Haemonetics Receives FDA Approval for Expanded Labeling of the VASCADE MVP® XL Venous Vascular Closure System
MWN-AI** Summary
Haemonetics Corporation, a prominent medical technology company, recently announced that it has received FDA approval for expanded labeling of its VASCADE MVP® XL venous vascular closure system. This expansion allows the system to be used with larger procedural sheaths ranging from 10-14F inner diameter (ID) and up to 17F outer diameter (OD). The enhanced indication is particularly significant as it supports market-leading technologies for pulsed field ablation (PFA) and left atrial appendage closure (LAAC) procedures related to atrial fibrillation treatment.
The approval for the expanded labeling was based on the successful results of the AMBULATE EXPAND trial, a pivotal clinical study that evaluated the safety and effectiveness of the VASCADE MVP XL with larger procedural sheaths. Conducted at eight centers across the U.S. with 77 enrolled patients, the trial reported zero major or minor complications related to access site closure and a median time to ambulation of just 2.4 hours. These findings were presented at the AF Symposium 2026 and published in the Journal of Cardiovascular Electrophysiology.
With this approval, the VASCADE MVP XL system becomes the only extravascular venous closure option proven effective for electrophysiology procedures using up to 17F OD sheaths, eliminating the need for physicians to downsize procedural sheaths, thereby potentially reducing procedural time. Ken Crowley, Haemonetics' Vice President and General Manager for Interventional Technologies, stated that the expanded labeling positions the company to enhance its commercial strategy, broadening its market reach within hospitals and surgical centers.
Haemonetics continues to innovate with its VASCADE portfolio, which is designed to promote rapid hemostasis in various interventional procedures, ultimately aiming to improve patient outcomes and satisfaction.
MWN-AI** Analysis
Haemonetics Corporation (NYSE: HAE) recently achieved FDA approval for the expanded labeling of its VASCADE MVP® XL venous vascular closure system, now authorized for use with larger procedural sheaths (up to 17F outer diameter). This advancement is significant as it accommodates the rising demand for pulsed field ablation (PFA) and left atrial appendage closure (LAAC) technologies, both critical in treating atrial fibrillation.
The approval, backed by the AMBULATE EXPAND trial, highlights the device's safety—showing zero major or minor complications and a median ambulation time of only 2.4 hours. Such clinical efficacy positions the VASCADE MVP XL as a compelling choice for hospitals and ambulatory surgical centers, promising to streamline procedures and enhance patient outcomes.
From a market perspective, this development opens up substantial growth opportunities for Haemonetics. With its ability to cater to advanced vascular closure needs, the VASCADE MVP XL offers healthcare providers improved operational efficiency, which can translate into both clinical and economic advantages. The company’s strategic intent to leverage this FDA approval as a catalyst for increased market penetration in the cardiovascular space is noteworthy.
Investors should view the VASCADE MVP XL approval as a bullish indicator. The growth potential in the electrophysiology market, combined with Haemonetics’ existing portfolio of vascular closure systems, reinforces the company’s competitive edge. Furthermore, as hospitals continue to prioritize technologies that reduce procedural time and minimize complications, demand for Haemonetics’ innovative solutions is likely to increase.
In conclusion, while it is advisable to keep an eye on market dynamics and potential competitive pressures, the recent FDA approval represents a promising development for Haemonetics, making it a stock to consider for investors looking to capitalize on advancements in medical technology and expanding healthcare markets.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
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
Media Contact: Josh Gitelson, Sr. Director-Global Communications (781) 356-9776 |
David Trenk, Manager-Investor Relations (203) 733-4987 |
SOURCE Haemonetics Corporation
FAQ**
How does the expanded labeling of the VASCADE MVP® XL by Haemonetics Corporation HAE enhance its competitive positioning in the venous vascular closure market, particularly for pulsed field ablation and left atrial appendage closure technologies?
What insights can be gathered from the AMBULATE EXPAND trial's results that support Haemonetics Corporation HAE's claim of 0% major and minor complications associated with the VASCADE MVP® XL system for larger procedural sheaths?
With the expanded capabilities of the VASCADE MVP® XL, how does Haemonetics Corporation HAE plan to leverage this approval to accelerate its commercial strategy and market penetration in hospitals and ambulatory surgical centers?
What potential risks and uncertainties could affect the market acceptance and overall success of the VASCADE MVP® XL system for Haemonetics Corporation HAE, as indicated in their cautionary statement regarding forward-looking information?
**MWN-AI FAQ is based on asking OpenAI questions about Haemonetics Corporation (NYSE: HAE).
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