Haemonetics receives FDA approval for PerQseal Elite vascular closure system
Haemonetics Corporation announced that the U.S. Food and Drug Administration approved its PerQseal Elite system for large‑bore arterial procedures. The sutureless, bioabsorbable device seals arteriotomies up to 26 F and achieved a mean hemostasis time of less than one minute with 0 % major complications in the ELITE study. The approval follows Haemonetics’ acquisition of Vivasure Medical in January 2026 and expands its U.S. portfolio of large‑bore closure devices. The company will present additional clinical data at the Transcatheter Cardiovascular Therapeutics conference at the end of October.
Why it matters
The approval adds a new product to Haemonetics’ U.S. interventional portfolio, potentially increasing revenue from structural‑heart and endovascular procedures. Shares rose about 1.2 % in extended trading after the announcement, reflecting investor optimism.
Key facts
- 1The FDA granted approval on Oct. 19 2026. prnewswire.com
- 2PerQseal Elite provides sutureless closure for procedures using 14–22F sheaths and seals arteriotomies up to 26F. stocktitan.net
- 3The ELITE study reported 0 % major device‑related complications per VARC‑3 and a mean time to hemostasis of less than one minute. prnewswire.com
- 4Haemonetics acquired Vivasure Medical Limited in January 2026. prnewswire.com
- 5Shares rose 1.2 % in extended trading after the announcement. finance.yahoo.com
- 6Clinical data will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference at the end of October. stocktitan.net
Summary written by AlphAI AI Desk from 6 of 6 sources. Not investment advice. Figures are as stated by the linked sources.