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.