Haemonetics Receives FDA Approval for PerQseal® Elite Vascular Closure System, Expanding Large-Bore Closure Solutions
Haemonetics Corporation, a global medical technology company focused on developing innovative solutions to improve patient outcomes, has announced that the U.S. Food and Drug Administration (FDA) has approved its PerQseal® Elite vascular closure system for large-bore arterial procedures. The approval marks an important development in the company’s vascular closure portfolio and expands the treatment options available to physicians performing structural heart and endovascular procedures in the United States.
The PerQseal Elite system is designed to provide sutureless closure of large arterial access sites following minimally invasive cardiovascular procedures. Using a fully bioabsorbable patch, the system seals arteriotomies from inside the blood vessel, with the goal of achieving rapid hemostasis without leaving a permanent implant behind.
The FDA approval strengthens Haemonetics’ position in the advanced vascular closure market and follows the company’s acquisition of Vivasure Medical Limited in January 2026. Through this acquisition, Haemonetics expanded its portfolio of specialized vascular closure technologies intended to address the needs of physicians performing increasingly complex cardiovascular interventions.
The newly approved system is designed for procedures using large-bore sheaths ranging from 14 French (F) to 22F. It can seal arterial openings up to 26F, according to the company, and incorporates features intended to support procedural control, including the ability to confirm hemostasis while maintaining guidewire access. Physicians can also reposition or recover the system until the implant is released.
Clinical findings from the prospective, single-arm, multicenter ELITE arterial study demonstrated a reported rate of 0% major complications under the Valve Academic Research Consortium-3 (VARC-3) criteria and a mean time to hemostasis of less than one minute. These findings support the company’s presentation of PerQseal Elite as a potential option for simplifying large-bore vascular closure, although individual outcomes can vary depending on patient characteristics and procedural circumstances.
FDA Approval Expands Haemonetics’ Vascular Closure Portfolio
The FDA’s approval of PerQseal Elite represents a significant regulatory milestone for Haemonetics as it continues to develop and expand its medical technology offerings.
Vascular closure devices are used after catheter-based procedures to close the access site created when clinicians insert instruments into a blood vessel. In cardiovascular interventions, physicians may use large-bore sheaths to introduce specialized devices and equipment through an artery. Once the procedure is complete, the access site must be closed effectively to help control bleeding and support patient recovery.
Traditional closure approaches may involve sutures, compression or other techniques, depending on the procedure and the patient’s clinical circumstances. Devices designed specifically for large-bore access sites aim to provide another method for managing these openings after catheter-based interventions.
PerQseal Elite is designed to close the arterial access site using a patch-based, sutureless approach. Rather than relying on a permanent implant, the system uses a fully bioabsorbable patch intended to provide closure while subsequently being absorbed by the body.
For physicians, the system’s design is intended to support procedural efficiency while providing control over device placement before final release. Its ability to maintain guidewire access during confirmation of hemostasis may also offer additional flexibility during the closure process.
The approval expands Haemonetics’ range of clinically differentiated large-bore closure technologies in the U.S. market, particularly for structural heart and endovascular procedures where dependable access-site management is an important part of the overall intervention.
How the PerQseal Elite System Works
The PerQseal Elite vascular closure system is designed to seal large arterial access sites from within the blood vessel following minimally invasive procedures.
The system uses a fully bioabsorbable patch to close the arteriotomy, which is the opening created in an artery during vascular access. According to Haemonetics, the device supports closure of arteriotomies up to 26F following procedures performed with 14F to 22F sheaths.
One of the system’s distinguishing features is its sutureless design. The patch-based approach is intended to close the arterial opening without leaving a permanent implant behind. This may be relevant in procedures where physicians seek an alternative to conventional closure methods.
The company also reports that the system is designed to achieve near-instantaneous hemostasis. Hemostasis refers to the process of stopping bleeding, making it a central consideration when closing an arterial access site after a cardiovascular procedure.
Rapid hemostasis may help clinicians complete the closure process efficiently. However, the time required and the patient’s recovery depend on multiple factors, including the procedure performed, the condition of the blood vessel and the patient’s individual medical characteristics.
