The FDA approval, announced yesterday, expands Boston-based Haemonetics’ U.S. portfolio of large-bore closure devices for structural heart and endovascular procedures.
The PerQSeal Elite system is a sutureless, fully absorbable synthetic implant for large-bore vascular closure following structural heart and endovascular procedures performed with 14–22 Fr sheaths. Haemonetics says placement occurs from inside the vessel, enabling simpler, more controlled deployment than conventional closure techniques.
The PerQseal Elite system’s fully bioabsorbable patch seals arteriotomies up to 26 Fr from within the vessel fornear-instantaneous hemostasis, leaving nothing permanent behind. Physicians can confirm hemostasis while maintaining guidewire access. They can reposition or recover the system until implant release. According to Haemonetics, the prospective, single-arm, multicenter Elite arterial study showed no major complications per VARC-3 and a mean time to hemostasis of less than one minute.
“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,” Dr. Jan Hartmann, SVP and CMO at Haemonetics, said in a news release. “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.”
Said Dr. Nicolas van Mieghem, co-investigator of the Elite study clinical trials and interventional cardiologist at Ziekenhuis Oost-Limburg (ZOL) Hospital in Genk, Belgium: “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.”
