treat calcified coronary artery lesions.
The results, shared at the ongoing EuroPCR 2024 in Paris, France, demonstrated a 98% clinical success rate and 100% angiographic success in achieving optimal stent expansion.
Elixir has designed the system, named LithiX Hertz Contact Intravascular Lithotripsy (IVL) System, to tackle calcified lesions without the need for capital equipment.
Calcified lesions occur when calcium builds up in the plaque in coronary arteries. Elixir states that nearly one-third of percutaneous coronary intervention (PCI) patients present with calcified coronary lesions. Those with moderately to severely calcified lesions represent a major challenge in terms of treatment, with many approaches unsuccessful.
Research indicates that a greater amount of calcium leads to a greater likelihood of stent under-expansion, which is clinically undesirable.
The PINNACLE I clinical trial enrolled 60 patients with calcified lesions across Belgium and the Netherlands. The prospective, single-arm study’s endpoint was optimal stent expansion after final treatment with no in-hospital major adverse cardiovascular event (MACE) through 30 days, but the trial will continue to provide safety and effectiveness data through six months.
The company reported one myocardial infarction during the study, resulting in a 1.7% MACE event rate. In an imaging sub-study, high lesion fracture rates and optimal stent expansions were also recorded.
Elixir’s transcatheter device uses multiple metal hemispheres that create points of focal stress on the lesion via a balloon. Employing the physics principle of Hertz Contact Stress, fragmentation is achieved after force is applied. Elixir states that non-calcified segments of the lesion are mostly unaffected, minimising vessel injury.
Interventional cardiologist at ZNA Cardiovascular Center in Belgium, Dr Stefen Verheye, who was involved in the study, said: “The multitude of clearly visible and deep fractures, which exceeded our expectations, contributed to the optimal and uniform final stent expansion.”
Cardiovascular device giant Shockwave Medical, now part of Johnson & Johnson after a $13.1bn acquisition, launched its new coronary IVL catheter in Europe in May last year. Shockwave’s system uses an electrical discharge to create waves that crack the calcium. Both Shockwave and Elixir have reported success across a broad range of calcium morphologies, including eccentric and nodular calcifications.
