FDA clears Haemonetics’ PerQseal Elite

Vascular closure device on sterile tray in cath lab after FDA clearance for new absorbable system

Key Points

01FDA approves Haemonetics’ (HAE) PerQseal Elite on Oct. 19, 2026
02Device targets sutureless closure in large-bore arterial procedures
03PerQseal Elite uses a fully bioabsorbable patch for up to 26F
04Clinical data to be presented at the TCT conference in October

FDA approval of PerQseal Elite

On October 19, 2026, the U.S. Food and Drug Administration approved Haemonetics’ (HAE) PerQseal Elite vascular closure system. The approval covers use in structural heart and endovascular procedures that require large-bore arterial access. Haemonetics (HAE) stated that this clearance expands its U.S. portfolio of large-bore closure devices, strengthening its offering for complex cardiovascular interventions.

Jan Hartmann, M.D., Senior Vice President and Chief Medical Officer at Haemonetics, described the FDA decision as an important milestone in the company’s strategy to bolster its presence and growth in advanced vascular closure. The approval positions PerQseal Elite alongside the company’s existing closure solutions aimed at managing hemostasis after major catheter-based procedures.

Design and clinical functionality

PerQseal Elite is described as a sutureless large-bore vascular closure system for procedures performed with 14–22F sheaths. The device is designed to manage large arterial access sites created during structural heart and endovascular interventions. By eliminating sutures, it aims to simplify the closure process while supporting rapid control of bleeding at the access site.

The system uses a fully bioabsorbable patch intended to seal arteriotomies up to 26F from within the vessel. The patch is designed to provide near-instantaneous hemostasis and to leave no permanent implant behind after it is absorbed. This internal sealing approach differentiates the device as a large-bore closure option that does not rely on retained metallic or polymeric components.

PerQseal Elite allows physicians to confirm hemostasis while maintaining guidewire access, providing an opportunity to verify vessel closure before finalizing the procedure. The system can be repositioned or recovered prior to implant release, giving clinicians additional control if the initial placement is not optimal. These features are intended to support precise deployment and procedural confidence during high-stakes structural heart and endovascular cases.

Next steps and data presentation

Haemonetics plans to present clinical data related to PerQseal Elite at the Transcatheter Cardiovascular Therapeutics (TCT) Conference at the end of October 2026. The company indicated that these data will be discussed in the context of the device’s performance and role in large-bore vascular closure.

The combination of FDA approval and upcoming data presentation highlights PerQseal Elite as a new option within the U.S. market for large-bore arterial access management. With regulatory clearance in place, attention is expected to focus on the clinical outcomes and real-world experience that will emerge as physicians adopt the system in structural heart and endovascular procedures.

Key Takeaways

01PerQseal Elite’s FDA approval marks a key step in expanding Haemonetics’ U.S. portfolio for large-bore vascular closure.
02The device’s sutureless, fully bioabsorbable design targets rapid hemostasis without leaving permanent implants.
03Operational features such as guidewire retention and repositionability are central to the system’s intended clinical utility.
04Forthcoming data at the TCT conference will be important for understanding PerQseal Elite’s performance in structural heart and endovascular use.

References