Boston Scientific’s Seismiq Coronary IVL Study Meets Endpoints

Boston Scientific shared positive results from the pivotal FRACTURE Investigational Device Exemption (IDE) trial assessing its Seismiq 4CE coronary intravascular lithotripsy (IVL) catheter to treat patients with severely calcified coronary artery disease (CAD).

The study met its primary safety and effectiveness endpoints. It showed high rates of freedom from major adverse cardiac events (MACE) at 30 days, as well as procedural success.

The Seismiq 4CE catheter is an IVL device that uses laser energy in a balloon catheter to generate acoustic pressure waves that fracture calcium. The system’s visible, directional emitters were engineered to offer controlled, consistent energy delivery at low pressure to treat the calcium and prepare the vessel for stent implantation and maximum stent expansion to restore blood flow.

The FRACTURE trial enrolled 420 patients with severe CAD. The primary safety endpoint was met with a 93.3% rate of freedom from MACE. The rate of procedural success was 93.7%—this was defined as successful stent delivery with a final residual stenosis of under 50% and freedom from in-hospital MACE.

A sub-analysis of the data showed a 94.2% average stent expansion rate at the artery’s most calcified segment, with favorable stent sizing that exceeded clinically significant thresholds.

“As the prevalence of coronary artery disease and adoption of IVL therapy to address it continue to grow rapidly, data from this important trial will help advance our understanding of treatment for severely diseased, previously untreated coronary lesions and could help broaden the scope of coronary IVL treatment options over time,” said Dr. Margaret McEntegart, MD, PhD, co-principal investigator of the FRACTURE trial and director of Complex PCI and CTO Programs at Columbia University Irving Medical Center, New York. “Notably, stents were successfully delivered in all patients treated, no deaths occurred and only one patient underwent target vessel revascularization at the 30-day follow up, underscoring reassuring safety data for the SEISMIQ 4CE device.” 

The trial enrolled subjects who will be followed for two years after their procedure across 46 U.S. and European sites. The investigational Seismiq 4CE catheter is compatible with the same console used in the Seismiq IVL system with the Seismiq IVL peripheral catheter, which earned U.S. Food and Drug Administration (FDA) clearance last year to treat patients with severely calcified peripheral artery disease.

“Representing one of the fastest growing medical device segments in both peripheral and coronary care, IVL therapy can help address a critical level of coronary artery narrowing or blockage that poses a threat of heart attack, heart failure and other serious complications,” said Janar Sathananthan, MD, chief medical officer, Interventional Cardiology Therapies, Boston Scientific. “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.”