New Study Offers Additional Evidence for the VASCADE MVP® XL System's Effectiveness in Electrophysiology Procedures with Large Bore Sheaths

Rhea-AI Summary

Haemonetics (NYSE: HAE) reported publication of a large single-center retrospective cohort study from Emory University evaluating its VASCADE MVP® XL venous vascular closure system in electrophysiology procedures using large-bore sheaths (up to 17F OD). The study, funded by a Haemonetics grant, analyzed outcomes in 1,623 patients undergoing procedures such as pulsed field ablation for atrial fibrillation and left atrial appendage closure.

According to Haemonetics, the VASCADE MVP XL system achieved median hemostasis in 2 minutes, a 92.5% same-day discharge rate with median discharge time of 3.5 hours, and an overall vascular complication rate of 1.2% with no surgical interventions. The company also highlighted that in March 2026 the FDA granted expanded labeling for VASCADE MVP XL to cover procedures using 10–14F inner diameter and up to 17F outer diameter sheaths and noted it as the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD sheaths.

Market Context

Historical event 1067394 recorded a 2.05% 24-hour reaction, while this study adds clinical evidence ...

Analysis

Historical event 1067394 recorded a 2.05% 24-hour reaction, while this study adds clinical evidence rather than financial guidance. The platform record supports monitoring adoption evidence, with low short positioning as a contextual risk factor.

Key Figures

Patient cohort: 1,623 patients Sheath diameter: 17F outer diameter Median hemostasis: 2 minutes +4 more

7 metrics

Patient cohort 1,623 patients Retrospective cohort study

Sheath diameter 17F outer diameter Maximum procedural sheath size

Median hemostasis 2 minutes VASCADE MVP XL study results

Same-day discharge 92.5% VASCADE MVP XL study results

Median time to discharge 3.5 hours VASCADE MVP XL study results

Vascular complications 1.2% Overall study complication rate

Expanded labeling 10-14F inner diameter and up to 17F outer diameter FDA approval in March 2026

Historical Context

5 past events · Latest: Jul 08 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 08	Earnings scheduling	Neutral	+1.6%	Company scheduled first-quarter fiscal 2027 results and investor conference call.
Jun 05	Reporting update	Neutral	+2.0%	Company consolidated reporting segments into Apheresis and MedSurg beginning fiscal 2027.
Jun 02	Conference presentation	Neutral	-0.7%	Company announced its chief executive's fireside chat at a healthcare conference.
May 07	Fiscal results release	Neutral	+3.2%	Company posted fourth-quarter fiscal 2026 results and scheduled an investor conference call.
May 05	Conference presentation	Neutral	+0.5%	Company announced its chief executive's presentation at a healthcare conference.

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

Pattern Detected

HAE's five selected historical news events produced four positive 24-hour reactions and one negative reaction, although most announcements were informational rather than outcome-specific.

Key Terms

retrospective cohort study, hemostasis, pulsed field ablation, left atrial appendage closure

4 terms

retrospective cohort study medical

"The retrospective cohort study represents the largest reported cohort"

A retrospective cohort study is a research approach that looks back at existing records to compare outcomes for groups of people who were exposed to something (a drug, treatment, or risk factor) and those who were not. Think of it like reviewing past school report cards to see whether students who used a particular study method tended to do better; investors use these studies to judge the strength of evidence about safety or effectiveness, which can influence regulatory expectations, market confidence, and valuation risks.

hemostasis medical

"Results demonstrated that the VASCADE MVP XL system achieved rapid hemostasis"

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.

pulsed field ablation medical

"including pulsed field ablation (PFA) for 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.

left atrial appendage closure medical

"left atrial appendage closure (LAAC) or concomitant 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.

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

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BOSTON, Aug. 3, 2026 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced publication of a study providing new evidence supporting the safety and efficacy of Haemonetics' VASCADE MVP^® XL venous vascular closure system in large-bore sheath procedures. The retrospective cohort study represents the largest reported cohort using the VASCADE MVP XL system to date.

Conducted at Emory University and funded by a grant from Haemonetics, the single center retrospective study by an experienced user evaluated real-world outcomes in 1,623 patients who received the VASCADE MVP XL system following large bore (maximum 17F outer diameter (OD) sheaths) venous access electrophysiology procedures, including pulsed field ablation (PFA) for Atrial Fibrillation (AF), left atrial appendage closure (LAAC) or concomitant procedures. Results demonstrated that the VASCADE MVP XL system achieved rapid hemostasis (median 2 minutes), a 92.5% same-day discharge rate with a median time to discharge of 3.5 hours, and a strong safety profile with 1.2% overall vascular complications with no surgical interventions required.

