Company Announcements

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.

 

 

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SOURCE Haemonetics Corporation