New Study Highlights Safety and Efficacy Profile of Haemonetics' VASCADE MVP® XL in Large-Bore Venous Access Closure Procedures

Rhea-AI Summary

Haemonetics (NYSE: HAE) announced publication of a 574‑patient single‑center comparative study showing VASCADE MVP XL achieved higher procedural success and reported 0% bleeding complications in large‑bore venous access closure for electrophysiology procedures. In March 2026 the FDA expanded labeling to cover 10–14F ID and up to 17F OD sheaths.

FDA clearance was supported by the multicenter AMBULATE EXPAND pivotal trial and a 31‑patient ultrasound sub‑study with encouraging early vascular imaging results.

Positive

• FDA expanded labeling to 10–14F ID and up to 17F OD procedural sheaths
• Study cohort of 574 consecutive patients supports clinical evidence
• Reported 0% bleeding complications in the comparative study
• AMBULATE EXPAND pivotal trial supported FDA approval

Negative

• Comparative study was retrospective, non‑randomized, single‑center
• Some VASCADE MVP uses in the study were outside prior approved indication
• Ultrasound sub‑study sample size was limited to 31 patients

Argus Apr 24 session

+0.52% close to close Open Argus

Details

News Market Reaction – HAE

In the Apr 24 session, HAE gained 0.52%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds real-world evidence to the VASCADE MVP XL story, highlighting superior perfor...

Analysis

This announcement adds real-world evidence to the VASCADE MVP XL story, highlighting superior performance and 0% bleeding complications in a 574-patient study of large-bore venous access closure. It builds on the recent FDA label expansion to sheaths up to 17F OD and supportive AMBULATE EXPAND and ultrasound sub‑study data. Investors may watch how these clinical results translate into adoption across pulsed field ablation and left atrial appendage closure procedures and into future earnings updates.

Key Figures

Study patients: 574 patients Bleeding complications: 0% Approved inner diameter: 10–14F ID +3 more

Study patients

574 patients

Retrospective single-center cohort for large-bore venous access closure

Bleeding complications

0%

Bleeding complications with VASCADE MVP XL in large-bore procedures

Approved inner diameter

10–14F ID

Expanded FDA labeling for VASCADE MVP XL venous closure system

Approved outer diameter

up to 17F OD

Expanded FDA labeling for VASCADE MVP XL venous closure system

Ultrasound substudy size

31 patients

Prospective ultrasound sub‑study assessing closure site imaging

Procedures evaluated

up to 17F OD sheaths

Electrophysiology procedures using large-bore venous access

Historical Context

5 past events · Latest: Apr 01

5 events

1. Apr 01

   Earnings date notice

   24h Move

   +1.1%

   Set timing for Q4 and full-year 2026 results and conference call.

2. Mar 30

   FDA label expansion

   24h Move

   +2.6%

   FDA approved expanded VASCADE MVP XL labeling for 10–14F ID and 17F OD sheaths.

3. Feb 23

   FDA 510(k) clearance

   24h Move

   +0.6%

   NexSys PCS with Persona PLUS gained 510(k) clearance backed by large pivotal trial.

4. Feb 20

   Investor conference

   24h Move

   +0.2%

   CEO scheduled for fireside chat at Raymond James investor conference.

5. Feb 05

   Earnings posting

   24h Move

   -1.4%

   Posted Q3 FY2026 financial results and scheduled related conference call.

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

Key Terms

large-bore venous access, vascular closure system, catheter ablation, atrial arrhythmia, +4 more

8 terms

large-bore venous access medical

"in the context of large‐bore venous access closure procedures."

Large-bore venous access is a wide-diameter tube placed into a major vein to rapidly deliver fluids, blood, medications or to allow passage of medical devices during surgery and emergency care. For investors, it signals a specialized, higher-cost segment of the medical device and hospital-supply market—think of it as a highway rather than a side street—where device design, safety, procedure time and reimbursement can materially affect sales, adoption and clinical preference.

vascular closure system medical

"VASCADE MVP® XL vascular closure system with the VASCADE MVP® venous vascular closure system"

A vascular closure system is a medical device used to seal a hole in an artery after procedures that use a small tube (catheter) inserted into blood vessels; think of it as a plug or Band‑Aid for an artery that helps stop bleeding and let patients move sooner. Investors watch these devices because they can reduce procedure time, complications and hospital stays, which affects hospital purchasing, device adoption rates, reimbursement and the revenue potential and regulatory risk for makers.

