/PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company committed to advancing innovative solutions that enhance patient outcomes, announced today U.S. Food and Drug Administration approval of the PerQseal Elite vascular closure system designed for large-bore arterial procedures. The clearance broadens Haemonetics' range of clinically advanced large-bore closure technologies for structural heart and endovascular interventions in the United States, following its acquisition of Vivasure Medical Limited in January 2026.

The PerQseal Elite system delivers sutureless, large-bore vascular closure after structural heart and endovascular procedures that use 14-22F sheaths. Its completely bioabsorbable patch closes arteriotomies up to 26F from inside the vessel, achieving near-instant hemostasis while leaving no permanent material behind. Clinicians can verify hemostasis while preserving guidewire access and retain the option to reposition or retrieve the system before final implant release. Data from the prospective, single-arm, multicenter ELITE arterial study showed zero major complications according to VARC-3 criteria along with a mean time to hemostasis under one minute. In 2025, PerQseal Elite obtained CE Mark approval in Europe covering both arterial and venous uses.

"FDA approval marks a key step in our plan to strengthen our position and expansion in advanced vascular closure by introducing fresh, valuable innovation that addresses changing procedural requirements," stated Jan Hartmann, M.D., Senior Vice President and Chief Medical Officer at Haemonetics. "PerQseal Elite offers the opportunity to further streamline minimally invasive interventions such as TAVR while promoting patient comfort and overall experience. We are delighted to provide physicians and their patients in the U.S. with this distinctive, patch-based method for large-bore vascular closure."

Professor Nicolas van Mieghem, MD, co-investigator of the ELITE study clinical trials and interventional cardiologist at ZOL Hospital in Genk, Belgium, noted, "I have observed that PerQseal Elite is straightforward to learn and intuitive to operate, with rapid hemostasis standing out as a key advantage. Across the ELITE study and our initial clinical use, the device has fit smoothly into procedural workflows for large-bore arterial interventions."

Clinical findings concerning PerQseal Elite will be presented and examined by Haemonetics at the Transcatheter Cardiovascular Therapeutics Conference at the close of October.

VARC-3 major device-related vascular access site complications through 30 days. See PerQseal Elite Instructions for Use.

About Haemonetics

Haemonetics is a global medical technology company focused on raising the quality, effectiveness and efficiency of health care. Its Apheresis business includes proprietary technologies that improve safety, yield, donor satisfaction and operational efficiency for plasma and blood collectors worldwide. Its MedSurg business provides Blood Management Technologies that support informed treatment decisions and optimize blood product management, along with Interventional Technologies that feature advanced vascular closure systems and sensor-guided solutions to boost procedural success and improve the patient experience. To learn more about Haemonetics, visit www.haemonetics.com.

Cautionary Statement Regarding Forward-Looking Information

Any statements in this press release that do not describe historical facts may represent forward-looking statements. Forward-looking statements in this press release may cover, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with the PerQseal Elite vascular closure system and Haemonetics' plans or objectives related to the commercialization of such product. Such forward-looking statements are not intended 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:
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Media Contact:
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SOURCE Haemonetics Corporation