Boston Scientific's SEISMIQ 4CE Coronary Lithotripsy Catheter Meets Primary Endpoints in Pivotal FRACTURE Trial
核心洞察
Boston Scientific's FRACTURE IDE trial demonstrated that the SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter (搜索) achieved 93.3% freedom from major adverse cardiac events at 30 days, exceeding the prespecified performance goal.
The device showed 93.7% procedural success rate and achieved 100% successful stent delivery in 420 patients with severely calcified coronary artery disease (搜索).
The trial results support regulatory submission for the investigational device, which uses laser energy to generate acoustic pressure waves that fracture calcium deposits in coronary arteries (搜索).
Boston Scientific Corporation announced positive results from the pivotal FRACTURE Investigational Device Exemption (IDE) trial evaluating the SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter (搜索) for treating patients with severely calcified coronary artery disease (搜索). The study met its primary safety and effectiveness endpoints, with findings presented at the EuroPCR 2026 congress.
Trial Design and Patient Population
The prospective, non-randomized, single-arm FRACTURE trial enrolled 420 patients with severe coronary artery disease (搜索) across 46 sites in the United States and Europe. Patients will be followed for two years after their procedure to assess long-term outcomes.
Primary Endpoint Results
The trial achieved both primary safety and effectiveness endpoints with statistically significant results. The primary safety endpoint demonstrated a 93.3% rate of freedom from major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction (搜索) or target vessel revascularization at 30 days, exceeding the prespecified performance goal of 86.2% (p < 0.0001).
For effectiveness, the study showed a 93.7% rate of procedural success, defined as successful stent delivery with final residual stenosis of less than 50% and freedom from in-hospital MACE, surpassing the prespecified performance goal of 85.8% (p < 0.0001).
Device Performance and Stent Outcomes
Treatment with the SEISMIQ 4CE device resulted in 100% successful stent delivery and final in-stent residual stenosis less than 50%. A sub-analysis revealed a 94.2% average stent expansion rate at the most calcified segment of the artery, with favorable stent sizing that exceeded clinically significant thresholds.
"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," said Dr. Margaret McEntegart, co-principal investigator of the FRACTURE trial and director of Complex PCI and CTO Programs at Columbia University Irving Medical Center.
Technology and Clinical Need
The SEISMIQ 4CE catheter is an intravascular lithotripsy 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 calcium and prepare vessels for stent implantation.
Moderate-to-severe coronary calcification (搜索) affects nearly one-third of patients undergoing percutaneous coronary intervention to treat coronary artery disease (搜索), presenting a major challenge that can complicate stent delivery and expansion while increasing the risk of procedural complications such as vessel dissection.
Regulatory Path and Clinical Impact
"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," said Dr. Janar Sathananthan, chief medical officer, Interventional Cardiology Therapies, Boston Scientific.
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 clearance in 2025 for treating patients with severely calcified peripheral artery disease.
Dr. McEntegart noted that the trial data "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," as the prevalence of coronary artery disease (搜索) and adoption of IVL therapy continue to grow rapidly.