Haemonetics Receives FDA Approval for Expanded Labeling of the VASCADE MVP® XL Venous Vascular Closure System

Rhea-AI Summary

Haemonetics (NYSE: HAE) received FDA approval to expand labeling for the VASCADE MVP XL venous vascular closure system to include procedures using 10-14F inner diameter and up to 17F outer diameter procedural sheaths.

Approval relied on the AMBULATE EXPAND trial (77 patients) that showed 0% major and 0% minor access site closure-related complications and a median time to ambulation of 2.4 hours. The device features a 25F disc and 19 mg resorbable collagen and is now cleared for larger PFA and LAAC procedures.

Positive

• FDA label expansion to support up to 17F outer diameter procedural sheaths
• AMBULATE EXPAND trial: 77 patients with 0% major and 0% minor closure-related complications
• Median time to ambulation 2.4 hours in pivotal trial
• Now cleared for larger PFA and LAAC electrophysiology procedures
• Device specs: 25F disc and 19 mg resorbable collagen

Negative

• None.

News Market Reaction – HAE

+2.60%

+2.60% Session close to close

In the Mar 31 session, HAE gained 2.60%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement expands VASCADE MVP XL’s FDA-approved labeling to larger 10–14F ID and up to 17F O...

Analysis

This announcement expands VASCADE MVP XL’s FDA-approved labeling to larger 10–14F ID and up to 17F OD sheaths used in PFA and LAAC for atrial fibrillation. The AMBULATE EXPAND trial reported 0% major and minor access-site complications in 77 patients across 8 centers and a median ambulation time of 2.4 hours, reinforcing safety and efficiency. Investors may watch for updates on adoption trends, procedure volumes in electrophysiology, and how this complements prior regulatory milestones and recent acquisitions.

Key Figures

Sheath size range (ID): 10–14F inner diameter Sheath size limit (OD): 17F outer diameter Trial enrollment: 77 patients +5 more

8 metrics

Sheath size range (ID) 10–14F inner diameter New VASCADE MVP XL labeling for venous closure procedures

Sheath size limit (OD) 17F outer diameter Approved maximum OD for procedures such as PFA and LAAC

Trial enrollment 77 patients AMBULATE EXPAND pivotal trial sample size

Trial sites 8 U.S. centers AMBULATE EXPAND multicenter design

Major complications 0% Access site closure-related complications in AMBULATE EXPAND

Minor complications 0% Access site closure-related complications in AMBULATE EXPAND

Median time to ambulation 2.4 hours AMBULATE EXPAND trial outcome measure

Device disc diameter 25F VASCADE MVP XL system design specification

Historical Context

5 past events · Latest: Feb 23 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Feb 23	FDA clearance	Positive	+0.6%	NexSys PCS with Persona PLUS received FDA 510(k) clearance.
Feb 20	Conference appearance	Neutral	+0.2%	CEO scheduled to speak at Raymond James investor conference.
Feb 05	Earnings posting	Neutral	-1.4%	Q3 FY26 results and webcast details posted to IR site.
Jan 09	Acquisition terms	Positive	-2.4%	Vivasure Medical deal up to €185M tied to vessel closure tech.
Jan 09	Acquisition close	Positive	-2.4%	Haemonetics completed Vivasure acquisition with €100M upfront cash.

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

Pattern Detected

Recent history shows mixed reactions, with mild gains on FDA/clearance news but selling pressure around acquisitions and some informational updates.

Recent Company History

Over the last few months, Haemonetics has combined regulatory and portfolio milestones with uneven share reactions. FDA clearance for the NexSys PCS system in February 2026 saw a modest +0.64% move, while a conference appearance had little impact. Earnings-related communication on February 5 coincided with a -1.41% move. The Vivasure Medical acquisition announcements on January 9 were followed by a -2.39% decline. Today’s FDA labeling expansion for VASCADE MVP XL adds to a series of regulatory wins against a backdrop of cautious trading.

Key Terms

pulsed field ablation, left atrial appendage closure, atrial fibrillation, median time to ambulation, +4 more

8 terms

pulsed field ablation medical

"used in market-leading technologies for pulsed field ablation (PFA) and left atrial"

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.

left atrial appendage closure medical

"technologies for pulsed field ablation (PFA) and left atrial appendage closure (LAAC)"

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.

atrial fibrillation medical

"LAAC to treat atrial fibrillation."

Atrial fibrillation is a common heart rhythm problem in which the heart’s upper chambers quiver instead of delivering steady, strong pumps, like a washing machine on an unbalanced cycle. It matters to investors because it increases use of medications, medical devices, hospital care and long‑term monitoring, drives demand for new treatments and diagnostics, and can affect healthcare costs, regulatory decisions and revenue prospects across drug, device and insurance markets.

median time to ambulation medical

"complications and a median time to ambulation (TTA) of 2.4 hours1."

