Haemonetics Announces FDA Approval of PerQseal® Elite Vascular Closure System

The FDA approval follows Haemonetics' acquisition of Vivasure Medical in January 2026.

Rhea-AI Summary

Haemonetics (NYSE: HAE) received FDA approval for its PerQseal Elite vascular closure system for use following large-bore arterial procedures.

The approval expands its U.S. closure-device portfolio for structural heart and endovascular procedures. The system uses a fully bioabsorbable patch and supports procedures performed with 14–22F sheaths. In the prospective, single-arm, multicenter ELITE arterial study, major device-related vascular access site complications through 30 days were 0% under VARC-3 criteria. Mean time to hemostasis, or stopping bleeding, was less than one minute.

PerQseal Elite received European CE Mark approval for arterial and venous indications in 2025. Haemonetics plans to present and discuss related clinical data at the Transcatheter Cardiovascular Therapeutics conference at the end of October.

4 points · 0 major

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0 major · 1 point

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Positive

• Moderate pointFDA approval expands Haemonetics' U.S. vascular closure portfolio for structural heart and endovascular procedures.
• Minor pointELITE study reported 0% major device-related vascular access site complications through 30 days under VARC-3 criteria.
• Minor pointELITE study mean time to hemostasis was less than one minute.
• Minor pointPerQseal Elite received European CE Mark approval in 2025 for arterial and venous indications.

Negative

• Minor pointELITE arterial evidence comes from a single-arm study.

Key Figures

Major complications: 0% Mean time to hemostasis: Less than one minute Procedural sheath range: 14–22F +1 more

Major complications

0%

ELITE arterial study; VARC-3 major complications through 30 days

Mean time to hemostasis

Less than one minute

ELITE arterial study

Procedural sheath range

14–22F

Structural heart and endovascular procedures

Arteriotomy closure size

Up to 26F

PerQseal Elite patch seals arteriotomies from within the vessel

Key Terms

hemostasis, bioabsorbable, arteriotomies, tavr

4 terms

hemostasis medical

"a mean time to hemostasis of less than one minute"

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.

bioabsorbable medical

"Its fully bioabsorbable patch seals arteriotomies up to 26F"

A bioabsorbable material is engineered to gradually dissolve and be absorbed or cleared by the body after it has fulfilled its medical role—like a temporary scaffold that disappears once tissue heals. Investors care because bioabsorbable products can cut the need for follow-up surgeries and long-term complications, affect regulatory approval and reimbursement prospects, and provide a competitive edge that can influence future sales and company valuation.

arteriotomies medical

"patch seals arteriotomies up to 26F from within the vessel"

An arteriotomy is a surgical cut made into an artery to gain access for procedures like placing catheters, stents, or performing repairs. For investors, the prevalence and safety of arteriotomies affect demand for closure devices, surgical tools and consumables because these cuts carry bleeding and infection risks and require reliable ways to seal the artery—like making a doorway in a water pipe that must be securely closed afterward.

tavr medical

"procedures such as TAVR"

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure that replaces a failing aortic heart valve by delivering a new valve through a blood vessel instead of opening the chest. It matters to investors because TAVR expands who can be treated, shortens hospital stays and recovery, and shapes revenue, regulatory risk and reimbursement for medical device makers, hospitals and insurers—similar to how a popular new product can reshape an industry’s market and costs.

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BOSTON, Oct. 19, 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 of the PerQseal^® Elite vascular closure system for large-bore arterial procedures. The approval expands Haemonetics' portfolio of clinically-differentiated large-bore closure devices for structural heart and endovascular procedures in the U.S., following the company's acquisition of Vivasure Medical Limited in January 2026.

The PerQseal Elite system provides sutureless, large-bore vascular closure following structural heart and endovascular procedures performed with 14 – 22F sheaths. Its fully bioabsorbable patch seals arteriotomies up to 26F from within the vessel, enabling near-instantaneous hemostasis and leaving nothing permanent behind. Physicians can confirm hemostasis while maintaining guidewire access, with the flexibility to reposition or recover the system until implant release. Results from the prospective, single-arm, multicenter ELITE arterial study demonstrated 0% major complications per VARC-3 and a mean time to hemostasis of less than one minute.¹ In 2025, PerQseal Elite received CE Mark approval in Europe for both arterial and venous indications.

"FDA approval represents an important milestone in our strategy to bolster our presence and growth in advanced vascular closure, with new and meaningful innovation to meet evolving procedural needs," said Jan Hartmann, M.D., Senior Vice President and Chief Medical Officer at Haemonetics. "PerQseal Elite has the potential to further simplify minimally invasive procedures such as TAVR, while supporting patient comfort and experience. We are pleased to offer physicians and their patients in the U.S. this novel, patch-based approach to 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, said, "I have found PerQseal Elite to be easy to adopt and intuitive to use, with rapid hemostasis being a particularly notable feature. In both the ELITE study and our early clinical experience, it has integrated well into procedural workflows for large-bore arterial interventions."

Clinical data related to PerQseal Elite will be presented and discussed by Haemonetics at the Transcatheter Cardiovascular Therapeutics^® (TCT) Conference at the end of October.

1. 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 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 designed 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 PerQseal Elite vascular closure system and Haemonetics' plans or objectives related to the commercialization of such product. 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.

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the FDA approve for Haemonetics' PerQseal Elite system?

The FDA approved PerQseal Elite for large-bore arterial procedures. The vascular closure system supports structural heart and endovascular procedures performed with 14–22F sheaths and uses a fully bioabsorbable patch.

What were the Haemonetics PerQseal Elite arterial study results?

The ELITE arterial study reported 0% major device-related vascular access site complications through 30 days under VARC-3 criteria and a mean time to stopping bleeding of less than one minute. The study was prospective, single-arm and multicenter.