Novel device shows promise for the treatment of calcified coronary artery lesions.The PINNACLE-I trial shows the feasibility, safety, and efficacy of LithiX, a novel Hertz contact intravascular lithotripsy (HC-IVL) device, for the treatment of calcified coronary artery lesions.
“[LithiX] uses the HC mechanism to fragment coronary calcium without an external energy source,” the investigators said. “[Our findings show] a reassuring safety and performance profile, with high procedural success, calcium fractures in >90 percent of lesions, and optimal stent expansion across a broad range of calcium morphologies.”
The primary safety and effectiveness endpoint was met: All but one achieved in-hospital clinical success, defined as residual stenosis <50 percent after final treatment (± stenting) with no evidence of in-hospital major adverse cardiovascular event (MACE; composite of cardiovascular [CV] death, MI, target vessel revascularization). MACE rate up to 30 days post-procedure was an additional primary safety endpoint.
All patients achieved angiographic success with residual diameter stenosis <30 percent, with only one case of target lesion failure (TLF; periprocedural non-Q-wave MI) at 30 days. There were no CV deaths, definite or probable stent thromboses, unanticipated events, or additional TLF events up to 6 months. [EuroIntervention 2026;22:255-264]
The low TLF rates reflect the device’s reassuring safety profile, due to its novel design that enables exponential force amplification through discrete contact points that selectively target calcium while minimizing injury to the adjacent noncalcified vessel tissue, and its low-profile, trackable system, the researchers noted.
Stent delivery success rate was 100 percent, as was angiographic success post-procedure.
Using optical coherence tomography (OCT), calcium fractures post-HC-IVL were identified in 90.6 percent of lesions (mean fracture depth 0.81 mm). “The extension of calcium fractures into the medial layer provides evidence of the device’s effective mechanism of action,” they said.
Stent expansion at the minimum lumen area, maximum calcium, and minimum stent area (MSA) sites was 100.9, 103.4, and 96.7 percent, respectively. The researchers said that these results are particularly notable, considering the recommended 80-percent expansion at the MSA site. [Eur Heart J 2018;39:3281-3300] “Importantly, these were consistent regardless of the extent of calcification or presence of calcium nodules, which remain a challenge with existing calcium modification options.”
Calcified coronary lesions remain a key challenge in percutaneous coronary intervention (PCI), as they impede stent expansion, increase malapposition risk, and are tied to increased complication rates and poor outcomes. [J Am Coll Cardiol 2014;63:1845-1854; Eur Heart J Suppl 2023;25:C68-C73; Eur Heart J 2018;39:3281-3300] Current energy-based IVL technologies require an external energy source and capital equipment for amplified stress generation. [Can J Cardiol 2024;40:1657-1667; Circulation 2019;139:834-836]
“The LithiX HC-IVL System is the first mechanical IVL platform that does not need an external energy source or capital equipment, offering an efficient procedure workflow and a potentially faster learning curve. It is based on the HC theory, which explains how discrete stress develops when a spherical surface deforms a planar object,” the researchers explained.
The study enrolled 60 patients (mean age 72.1 years; 82 percent with chronic coronary syndrome) requiring PCI for up to two de novo coronary artery lesions (total 63 lesions) with moderate-to-severe calcification. The median procedure time was 59.5 min. Thirty-two participants were included in the OCT substudy.
The main observations from PINNACLE-I were effective calcium modification, optimized % stent expansion and MSA irrespective of calcium morphology or distribution, extremely low rates of MACE and other adverse angiographic or clinical outcomes, and short procedure times, the researchers said.
They called for larger, longer-term studies across more diverse patient populations to validate the results.