Boston Scientific Reports Positive Results for Coronary IVL Device in Severe Calcified CAD

New late-breaking data presented at EuroPCR 2026 showed Boston Scientific’s investigational SEISMIQ 4CE Coronary Intravascular Lithotripsy (IVL) Catheter achieved high procedural success and favorable safety outcomes in patients with severely calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).¹

Boston Scientific announced positive pivotal trial results Tuesday for its investigational SEISMIQ 4CE Coronary IVL Catheter, designed to treat patients with severely calcified CAD. Findings from the FRACTURE (NCT06181240) Investigational Device Exemption trial were presented during a late-breaking clinical trial session at EuroPCR 2026 in Paris.

The prospective, non-randomized, single-arm study enrolled 420 patients with severe CAD across 46 sites in the US and Europe. Investigators reported that the device met both primary safety and effectiveness end points, demonstrating strong procedural performance and low rates of major adverse cardiac events (MACE) at 30 days.

"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," Margaret McEntegart, MD, PhD, co-principal investigator of the FRACTURE trial, said in a statement. "Notably, stents were successfully delivered in all patients treated, no deaths occurred, and only 1 patient underwent target vessel revascularization at the 30-day follow-up, underscoring reassuring safety data for the SEISMIQ 4CE device."

Severe Coronary Calcification Remains a Major PCI Challenge

Moderate to severe coronary calcification remains one of the most difficult complications physicians encounter during PCI, often limiting successful stent delivery and expansion. Calcified lesions are associated with increased procedural complexity and higher risks of complications such as vessel dissection and stent under-expansion.

The SEISMIQ 4CE catheter uses intravascular lithotripsy technology, which delivers acoustic pressure waves through a balloon catheter to fracture calcium deposits within the coronary arteries. Boston Scientific said the system’s visible directional emitters are designed to provide controlled energy delivery at low pressure to improve vessel preparation before stent implantation.

Prior studies evaluating IVL technology have similarly demonstrated strong procedural outcomes in heavily calcified lesions. In the Disrupt CAD III (NCT03595176) study, IVL therapy achieved favorable long-term safety outcomes and effective stent expansion in patients with severely calcified coronary lesions.²

FRACTURE Trial Demonstrated High Procedural Success

The FRACTURE study achieved a 93.3% rate of freedom from MACE, including cardiovascular death, myocardial infarction, or target vessel revascularization, at 30 days, exceeding the prespecified performance goal of 86.2% (P < .0001).¹

The study also met its primary effectiveness end point, reporting a 93.7% procedural success rate, defined as successful stent delivery with residual stenosis below 50% and no in-hospital MACE.

Investigators reported 100% successful stent delivery among treated patients, with final in-stent residual stenosis below 50%. A sub-analysis also demonstrated a 94.2% average stent expansion rate at the artery’s most calcified segment, surpassing clinically meaningful thresholds associated with optimal stent deployment.

“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,” McEntegart said in a statement.

She added that stents were successfully delivered in all treated patients, with no deaths reported and only 1 patient requiring target vessel revascularization during the 30-day follow-up period.

Boston Scientific Eyes Regulatory Submission

The market for IVL technology has expanded rapidly in both coronary and peripheral vascular interventions as clinicians seek safer methods to manage heavily calcified lesions linked to heart attack, heart failure, and other cardiovascular complications.

“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,” Janar Sathananthan, MD, chief medical officer, Interventional Cardiology Therapies, Boston Scientific, said in a statement.

He noted that the FRACTURE data will support the company’s regulatory submission for the investigational coronary IVL catheter. The investigational SEISMIQ 4CE Coronary IVL Catheter is compatible with the same console used for the SEISMIQ IVL Peripheral Catheter system, which received clearance from the FDA in 2025 for treating severely calcified peripheral artery disease. Patients enrolled in the FRACTURE trial will continue to be followed for 2 years to evaluate the long-term safety and effectiveness of the device.

References

1. FRACTURE IDE trial of the Boston Scientific SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter meets primary safety and effectiveness endpoints. Boston Scientific. News release. May 19, 2026. Accessed May 19, 2026. https://news.bostonscientific.com/2026-05-19-FRACTURE-IDE-trial-of-the-Boston-Scientific-SEISMIQ-TM-4CE-Coronary-Intravascular-Lithotripsy-Catheter-meets-primary-safety-and-effectiveness-endpoints

2. Kereiakes DJ, Hill JM, Shlofmitz RA, et al. Intravascular lithotripsy for treatment of severely calcified coronary lesions: 1-year results from the Disrupt CAD III study. J Soc Cardiovasc Angiogr Interv. 2022;1(1):100001. doi:10.1016/j.jscai.2021.100001