Median time to ambulation is the middle value of how long it takes patients to start walking or moving around after a treatment, procedure, or illness—half of patients walk sooner and half later. Investors care because it summarizes recovery speed and functional benefit in a single number, which can predict hospital stay length, costs, patient satisfaction and market appeal for a therapy or device; think of it like the typical time it takes most people to get back on their feet after an event.

electrophysiology medical

"clinically proven in electrophysiology procedures using up to 17F OD procedural"

The study and measurement of the electrical signals that control cells and tissues, most commonly used to diagnose and treat heart rhythm problems and to test how nerves and muscles communicate. Investors care because electrophysiology drives products, procedures and drugs—like monitoring systems, catheter tools and implants—that can alter a medical device or drug maker’s sales, regulatory approvals and clinical trial outcomes; think of it as checking and fixing the wiring that makes the body run.

hemostasis medical

"collagen patch designed to promote rapid hemostasis for interventional and"

Hemostasis is the body’s process for stopping bleeding, using a coordinated set of responses that form clots and seal damaged vessels—think of it as the body's natural emergency patch and repair crew. It matters to investors because drugs, medical devices, and diagnostics that influence hemostasis can affect patient outcomes, regulatory approval paths, and market demand for treatments of bleeding disorders or clot-related conditions, so advances or safety issues can materially impact company value.

fda approval regulatory

"today announced U.S. Food and Drug Administration (FDA) approval to expand"

FDA approval is the U.S. Food and Drug Administration’s formal authorization for a drug, vaccine, or medical device to be marketed and sold after reviewers determine it meets standards for safety and effectiveness. For investors it’s a pivotal milestone because it opens the door to legal, large-scale sales and can sharply boost revenue potential while reducing regulatory uncertainty—like receiving a safety certificate that lets a new bridge carry traffic and tolls.

venous vascular closure system medical

"labeling for the VASCADE MVP® XL venous vascular closure system to include"

A venous vascular closure system is a medical device used to seal holes in veins after procedures that insert catheters or wires, speeding up the stop-bleeding process and allowing patients to move sooner — like a reliable bandage applied from inside the body. Investors care because these devices can reduce hospital time, lower complication rates and procedure costs, and win preference from doctors and insurers, all of which affect sales, reimbursement and market adoption.

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

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VASCADE MVP XL now approved for larger sheaths used in market-leading PFA and LAAC technologies

BOSTON, March 30, 2026 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced U.S. Food and Drug Administration (FDA) approval to expand the 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) and left atrial appendage closure (LAAC) to treat atrial fibrillation.

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, such as PFA and LAAC. The study enrolled 77 patients at eight U.S. centers and demonstrated 0% major and 0% minor access site closure-related complications and a median time to ambulation (TTA) of 2.4 hours¹. The study results were presented at the AF Symposium 2026 in Boston in February and published in the Journal of Cardiovascular Electrophysiology in March.

The VASCADE MVP XL system features a 25F diameter disc and 19 milligrams of resorbable, thrombogenic collagen and has been available in the U.S. for use with 10-12F ID and 15F maximum OD procedural sheaths. It is now the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths. With the VASCADE MVP XL system, there is no need for physicians to downsize a procedural sheath to a smaller size for closure, which can increase procedural time.

"VASCADE MVP XL has become the device of choice in advanced vascular closure, delivering differentiated clinical benefits and economic advantages for healthcare providers," said Ken Crowley, Vice President and General Manager, Interventional Technologies at Haemonetics. "With label expansion approval for fast-growing PFA and LAAC technologies, we are poised to accelerate our commercial strategy and momentum, with opportunities to support a greater number and broader range of procedures at hospitals and ambulatory surgical centers across the U.S."

Haemonetics' full portfolio of VASCADE^® vascular closure systems features an innovative collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis for interventional and electrophysiology procedures to help clinicians reduce the risk of complications, improve patient satisfaction, and enable same day discharge. In addition to the VASCADE MVP XL system, the portfolio includes the VASCADE system, designed for "small-bore" femoral arterial and venous closure with standard 5-7F ID procedural sheaths, and the VASCADE MVP^® system, designed for "mid-bore" multi-access femoral venous closure with 6-12F ID procedural sheaths.

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.

¹ In Per Protocol population.

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

David Trenk, Manager-Investor Relations (203) 733-4987 david.trenk@haemonetics.com

 

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SOURCE Haemonetics Corporation

FAQ

What did Haemonetics (HAE) receive FDA approval for on March 30, 2026?

Haemonetics received FDA approval to expand VASCADE MVP XL labeling to include 10-14F ID and up to 17F OD procedural sheaths. According to the company, this clears the device for larger sheaths used in PFA and LAAC electrophysiology procedures.

What were the AMBULATE EXPAND trial results supporting HAE's VASCADE MVP XL approval?

The pivotal AMBULATE EXPAND trial enrolled 77 patients and reported 0% major and 0% minor closure-related complications. According to the company, the study also showed a median time to ambulation of 2.4 hours.

How does the VASCADE MVP XL approval affect use in PFA and LAAC procedures for HAE (HAE)?

The approval allows use with larger sheaths common to PFA and LAAC, removing the need to downsize sheaths for closure. According to the company, this supports broader adoption in hospitals and ambulatory surgical centers.

What are the key device specifications for VASCADE MVP XL mentioned by Haemonetics (HAE)?

The VASCADE MVP XL features a 25F diameter disc and contains 19 mg of resorbable, thrombogenic collagen. According to the company, these features promote rapid hemostasis in interventional and electrophysiology procedures.

Will the VASCADE MVP XL approval change procedural workflow or ambulation times for patients?

The company reports a median time to ambulation of 2.4 hours in the pivotal trial, indicating faster post-procedure mobility. According to Haemonetics, the device can enable same-day discharge and may reduce procedure-related steps like sheath downsizing.

Is VASCADE MVP XL now uniquely proven for larger electrophysiology sheaths according to Haemonetics (HAE)?

Haemonetics says VASCADE MVP XL is now the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths. According to the company, this differentiates it for advanced vascular closure needs.