Another important feature is the ability to confirm hemostasis while maintaining guidewire access. Guidewires are commonly used during catheter-based interventions to help clinicians navigate instruments through blood vessels. Preserving access during part of the closure process can give physicians flexibility while they assess whether the access site has been adequately sealed.
PerQseal Elite also allows physicians to reposition or recover the system until implant release. This feature is intended to provide additional control before the patch is finally deployed.
Together, these design elements aim to support a closure process that combines rapid sealing, procedural flexibility and the use of bioabsorbable material.
Supporting Structural Heart and Endovascular Procedures
The FDA approval is particularly relevant to structural heart and endovascular procedures, which frequently require access to blood vessels through catheter-based techniques.
Structural heart interventions address conditions involving the heart’s valves and other structural components. These procedures can allow physicians to treat selected cardiovascular conditions without relying exclusively on conventional open-heart surgery.
One example is transcatheter aortic valve replacement (TAVR), a minimally invasive procedure used to treat certain patients with aortic valve disease. During TAVR, physicians guide specialized equipment through the vascular system to deliver a replacement valve to the heart.
Depending on the procedure and equipment used, large-bore arterial access may be necessary. Closing the access site after the intervention is an important step in completing the procedure and managing the risk of bleeding and other vascular complications.
Endovascular procedures similarly use instruments introduced through blood vessels to diagnose or treat vascular conditions. As catheter-based techniques continue to develop, clinicians require access-site closure solutions suited to the size of the instruments and the specific demands of each procedure.
Haemonetics said PerQseal Elite has the potential to further simplify minimally invasive procedures such as TAVR while supporting patient comfort and experience.
Jan Hartmann, M.D., senior vice president and chief medical officer at Haemonetics, described the approval as an important step in the company’s vascular closure strategy.
“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,” Hartmann said.
He added that the system could help simplify minimally invasive procedures while supporting the experience of patients undergoing treatment.
“We are pleased to offer physicians and their patients in the U.S. this novel, patch-based approach to large-bore vascular closure,” Hartmann said.
The comments reflect the company’s focus on developing technologies that address specific challenges encountered during complex cardiovascular procedures.
ELITE Arterial Study Reports Favorable Closure Findings
Clinical evidence played an important role in the evaluation of PerQseal Elite. According to Haemonetics, the prospective, single-arm, multicenter ELITE arterial study reported a 0% major complication rate under VARC-3 criteria and a mean time to hemostasis of less than one minute.
The study design was prospective, meaning clinical information was collected according to a planned approach as participants underwent evaluation. It was also conducted across multiple centers, allowing the technology to be assessed in more than one clinical setting.
The study was single-arm, meaning it did not include a separate randomized comparison group within the described design. As a result, the reported findings provide information about outcomes observed with the system but should not automatically be interpreted as demonstrating superiority over other closure technologies.
The reported 0% major complication rate under VARC-3 criteria is a specific study finding. It does not mean that the device carries no risk or that complications cannot occur in other patients or clinical settings. The interpretation of clinical findings depends on the number of patients studied, the definitions used, the duration of follow-up and other elements of the study methodology.
Similarly, the mean time to hemostasis of less than one minute describes the average reported result in the study. Individual procedures may differ, and the time needed to achieve hemostasis can depend on patient anatomy, procedural factors and the clinical team’s assessment.
Nevertheless, the findings provide clinical information supporting Haemonetics’ development and regulatory progress with the system.
As the device enters the U.S. market following FDA approval, further clinical experience may contribute to a broader understanding of how it performs across different patient populations and procedural settings.
Physicians Highlight Ease of Use and Rapid Hemostasis
Professor Nicolas van Mieghem, MD, an interventional cardiologist at ZOL Hospital in Genk, Belgium, and a co-investigator in the ELITE clinical studies, shared his experience using PerQseal Elite.
“I have found PerQseal Elite to be easy to adopt and intuitive to use, with rapid hemostasis being a particularly notable feature,” van Mieghem said.
He also noted that the system had integrated well into procedural workflows during the ELITE study and early clinical experience involving large-bore arterial interventions.
“In both the ELITE study and our early clinical experience, it has integrated well into procedural workflows for large-bore arterial interventions,” he said.
