Haemonetics Announces FDA Approval of PerQseal® Elite Vascular Closure System
Key Highlights
- ➤FDA approves PerQseal Elite for large-bore arterial procedures in the U.S.
- ➤PerQseal Elite supports 14–22F sheaths and seals arteriotomies up to 26F.
- ➤ELITE study showed 0% VARC-3 major complications and under-one-minute hemostasis.
- ➤Haemonetics acquired Vivasure Medical in January 2026, expanding closure-device portfolio.
Expert Statements
Jan Hartmann, Senior Vice President and Chief Medical Officer at Haemonetics
“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”
Jan Hartmann, Senior Vice President and Chief Medical Officer at Haemonetics
“PerQseal Elite has the potential to further simplify minimally invasive procedures such as TAVR, while supporting patient comfort and experience.”
Jan Hartmann, Senior Vice President and Chief Medical Officer at Haemonetics
“We are pleased to offer physicians and their patients in the U.S. this novel, patch-based approach to large-bore vascular closure.”
Nicolas van Mieghem, Professor, co-investigator of the ELITE study clinical trials, and interventional cardiologist at 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.”
Nicolas van Mieghem, Professor, co-investigator of the ELITE study clinical trials, and interventional cardiologist at ZOL Hospital in Genk, Belgium
“In both the ELITE study and our early clinical experience, it has integrated well into procedural workflows for large-bore arterial interventions.”
Haemonetics Announces FDA Approval of PerQseal® Elite Vascular Closure System PR Newswire
BOSTON, Oct. 19, 2026 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced U.S. Food and Drug Administration (FDA) approval of the PerQseal(®) Elite vascular closure system for large-bore arterial procedures. The approval expands Haemonetics' portfolio of clinically-differentiated large-bore closure devices for structural heart and endovascular procedures in the U.S., following the company's acquisition of Vivasure Medical Limited in January 2026.
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