catheter ablation medical

"574 consecutive patients undergoing catheter ablation for atrial arrhythmia"

Catheter ablation is a minimally invasive medical procedure in which a thin, flexible tube is threaded into the heart to destroy tiny areas of tissue that cause abnormal heart rhythms, typically using heat or freezing. Investors watch it because growing use or improved success rates can shift demand for specialized medical devices, hospital procedures and follow-up care, alter treatment costs, and compete with drug or implantable alternatives — like repairing a faulty circuit to restore reliable performance.

atrial arrhythmia medical

"undergoing catheter ablation for atrial arrhythmia, or left atrial appendage closure"

Atrial arrhythmia is an abnormal rhythm that starts in the heart’s upper chambers (the atria), causing the heartbeat to be too fast, too slow or irregular. Investors care because these conditions drive demand for medicines, monitoring devices and procedures, affect healthcare costs and hospital use, and can determine the commercial success or failure of clinical trials, regulatory approvals and medical technology — like a recurring technical fault that creates steady need for fixes.

left atrial appendage closure medical

"or left atrial appendage closure procedures."

A medical procedure that seals off the left atrial appendage, a small pouch in the heart where blood can pool and form clots in people with irregular heartbeats; sealing it is like plugging a gutter so debris can’t collect and cause a downstream flood. It matters to investors because devices, hospitals, and insurers involved in the procedure create revenue streams and regulatory or adoption changes can affect sales, costs and long‑term market size for related medical technology.

pulsed field ablation medical

"market-leading technologies for pulsed field ablation (PFA) to treat atrial fibrillation"

Pulsed field ablation is a heart procedure that uses very short, high-voltage electrical pulses to selectively disrupt abnormal heart tissue that causes irregular rhythms, rather than heating or freezing it. For investors, it matters because this approach can shorten procedure times, reduce damage to nearby structures, and potentially lower complication rates compared with traditional thermal methods, which can affect device adoption, hospital costs, and market demand for treatment tools.

electrophysiology procedures medical

"experience on Efficacy and Complications," was published earlier this week in the Journal of Cardiovascular Electrophysiology."

Electrophysiology procedures are medical treatments that diagnose and fix abnormal heart rhythms by sending tiny electrical signals through thin wires to map the heart’s wiring and then correct faulty spots. Investors care because the number and complexity of these procedures drive sales for medical device makers, hospital revenue and service contracts, and can be affected by regulatory rules and reimbursement changes — like electricians getting paid for fixing a house’s wiring.

anticoagulated medical

"high‑risk, fully anticoagulated population, offering further insight into vascular healing"

Anticoagulated means a person’s blood has been treated with medicine or a procedure to make it less likely to form clots, similar to adding oil to keep gears from sticking. For investors, this matters because anticoagulation affects safety and efficacy outcomes in clinical trials, changes the risk profile for medical devices and procedures, and can influence market size, regulatory decisions and reimbursement for therapies that interact with blood clotting.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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BOSTON, April 24, 2026 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced the publication of a new study comparing its VASCADE MVP^® XL vascular closure system with the VASCADE MVP^® venous vascular closure system in the context of large‐bore venous access closure procedures. This study, "VASCADE MVP-XL Versus VASCADE MVP for Large-Bore Venous Access-Site Closure in Electrophysiology Procedures: A Single-Center Experience on Efficacy and Complications," was published earlier this week in the Journal of Cardiovascular Electrophysiology.

The retrospective, non‐randomized, observational single‐center cohort study included a total of 574 consecutive patients undergoing catheter ablation for atrial arrhythmia, or left atrial appendage closure procedures. The study included some procedures in which VASCADE MVP was used outside the scope of its approved indication, which is for use with 6-12F inner diameter procedural sheaths. Results demonstrated VASCADE MVP XL's superior performance in the context of these large‐bore venous access closure procedures, achieving higher procedural success, a more consistent safety profile, and efficient hemostasis without complications, including 0% bleeding complications.

In March 2026, the U.S. Food and Drug Administration (FDA) approved expanded labeling for the VASCADE MVP XL venous vascular closure system to include procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths. With this label expansion, the VASCADE MVP XL system is approved for larger sheaths used in market-leading technologies for pulsed field ablation (PFA) to treat atrial fibrillation such as Boston Scientific's FARAPULSE^® and left atrial appendage closure (LAAC) solutions, including Boston Scientific's WATCHMAN TruSteer^®. VASCADE MVP XL is now the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths.

FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, a multicenter, prospective, single-arm, pivotal trial designed to evaluate the safety and effectiveness in technologies using 17F maximum OD procedural sheaths. The study results were published in the Journal of Cardiovascular Electrophysiology in March 2026. Additionally, findings from a prospective ultrasound sub‑study involving 31 patients were published in Heart Rhythm O2 yesterday and will be presented at the Heart Rhythm Society's Heart Rhythm 2026 in Chicago on Saturday, April 25, 2026 from 12:00 – 2:00 p.m. CT. This study provided an imaging‑based assessment of the closure site and demonstrated encouraging early vascular findings in a high‑risk, fully anticoagulated population, offering further insight into vascular healing following VASCADE MVP XL deployment.

"The expanded indication for the VASCADE MVP^® XL system supports the rapidly evolving electrophysiology landscape, including the adoption of next‑generation PFA and LAAC technologies and the growing number of concomitant procedures," said Jan Hartmann, M.D., Senior Vice President and Chief Medical Officer at Haemonetics. "By enabling reliable venous closure in large‑bore procedures, VASCADE MVP XL helps electrophysiology teams deliver safe, effective care across hospital‑based labs and increasingly time‑ and cost‑conscious outpatient settings, including ambulatory surgery centers."

Clinical data related to the VASCADE MVP XL system will be presented and discussed at HRS 2026, as part of a Haemonetics‑sponsored Rhythm Theater session entitled Efficient Workflows for AF Ablation: New Technologies and Sites of Service, scheduled for Saturday, April 25, 2026, at 10:30 a.m. CT.

About Haemonetics

Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components. To learn more about Haemonetics, visit www.haemonetics.com.

Cautionary Statement Regarding Forward-Looking Information

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with the expanded labeling of the VASCADE MVP XL venous vascular closure system and Haemonetics' plans or objectives related to the commercialization of such product enhancement. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics' current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, product quality; market acceptance; the effect of economic and political conditions; and the impact of competitive products and pricing. These and other factors are identified and described in more detail in Haemonetics' periodic reports and other filings with the U.S. Securities and Exchange Commission. Haemonetics does not undertake to update these forward-looking statements.

		Investor Contacts:
		Olga Guyette, Vice President-Investor Relations & Treasury	David Trenk, Manager-Investor Relations
		(781) 356-9763	(203) 733-4987
		olga.guyette@haemonetics.com	david.trenk@haemonetics.com
		Media Contact:
		Josh Gitelson, Sr. Director-Global Communications
		(781) 356-9776
		josh.gitelson@haemonetics.com

 

 

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SOURCE Haemonetics Corporation

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Haemonetics announce about VASCADE MVP XL on April 24, 2026 (HAE)?

VASCADE MVP XL showed higher procedural success and 0% bleeding complications in a 574‑patient study. According to the company, FDA labeling was expanded in March 2026 to include 10–14F ID and up to 17F OD procedural sheaths, supported by pivotal trial data.

How large was the study comparing VASCADE MVP XL and VASCADE MVP in electrophysiology procedures (HAE)?

The retrospective single‑center cohort included 574 consecutive patients undergoing catheter ablation or LAAC procedures. According to the company, the analysis compared procedural success, safety outcomes, and hemostasis between the two closure systems.

What FDA labeling change did Haemonetics receive for VASCADE MVP XL (HAE)?

In March 2026 the FDA expanded labeling to cover procedures using 10–14F inner diameter and up to 17F outer diameter sheaths. According to the company, this enables approved use with larger sheaths used in PFA and LAAC technologies.

What clinical evidence supported the FDA clearance for VASCADE MVP XL (HAE)?

FDA approval was supported by the multicenter AMBULATE EXPAND pivotal trial and published results. According to the company, the trial evaluated safety and effectiveness for technologies using up to 17F maximum outer diameter sheaths.

What did the ultrasound sub‑study reveal about VASCADE MVP XL vascular healing (HAE)?

A 31‑patient prospective ultrasound sub‑study demonstrated encouraging early vascular imaging findings in a fully anticoagulated, higher‑risk population. According to the company, these imaging results offer further insight into closure‑site healing after deployment.