Zero major complications in a prospective multicenter trial is a number that tends to get noticed, and that result is now part of the FDA’s rationale for clearing a new approach to a procedure cardiologists perform thousands of times a year. Haemonetics on October 19 announced FDA approval of the PerQseal Elite vascular closure system for large-bore arterial procedures, the first U.S. clearance for the device after it received CE Mark in Europe in April 2025. The ELITE arterial study recorded 0% major VARC-3 complications through 30 days and a mean time to hemostasis under one minute, the two figures that define whether vascular closure actually works in this patient population.
The clinical case for PerQseal Elite rests on what it leaves behind, which is nothing permanent. The system uses a fully bioabsorbable patch that seals arteriotomies up to 26F from inside the vessel, covering the 14-to-22F sheath range common in TAVR and other structural heart procedures. Physicians can confirm hemostasis while keeping guidewire access open and reposition the device before final implant release, a workflow detail that matters in high-stakes structural heart suites where operator confidence in closure affects total procedure time. Suture-based systems such as Abbott’s Perclose ProGlide have dominated large-bore closure since the early 2000s, so a sutureless, bioabsorbable alternative competes on a meaningfully different mechanical premise.
The commercial context is straightforward. Haemonetics paid €100 million upfront and up to €185 million total to acquire Vivasure Medical in January 2026, roughly nine months before this FDA approval landed. PerQseal Elite is the asset that justified that price, and it now has a U.S. label to sell against. Haemonetics will present the full ELITE study data at the Transcatheter Cardiovascular Therapeutics conference at the end of October, giving interventional cardiologists their first structured look at the dataset before commercial promotion begins in earnest.
The number to track from TCT is whether the full ELITE dataset holds the 0% major complication rate across all enrolled sites, not just the summary figure in the approval announcement. Site-level variation in a multicenter trial often tells a different story than the pooled headline, and that granularity will shape how quickly structural heart programs adopt a device asking them to change a closure workflow they have used for two decades.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
