Abstract
Background: Intravascular lithotripsy (IVL) has emerged as a safe and effective modality for treating severely calcified coronary lesions. While the Shockwave™ system is well-established, clinical data on newer IVL platforms such as the Shunmei ShockFast™ system remain limited. Objectives: To evaluate the safety, feasibility, and procedural outcomes of the ShockFast IVL device in patients with heavily calcified de novo coronary artery disease. Methods: We conducted a prospective, single-center case series of 16 patients undergoing percutaneous coronary intervention (PCI) with the ShockFast IVL system between June and December 2025. Inclusion required angiographic or optical coherence tomography (OCT) evidence of severe coronary calcification. The primary efficacy endpoint was acute procedural success and absence of in-hospital MACE. Secondary endpoints included, among others, device deliverability, presence of calcium fracture and post-stent expansion metrics. Results: All patients underwent successful lithotripsy delivery with the ShockFast IVL system. Acute procedural success was 100%, with no intraprocedural complications, abrupt closure, or in-hospital MACE. OCT was performed in 50% of cases and demonstrated calcium fractures in all imaged lesions, with ≥2 fractures in 63% of cases. Median stent expansion was 90% [IQR 9], with no major malapposition or edge dissections. Quantitative coronary analysis showed a median acute lumen gain of 1.86 mm [0.62]. Conclusions: The ShockFast IVL system showed excellent safety and procedural performance in this first-in-center experience. Outcomes were encouraging and consistent with those reported in early-stage studies of other IVL platforms. These findings support the clinical feasibility of ShockFast as a novel tool for calcium modification in complex PCI.