Boston Scientific CAD device shows promise in FRACTURE IDE trial

Boston Scientific Corporation has announced positive results from the pivotal FRACTURE Investigational Device Exemption (IDE) trial evaluating the use of the SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter to treat patients with severely calcified coronary artery disease (CAD).

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

Moderate-to-severe coronary calcification – a hardened build-up of calcium that can narrow coronary arteries – is present in nearly one-third of patients undergoing percutaneous coronary intervention (PCI) to treat CAD, presenting a major challenge that can complicate stent delivery and expansion and increase the risk of procedural complications such as vessel dissection.

The SEISMIQ 4CE catheter is an intravascular lithotripsy (IVL) device that uses laser energy within a balloon catheter to generate acoustic pressure waves that fracture calcium.

The system’s visible, directional emitters are designed to provide 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.

Dr Margaret McEntegart, M.D., PhD is co-principal investigator of the FRACTURE trial and director of Complex PCI and CTO Programs at Columbia University Irving Medical Center, New York.

The researcher said: “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.

“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 prospective, non-randomized, single-arm FRACTURE trial enrolled 420 patients with severe CAD. Findings from the trial met all pre-specified safety and effectiveness endpoints.

Of note:

• The primary safety endpoint was met with a 93.3 per cent rate of freedom from MACE, including cardiovascular death, myocardial infarction or target vessel revascularization at 30 days, exceeding a prespecified performance goal of 86.2 per cent (p < 0.0001).
• A 93.7 per cent rate of procedural success met the primary effectiveness endpoint, defined as successful stent delivery with a final residual stenosis of less than 50 per cent and freedom from in-hospital MACE, exceeding a prespecified performance goal of 85.8 per cent (p < 0.0001).
• Treatment with the SEISMIQ 4CE device resulted in 100% successful stent delivery and final in-stent residual stenosis less than 50 per cent.
• A sub-analysis of the data found a 94.2 per cent average stent expansion rate at the most calcified segment of the artery, with favorable stent sizing that exceeded clinically significant thresholds, helping to create space within the vessel and support optimal stent placement.

Janar Sathananthan, M.D. is chief medical officer, Interventional Cardiology Therapies, Boston Scientific.

Sathananthan said: “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.

“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.”

The trial enrolled patients who will be followed for two years after their procedure across 46 sites in the United States and Europe.

The investigational SEISMIQ 4CE Coronary IVL Catheter is compatible with the same console used in the SEISMIQ IVL System with the SEISMIQ IVL Peripheral Catheter, which received U.S. Food and Drug Administration (FDA) clearance in 2025 for the treatment of patients with severely calcified peripheral artery disease.

For more information on the FRACTURE trial, visit bostonscientific.com/fracture.