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Haemonetics has received FDA approval for its PerQseal Elite vascular closure system for large-bore arterial procedures. The approval comes less than a year after the company acquired Vivasure Medical in January 2026, and it expands Haemonetics’ U.S. portfolio of large-bore closure devices for structural heart and endovascular procedures.
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PerQseal Elite is a sutureless system for procedures using 14 to 22F sheaths. A fully bioabsorbable patch seals arteriotomies up to 26F from inside the vessel, which Haemonetics says enables near-instantaneous hemostasis and leaves nothing permanent behind. Physicians can confirm hemostasis while keeping guidewire access, and can reposition or recover the system until implant release. In the prospective, single-arm, multicenter ELITE arterial study, there were no major complications by VARC-3 criteria and mean time to hemostasis was under one minute. The device received CE marking in 2025 for arterial and venous indications.
For Haemonetics, the approval gives its Vivasure acquisition a U.S. product and builds its position in advanced vascular closure. Chief Medical Officer Jan Hartmann said it could further simplify procedures such as TAVR. Co-investigator Professor Nicolas van Mieghem called the system “easy to adopt and intuitive to use.”
For the broader MedTech space, the approval reflects continued focus on closure technology as large-bore structural heart procedures grow. Haemonetics will present clinical data at the TCT conference at the end of October.
