Boston, Massachusetts, United States, October 19, 2026
Haemonetics Corporation 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 cardiovascular medical technology, expanding options for closing arterial access sites following minimally invasive structural heart and endovascular interventions. The device uses a sutureless, fully bioabsorbable patch designed to seal openings in blood vessels from inside the vessel, without leaving a permanent implant behind. According to Haemonetics, the system is intended for procedures performed using 14–22 French (F) sheaths and can seal arteriotomies up to 26F. The technology is designed to support rapid hemostasis, the process of stopping bleeding, while allowing physicians to maintain guidewire access during deployment. The FDA approval strengthens Haemonetics’ portfolio of large-bore vascular closure technologies in the United States following its acquisition of Vivasure Medical Limited in January 2026. The development is particularly relevant to procedures such as transcatheter aortic valve replacement (TAVR), where reliable closure of large arterial access sites is an important part of procedural care.
Bioabsorbable Patch Technology Supports Vascular Closure
The PerQseal Elite vascular closure system is designed to address the challenges associated with closing large arterial access sites after catheter-based cardiovascular procedures. Such interventions may require large-bore sheaths to introduce specialized instruments into the vascular system. After the procedure, the access opening must be sealed effectively to control bleeding and support recovery. Unlike closure approaches that rely on sutures or permanent implanted components, PerQseal Elite uses a bioabsorbable sealing patch deployed from within the blood vessel. The patch is designed to provide closure while being absorbed by the body over time, leaving no permanent implant behind. The system also offers procedural flexibility, allowing physicians to assess whether bleeding has stopped while maintaining guidewire access. According to the company, clinicians can reposition or recover the device before the implant is released. These features are intended to support controlled deployment and integration into existing procedural workflows. The system is designed for use following structural heart and endovascular procedures involving 14–22F sheaths, with compatibility for arteriotomies up to 26F. Its approval provides U.S. physicians with another option for managing large-bore arterial access sites.
ELITE Study Reports Rapid Hemostasis and Safety Findings
Clinical evidence supporting the system includes findings from the prospective, single-arm, multicenter ELITE arterial study. According to Haemonetics, the study reported zero major device-related vascular access site complications under the VARC-3 criteria through 30 days and a mean time to hemostasis of less than one minute. These results highlight the system’s performance in the clinical evaluation, particularly its ability to achieve rapid bleeding control. However, the reported findings should be interpreted within the context of the study’s design and follow-up period. A single-arm study does not provide the same comparative evidence as a randomized controlled trial, and the reported complication rate does not mean that complications are impossible in broader clinical use. The findings nevertheless provide supporting evidence for the device’s further use in large-bore arterial procedures. PerQseal Elite received CE Mark approval in Europe in 2025 for both arterial and venous indications, preceding the U.S. FDA approval announced in October 2026. Haemonetics also plans to present and discuss additional clinical data at the Transcatheter Cardiovascular Therapeutics (TCT) Conference at the end of October 2026. Further clinical experience may help clarify the device’s performance across different patient populations and procedural settings.
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Haemonetics Expands Its Cardiovascular Device Portfolio
Haemonetics is a global medical technology company operating across blood management, plasma collection, and interventional technologies. The FDA approval of PerQseal Elite advances its strategy to expand its presence in large-bore vascular closure for structural heart and endovascular procedures. The acquisition of Vivasure Medical Limited in January 2026 added the technology to Haemonetics’ portfolio and supported its expansion into this segment of cardiovascular care. The system may be relevant to procedures such as TAVR and other minimally invasive interventions that require large arterial access. Its sutureless design and bioabsorbable patch offer a different approach to closing vascular access sites, with the potential to simplify certain procedural steps. Nevertheless, actual clinical outcomes depend on appropriate patient selection, procedural technique, and the device’s performance in clinical practice. The FDA approval represents a regulatory milestone rather than a guarantee of superior outcomes for every patient. As the technology enters broader U.S. clinical use, additional evidence and physician experience will help establish its role in cardiovascular interventions. PerQseal Elite adds a new FDA-approved option for large-bore arterial closure, reinforcing ongoing innovation in medical devices designed to support minimally invasive cardiovascular procedures.
Source: Haemonetics Corporation press release