Physician experience is an important consideration when introducing new medical technology into clinical practice. A device must not only perform its intended technical function but also fit into the practical sequence of a procedure.
Ease of use can influence how clinicians interact with a device, while the ability to maintain control during deployment may be relevant when managing vascular access closure.
However, experiences reported by individual clinicians do not necessarily predict outcomes for every user or patient. Wider clinical adoption typically involves continued assessment of safety, effectiveness, procedural suitability and training requirements.
Van Mieghem’s comments provide a perspective on the system’s usability and its integration into the workflows used during large-bore arterial procedures.
Acquisition of Vivasure Medical Strengthens Haemonetics’ Strategy
The PerQseal Elite approval follows Haemonetics’ acquisition of Vivasure Medical Limited in January 2026. The acquisition forms part of the company’s broader efforts to expand its presence in advanced vascular closure technologies.
Medical technology companies often expand their portfolios through acquisitions that add specialized products, intellectual property or clinical capabilities. In this case, the acquisition provided Haemonetics with access to Vivasure’s vascular closure technology and helped broaden its offerings for large-bore procedures.
The vascular closure market serves clinicians who need to manage access sites created during a range of cardiovascular and endovascular interventions. As minimally invasive procedures become an important option for selected patients, the requirements for closure technologies can evolve alongside the devices and techniques used during treatment.
Haemonetics’ strategy is focused on providing solutions that address these changing procedural needs. The PerQseal Elite system adds a bioabsorbable patch-based option to the company’s portfolio for large-bore closure.
The device had previously received CE Mark approval in Europe in 2025 for both arterial and venous indications. The subsequent FDA approval for large-bore arterial procedures represents a further regulatory milestone, this time for the U.S. market and the indication specified in the announcement.
Regulatory approvals are jurisdiction-specific, and the approved indications may differ between markets. Physicians and healthcare organizations must therefore follow the applicable product labeling and regulatory requirements in their region.
The combination of the acquisition, European regulatory progress and U.S. approval illustrates the company’s ongoing work to expand access to its vascular closure technologies.
Clinical Data to Be Presented at TCT Conference
Haemonetics announced that clinical data related to PerQseal Elite would be presented and discussed at the Transcatheter Cardiovascular Therapeutics (TCT) Conference at the end of October.
The conference provides an opportunity for clinicians and other cardiovascular specialists to review research and developments relevant to catheter-based cardiovascular treatment. Presentation of additional clinical information can help healthcare professionals learn more about the evidence supporting new technologies and their potential role in clinical practice.
For PerQseal Elite, further discussion of clinical data may provide additional context regarding the study findings, procedural experience and use of the system in large-bore arterial interventions.
Clinical presentations can also contribute to professional discussion about the appropriate patient populations for a technology, practical considerations during use and the questions that may warrant further evaluation.
As with any medical device, clinical evidence should be considered alongside the approved indication, relevant product information and the individual patient’s needs. Decisions about vascular closure methods remain the responsibility of qualified clinicians, who must assess the suitability of available approaches for each procedure.
Advancing Large-Bore Vascular Closure Technology
The FDA approval of PerQseal Elite represents a new development in Haemonetics’ efforts to expand its advanced vascular closure portfolio in the United States.
The system offers a sutureless, bioabsorbable patch-based approach for closing large arterial access sites following structural heart and endovascular procedures. Its design includes support for 14F to 22F sheath procedures, closure of arteriotomies up to 26F, the ability to assess hemostasis while maintaining guidewire access and the flexibility to reposition or recover the system before implant release.
The ELITE arterial study reported a 0% major complication rate under VARC-3 criteria and a mean time to hemostasis of less than one minute. These findings, together with physician feedback on usability and workflow integration, form part of the clinical information supporting the system’s development.
For Haemonetics, the approval also advances a strategy that gained momentum following the acquisition of Vivasure Medical in January 2026. The company is positioning PerQseal Elite as an additional option for physicians who perform complex cardiovascular procedures requiring large-bore arterial access.
As the system becomes available in the U.S. market, its use will be guided by the approved indication, clinical judgment and ongoing evaluation of its performance in practice.
The development highlights the continued evolution of medical device technology for minimally invasive cardiovascular treatment, where effective access-site management remains an important consideration for physicians and patients alike.
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