FRACTURE IDE trial of the Boston Scientific SEISMIQ™ 4CE Coronary Intravascular Lithotripsy Catheter meets primary safety and effectiveness endpoints

Rhea-AI Summary

Boston Scientific (NYSE: BSX) reported that the pivotal FRACTURE IDE trial of the SEISMIQ 4CE Coronary IVL Catheter in 420 patients with severe calcified CAD met its primary safety and effectiveness endpoints.

Freedom from 30-day MACE reached 93.3%, procedural success 93.7%, with 100% stent delivery and 94.2% average stent expansion.

Positive

• Primary safety endpoint met with 93.3% freedom from 30-day MACE, above 86.2% goal
• Primary effectiveness endpoint met with 93.7% procedural success, above 85.8% goal
• 100% successful stent delivery with final in-stent residual stenosis less than 50%
• 94.2% average stent expansion at the most calcified artery segment
• Pivotal data intended to support regulatory submission for SEISMIQ 4CE coronary IVL catheter

Negative

• None.

News Market Reaction – BSX

+1.59%

+1.59% Session close to close

In the May 19 session, BSX gained 1.59%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement reports that the FRACTURE IDE trial for the SEISMIQ 4CE coronary IVL catheter met ...

Analysis

This announcement reports that the FRACTURE IDE trial for the SEISMIQ 4CE coronary IVL catheter met primary safety and effectiveness endpoints, including 93.3% freedom from MACE and 93.7% procedural success in 420 severe CAD patients. The data complement earlier growth and strategic updates, such as Q1 2026 net sales of $5.203 billion and the recent MiRus investment. Investors may monitor longer-term outcomes from the planned two-year follow-up and any subsequent regulatory decisions for this technology.

Key Figures

Sample size: 420 patients Safety endpoint: 93.3% freedom from MACE at 30 days Performance goal (safety): 86.2% freedom from MACE +5 more

8 metrics

Sample size 420 patients FRACTURE IDE trial enrollment

Safety endpoint 93.3% freedom from MACE at 30 days Primary safety endpoint vs 86.2% goal (p < 0.0001)

Performance goal (safety) 86.2% freedom from MACE Prespecified safety performance goal at 30 days

Procedural success 93.7% rate Primary effectiveness endpoint vs 85.8% goal (p 0.0001)

Performance goal (effectiveness) 85.8% rate Prespecified goal for procedural success

Stent delivery 100% successful SEISMIQ 4CE treatment with final in-stent stenosis < 50%

Stent expansion 94.2% average rate At most calcified segment in sub-analysis

Trial sites & follow-up 46 sites; 2-year follow-up US and Europe FRACTURE trial design

Historical Context

5 past events · Latest: May 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 18	Share repurchase	Positive	+6.2%	$2B accelerated share repurchase under broader $5B authorization.
May 18	Strategic investment	Positive	+6.2%	$1.5B MiRus stake and option on SIEGEL TAVR business.
May 06	Acquisition target earnings	Positive	+1.0%	Penumbra Q1 2026 growth ahead of planned acquisition by BSX.
May 04	Conference & guidance	Neutral	+0.6%	Upcoming Bernstein conference appearance and Q2 2026 earnings call schedule.
Apr 22	Earnings results	Positive	+9.1%	Q1 2026 sales $5.203B with strong GAAP and adjusted EPS performance.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Over the past six months, positive corporate, strategic, and earnings headlines have generally coincided with positive next-day price reactions.

Recent Company History

This announcement adds favorable pivotal trial data to a string of recent positive developments for Boston Scientific. In Q1 2026, the company reported net sales of $5.203 billion and strong earnings, which was followed by a 9.09% price gain. Subsequent updates included conference and earnings-call scheduling, the pending Penumbra acquisition, and, on May 18, 2026, a $2 billion accelerated share repurchase and a $1.5 billion MiRus investment, both coinciding with a 6.15% move higher. Today’s pivotal SEISMIQ 4CE data fits into this pattern of clinically and strategically supportive news.

