Hertz contact intravascular lithotripsy for calcified coronary lesions in real-world practice: Primary outcomes of the MY-IVL post-market study

Background Hertz Contact Intravascular Lithotripsy (HC-IVL) is the first mechanical IVL platform designed to fragment coronary calcium, while minimizing injury to adjacent non-calcified vessel tissue and eliminating the need for external energy source or capital equipment. The PINNACLE-I clinical trial has demonstrated the safety and effectiveness of HC-IVL in treating moderate to severe calcific coronary lesions. In the MY-IVL Study, we aim to evaluate the safety and performance of HC-IVL in a real-world population including patients with multivessel disease, left main disease, chronic total occlusions, and in-stent restenosis. Methods This study includes consecutive patients undergoing HC-IVL between April and September 2025 at a single center with an estimated sample size of 100 subjects. All subjects undergo angiographic and intravascular imaging (OCT / IVUS) at baseline, post-HC-IVL, and post-PCI. Primary safety endpoint was 30-day freedom from MACE (cardiovascular death, MI, target vessel revascularization). Co-primary effectiveness endpoints were residual stenosis <30% without intraprocedural MACE and minimum stent area ≥ 4.9 mm 2 by intravascular imaging. All imaging analyses are performed by an independent core laboratory. Results A total of 102 patients with 130 calcified lesions were treated with HC-IVL, with successful device delivery in all cases and a median of one IVL catheter used per procedure. The primary safety endpoint was achieved in 96.1%, with 96.3% of stented lesions demonstrating residual stenosis <30% without intraprocedural MACE. The 30-day MACE rate was 3.9%, with no myocardial infarction, no target vessel revascularization, and no device-related complications. By intravascular imaging, the mean minimum stent area was 6.89 mm 2 and the lower bound of the 95% confidence interval was 6.50 mm 2 , which exceeded the PG of 4.9 mm 2 ( p < 0.0001). Mean stent expansion was 113.7% across a wide spectrum of calcium morphologies including concentric, eccentric, and circumferential arcs up to 360°. Acute angiographic gain averaged 1.75 ± 0.58 mm with a final in-lesion diameter stenosis of 10.7%. Conclusions MY-IVL study demonstrates that the LithiX HC-IVL system provides safe, effective, and efficient calcium modification across diverse calcified lesion morphologies in a high-risk, real-world Asian PCI population, facilitating optimal coronary stent implantation with favorable early clinical outcomes.