Haemonetics announced FDA approval of the PerQseal Elite vascular closure system for large-bore arterial procedures.
The device uses a fully bioabsorbable patch to close arterial access sites following structural heart and endovascular interventions, including procedures using 14–22F sheaths and arteriotomies up to 26F.
The company acquired the technology through its January 2026 acquisition of Vivasure Medical. In the prospective, single-arm, multicenter ELITE arterial study, Haemonetics reported 0% major device-related vascular access complications under VARC-3 criteria and a mean time to hemostasis below one minute. Haemonetics Corporation
Primary source: Haemonetics FDA approval announcement, October 19
Why it matters strategically
Vascular closure is an important component of minimally invasive cardiovascular procedures.
Procedural success depends not only on the implanted therapeutic device but also on safe access and closure.
A closure device that reduces bleeding complications, procedure time, or postprocedural resource use could create clinical and economic value for hospitals.
However, the reported study results require careful interpretation.
A 0% observed major-complication rate in a single-arm study does not establish that PerQseal Elite is superior to competing closure technologies.
That conclusion would require appropriate comparative evidence.