Key Terms

investigational device exemption, coronary artery disease, intravascular lithotripsy, percutaneous coronary intervention, +4 more

8 terms

investigational device exemption regulatory

"pivotal FRACTURE Investigational Device Exemption (IDE) trial evaluating the use"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

coronary artery disease medical

"to treat patients with severely calcified coronary artery disease (CAD)."

Coronary artery disease is a condition in which the blood vessels that supply the heart become narrowed or blocked by fatty buildup, reducing oxygen-rich blood flow and making the heart work harder. For investors, it matters because the condition drives demand for medications, medical devices, diagnostics and procedures, can affect healthcare spending and payer policies, and influences the financial prospects of companies involved in cardiovascular care—similar to how a clogged pipe changes maintenance and replacement needs.

intravascular lithotripsy medical

"catheter is an intravascular lithotripsy (IVL) device that uses laser energy"

A catheter-based procedure that uses short pulses of sonic pressure waves delivered inside blood vessels to crack and soften hard calcium deposits that narrow arteries, much like using controlled pebbles to chip away a stubborn rock clog in a pipe. Investors care because the technology can make minimally invasive artery treatments safer and more effective, potentially increasing procedure volumes, device sales, hospital adoption and reimbursement, which affect medical-device company revenues and healthcare costs.

percutaneous coronary intervention medical

"patients undergoing percutaneous coronary intervention (PCI) to treat CAD"

A minimally invasive heart procedure that opens narrowed or blocked coronary arteries by threading a thin tube from a wrist or groin to the heart and using a balloon and usually a small metal scaffold (stent) to restore blood flow. Investors care because the procedure drives sales and regulatory exposure for device makers, hospitals and suppliers, and influences healthcare costs and insurance payments—think of it like a plumbing repair that requires parts, skilled labor and follow-up maintenance.

major adverse cardiac events medical

"freedom from major adverse cardiac events (MACE) at 30 days"

Major adverse cardiac events (MACE) is a clinical composite measure that counts serious heart-related outcomes such as heart attack, stroke, urgent need for a heart procedure, or death from cardiovascular causes. Investors care because MACE is used to judge whether a drug, device, or treatment meaningfully reduces life‑threatening heart problems — like a safety and effectiveness scorecard — and outcomes can directly affect a medical product’s approval, market size, and commercial value.

target vessel revascularization medical

"only one patient underwent target vessel revascularization at the 30-day follow up"

A repeat procedure to reopen a blood vessel that was previously treated, usually in the heart, because it has narrowed or blocked again. For investors, this measure signals how well a device, drug or procedure performs over time—fewer repeat procedures suggest longer-lasting benefit, lower patient costs and better outcomes, much like fewer breakdowns indicate a more reliable car.

stenosis medical

"final residual stenosis of less than 50% and freedom from in-hospital MACE"

Stenosis is the abnormal narrowing of a body passage or opening—commonly arteries, heart valves, or the spinal canal—that restricts flow of blood, nerves, or other fluids. For investors, stenosis matters because it drives demand for surgeries, implants, drugs and diagnostic tests, affects patient outcomes and treatment costs, and can influence clinical trial results and the sales prospects of medical products tied to treating or diagnosing the condition.

pivotal trial medical

"Late-breaking data from global pivotal study achieved high rates"

A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.

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Late-breaking data from global pivotal study achieved high rates of freedom from major adverse cardiac events and procedural success in patients with severe coronary artery disease

MARLBOROUGH, Mass. and PARIS, May 19, 2026 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today 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. Findings from the trial were presented in a late-breaking trial session at the EuroPCR 2026 congress.

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.¹ 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.

"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, M.D., 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 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% 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% (p < 0.0001).
• A 93.7% rate of procedural success met the primary effectiveness endpoint, defined as successful stent delivery with a final residual stenosis of less than 50% and freedom from in-hospital MACE, exceeding a prespecified performance goal of 85.8% (p 0.0001).
  • Treatment with the SEISMIQ 4CE device resulted in 100% successful stent delivery and final in-stent residual stenosis less than 50%.
• A sub-analysis of the data found a 94.2% 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.²

"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, M.D., 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."

