Boston Scientific has shared positive pivotal trial results for its SEISMIQ 4CE Coronary intravascular lithotripsy (IVL) catheter in treating calcified coronary artery disease (CAD).
The 420-patient FRACTURE trial (NCT06181240) met its primary safety endpoint with a 93.3% rate of freedom from major adverse cardiac events (MACE), including cardiovascular death and myocardial infarction at 30 days, outpacing the study’s prespecified performance goal of 86.2%.
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Meeting its primary effectiveness endpoint, defined as successful stent delivery with a final residual stenosis of less than 50% and freedom from in-hospital MACE, the trial achieved a 93.7% procedural success rate, also exceeding a prespecified performance goal set at 85.8%.
Patients involved in the FRACTURE trial, which is being conducted under an investigational device exemption (IDE), will be followed for two years post-procedure. The trial’s findings were presented in a late-breaking trial session at the EuroPCR 2026 congress, taking place from 19-22 May in Paris, France.
Janar Sathananthan, chief medical officer, interventional cardiology therapies at Boston Scientific, commented: “The data presented today serves as pivotal evidence to support our regulatory submission for the Seismiq 4CE catheter, which may provide physicians a new, differentiated coronary IVL device option to address severe calcium during the lesion prep phase of complex PCI procedures, potentially improving outcomes for these high-risk patients.”
Seismiq 4CE is designed to prepare hardened, blocked arteries for stent placement by using laser energy that creates acoustic pressure waves to safely fracture calcium within the vessel wall.
Growth in the IVL space
Boston Scientific entered the IVL space via the $664m acquisition of Bolt Medical in January 2025, with Bolt’s peripheral catheter system gaining FDA clearance in March 2025. Boston later rebranded the Bolt technology to Seismiq. Boston’s coronary catheter is compatible with the same console used with its existing peripheral technology.
Johnson & Johnson (J&J) is considered the IVL market leader, courtesy of its subsidiary Shockwave Medical. J&J paid $13.1bn to acquire Shockwave in June 2024, gaining access to several IVL products. However, since this deal, the IVL space has attracted the interest of other industry players.
Stryker gained a foothold in the IVL market with its acquisition of Amplitude Vascular Systems (AVS), agreed in April 2026. Bolstering the medtech giant’s vascular care portfolio with AVS’s Pulse IVL, the system delivers pressurised sound waves through an IVL balloon catheter to break up calcium deposits associated with calcified PAD to increase arterial patency. The company secured an IDE from the FDA in June 2024 to evaluate the system in a pivotal trial.
