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SEISMIQ™ 4CE Coronary Intravascular Lithotripsy Catheter
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- IVL overview
- Product details
- Clinical data
- Peer insights
IVL overview
Intravascular lithotripsy (IVL)
Intravascular lithotripsy (IVL) is a catheter‑based therapy designed to treat patients with calcified coronary artery disease. IVL delivers acoustic pressure waves inside a balloon to fracture hardened calcium, restore vessel compliance, and enable effective lesion preparation prior to definitive therapy, such as treating with a stent.
Laser‑based IVL takes traditional IVL a step further. By using focused laser energy and a quad-emitter design to generate acoustic pressure waves within the balloon, SEISMIQ 4CE is designed to deliver precise, consistent calcium modification—helping physicians prepare complex lesions with greater control.
Calcium morphologies treated by IVL:
Severe Concentric Calcium
Eccentric Calcium
Nodular Calcium
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Product details
SEISMIQ is a coronary Intravascular Lithotripsy (IVL) System - an advanced laser-based platform that is designed to deliver consistent acoustic output to treat a broad range of calcified lesions.
A SEISMIQ shift in coronary IVL
SEISMIQ 4CE is designed for:
Clinical data
2026
FRACTURE IDE Trial1
The FRACTURE IDE Trial is a prospective, multicenter, single-arm study using SEISMIQ 4CE to treat 420 patients with calcified coronary artery disease (CAD) with primary endpoints assessed at 30 days. Secondary endpoints including long-term safety and effectiveness will be measured through 24 months. This trial was conducted at 46 sites across the US, UK, and EU.
The FRACTURE IDE Trial studied a highly calcified subset of patients and lesions, including 100% site-reported severe angiographic calcium and OCT measurements of 27.4% nodular and arc of 271.9 ± 77.4 at the site of max calcium. The severely calcified de novo coronary lesions were ≥ 2.5 mm and ≤ 4.0 mm; with a lesion length ≤ 40 mm.
PRIMARY ENDPOINTS MET
Primary safety endpoint met:
93.3%
MACE-free at 30 days*
Primary effectiveness endpoint met:
93.7%
Procedural success**
Trial outcomes:
- Safety endpoint excluding peri-procedural MI: 99.3%
- Effectiveness endpoint excluding peri-procedural MI: 99.8%
- Final average MSA of 6.52 mm2
- Average stent expansion of 94.2%†
- Ventricular capture rate of 16.4%‡
The FRACTURE IDE Trial met its primary safety and effectiveness endpoints in the treatment of severely calcified de novo coronary lesions. The device was associated with high procedural success and low complication rate.
2026
RESTORE First-in-Human Study2
RESTORE was a prospective, multicenter feasibility study of 41 PCI patients with a single de novo, severely calcified coronary lesion (RVD 2.5-4.0 mm; length ≤ 60 mm) treated with SEISMIQ 4CE and followed for 30 days.
PRIMARY ENDPOINTS
Primary safety endpoint:
90.2%
MACE-free at 30 days*
Primary effectiveness endpoint:
89.5%
Procedural success**
Study outcomes:
- Final average MSA of 8.0 mm2
- Average stent expansion of 100%†
- Ventricular capture rate of 14.6%‡
In the RESTORE feasibility study, SEISMIQ 4CE facilitated substantial improvements in luminal area and stent expansion.
Peer insights
Physician Experience in the FRACTURE IDE Trial
School of Rock: FRACTURE Physician Experience Series
Hear from physicians involved in the FRACTURE IDE Trial on their experience with SEISMIQ 4CE. They share their perspectives on the data, the product design, and the importance of proper vessel preparation.
EDUCARE Webinar: Expanding The Calcium Toolbox
In this session, Dr. Margaret McEntegart explores contemporary approaches to managing calcified coronary lesions, including the role of IVL technology within the calcium modification toolbox and an introduction to the SEISMIQ 4CE device. The webinar reviews key findings from the FRACTURE IDE study, discusses imaging-guided treatment planning, compares calcium modification strategies within modern PCI practice, and presents case-based insights to optimize lesion preparation, treatment selection, and procedural outcomes.
Online medical training and education courses
The EDUCARE online platform makes healthcare education and training more relevant, more comprehensive, more personal, and more accessible. Register to access a library of procedural videos, case studies, training resources, and events.
*MACE defined as CV death, MI, TVR.
**Procedural success defined as DES delivery with a final residual stenosis < 50% and freedom from in-hospital MACE.
† MSA at site of max calcium relative to proximal and distal references.
‡ Ventricular capture is per patient per case.
References
1. McEntegart M. et al. Safety and efficacy of novel intravascular lithotripsy system for coronary calcium: FRACTURE study. EuroPCR 2026 LBCT May 19.
2. Price M, Budrys P, Baranauskas A, et al. Laser- and optics-based intravascular lithotripsy for the treatment of calcified coronary stenoses: the RESTORE first-in-human study. Circ Cardiovasc Interv. 2026;19:e016874. DOI: 10.1161/CIRCINTERVENTIONS.126.016874 www.ahajournals.org/doi/pdf/10.1161/CIRCINTERVENTIONS.126.016874
CAUTION: Investigational device. Limited by US law to investigational use only. Not available for sale.