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.

About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.  

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, product approvals and launches, product performance and impact, and clinical trials. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 

Factors that may cause such differences include, among other things: economic conditions, including the impact of foreign currency fluctuations; future U.S. and global political, competitive, reimbursement and regulatory conditions, including changing trade and tariff policies; geopolitical events, conflicts and tensions; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property; litigation; financial market conditions; the execution and effect of our business strategy, including our cost-savings and growth initiatives; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACTS:
Angela Mineo
Media Relations
+1 (412) 491-9713
Angela.mineo@bsci.com

Lauren Tengler
Investor Relations 
+1 (508) 683-4479 
BSXInvestorRelations@bsci.com

*Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
**Dr. Margaret McEntegart is a paid consultant of Boston Scientific Corporation. She has not been compensated in connection with this press release.

¹ Barbato E, Gallinoro E, Abdel-Wahab M, et al. Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group. Eur Heart J. Nov 1 2023;44(41):4340-4356. doi:10.1093/eurheartj/ehad342
² Räber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, Radu MD, Joner M, Yu B, Jia H, Meneveau N, de la Torre Hernandez JM, Escaned J, Hill J, Prati F, Colombo A, di Mario C, Regar E, Capodanno D, Wijns W, Byrne RA, Guagliumi G; ESC Scientific Document Group. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018 Sep 14;39(35):3281-3300. doi: 10.1093/eurheartj/ehy285. Erratum in: Eur Heart J. 2019 Jan 14;40(3):308. doi: 10.1093/eurheartj/ehy460. PMID: 29790954

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SOURCE Boston Scientific Corporation

FAQ

What did Boston Scientific (BSX) announce about the FRACTURE IDE trial on May 19, 2026?

Boston Scientific announced that the pivotal FRACTURE IDE trial of the SEISMIQ 4CE Coronary IVL Catheter met its primary safety and effectiveness endpoints. According to Boston Scientific, results support regulatory submission and show high rates of freedom from major adverse cardiac events and procedural success.

What were the key safety results from the FRACTURE IDE trial of SEISMIQ 4CE for Boston Scientific (BSX)?

The FRACTURE trial achieved 93.3% freedom from major adverse cardiac events at 30 days, exceeding the 86.2% performance goal. According to Boston Scientific, this endpoint included cardiovascular death, myocardial infarction, or target vessel revascularization and supports the safety profile of the SEISMIQ 4CE catheter.

How effective was the SEISMIQ 4CE Coronary IVL Catheter in the FRACTURE trial for BSX?

The trial reported 93.7% procedural success, beating an 85.8% performance goal for effectiveness. According to Boston Scientific, procedural success meant successful stent delivery, final residual stenosis under 50%, and freedom from in-hospital major adverse cardiac events in treated patients.

What stent delivery and expansion outcomes were seen with SEISMIQ 4CE in Boston Scientific's FRACTURE study?

Treatment with SEISMIQ 4CE led to 100% successful stent delivery and final in-stent residual stenosis under 50%. According to Boston Scientific, a sub-analysis showed a 94.2% average stent expansion rate at the most calcified artery segment with favorable stent sizing.

How many patients and sites were included in the Boston Scientific FRACTURE IDE trial for SEISMIQ 4CE (BSX)?

The FRACTURE IDE trial enrolled 420 patients with severe coronary artery disease across 46 sites in the United States and Europe. According to Boston Scientific, enrolled patients will be followed for two years after their procedure to gather longer-term outcome data.

How might the FRACTURE IDE trial results impact Boston Scientific's SEISMIQ 4CE regulatory plans?

Boston Scientific stated that FRACTURE data serve as pivotal evidence to support regulatory submission for the SEISMIQ 4CE Coronary IVL Catheter. According to Boston Scientific, the device could offer physicians a differentiated option for treating severe coronary calcium during complex PCI lesion preparation.