"With real-world clinical evidence from a large and diverse patient population, we continue to demonstrate the VASCADE MVP XL system's consistent performance in large-bore venous closure," said Ken Crowley, Vice President and General Manager, Interventional Technologies at Haemonetics. "As physicians seek innovative closure technologies to help improve clinical outcomes and patient experiences across PFA, LAAC and concomitant procedures, VASCADE MVP XL is providing electrophysiology teams with a safe, reliable and effective solution delivering rapid hemostasis and enabling same-day discharge."

The study's corresponding author, David B. De Lurgio, M.D., Medical Director of Electrophysiology at Emory Saint Joseph's Hospital and professor of medicine at Emory University School of Medicine said, "What is particularly notable is that same-day discharge was consistently achieved, even with sheaths larger than historically used in device-based closure. With more than 1,600 patients in this cohort, the findings provide additional real-world evidence across a broad range of patients and procedures, including those with higher comorbidities in LAAC and concomitant cases."

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 OD procedural sheaths. The VASCADE MVP XL system is approved for vascular closure following procedures using market-leading technologies for PFA to treat atrial fibrillation such as Abbott's Volt^® PFA System, Boston Scientific's FARAPULSE^® and Medtronic's Sphere-9^® catheter, and LAAC solutions, including Boston Scientific's WATCHMAN TruSteer^®. FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, demonstrating that the VASCADE MVP XL system achieved rapid hemostasis with no complications and enabled same day discharge.¹ VASCADE MVP XL is the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths.

ABOUT HAEMONETICS

Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our Apheresis business features proprietary technologies designed to enhance safety, yield, donor satisfaction and operational efficiency for plasma and blood collectors around the world. Our MedSurg business offers Blood Management Technologies to help inform treatment decisions and optimize the management of blood products, and Interventional Technologies, including advanced vascular closure systems and sensor-guided technologies, designed to drive procedural effectiveness and elevate the patient experience. 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. 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 See Instruction for Use (IFU 4911) for complete details and safety information.

Investor Contacts:
Olga Guyette, Vice President-Investor Relations & Treasury	David Trenk, Sr. 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

What did the August 2026 VASCADE MVP XL study show for Haemonetics (NYSE: HAE)?

The study showed rapid hemostasis, high same-day discharge, and low complication rates for VASCADE MVP XL. According to Haemonetics, median hemostasis was 2 minutes, 92.5% of patients were discharged the same day, and overall vascular complications were 1.2% with no surgical interventions.

How many patients were included in the new VASCADE MVP XL large-bore sheath study for HAE?

The retrospective cohort included 1,623 patients treated with VASCADE MVP XL after large-bore venous access procedures. According to Haemonetics, this represents the largest reported cohort for the system to date, covering pulsed field ablation, left atrial appendage closure, and concomitant electrophysiology procedures.

What are the key clinical outcomes for hemostasis and discharge in the VASCADE MVP XL study?

The study reported median hemostasis in 2 minutes and a 92.5% same-day discharge rate. According to Haemonetics, median time to discharge was 3.5 hours, indicating rapid ambulation and discharge following large-bore venous electrophysiology procedures using the VASCADE MVP XL closure system.

What complication rates were observed with VASCADE MVP XL in large-bore electrophysiology procedures?

Overall vascular complications occurred in 1.2% of patients, with no surgical interventions required. According to Haemonetics, this safety profile was observed across more than 1,600 real-world patients undergoing pulsed field ablation, left atrial appendage closure, and concomitant procedures with large-bore sheaths.

What FDA labeling expansion did VASCADE MVP XL receive in March 2026 for HAE?

In March 2026, the FDA approved expanded labeling for VASCADE MVP XL to include procedures using 10–14F inner diameter and up to 17F outer diameter sheaths. According to Haemonetics, this expansion was supported by AMBULATE EXPAND trial data showing rapid hemostasis and same-day discharge.

Which electrophysiology technologies are supported by the VASCADE MVP XL system according to Haemonetics?

VASCADE MVP XL is approved for vascular closure after procedures using market-leading pulsed field ablation and left atrial appendage closure technologies. According to Haemonetics, these include Abbott’s Volt PFA System, Boston Scientific’s FARAPULSE and WATCHMAN TruSteer, and Medtronic’s Sphere-9 catheter.

What makes VASCADE MVP XL unique in large-bore venous closure for electrophysiology procedures?

According to Haemonetics, VASCADE MVP XL is the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths. The company cites both trial data and the new 1,623-patient cohort as supporting clinical evidence in large-bore settings.