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HAEBullishFDA Approvalnews
High materiality8/10

Haemonetics gains FDA approval for PerQseal Elite, expands large-bore closure portfolio

Oct 19, 2026, 4:24 PM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Regulatory clearance opens a new U.S. growth vector for Haemonetics, leveraging the Vivasure acquisition to accelerate revenue and potentially improve margins through device mix; positive sentiment around faster adoption and upcoming data could lift the stock in the near term.

AI summary

What happened, with direct paths to the underlying reporting

Haemonetics received FDA approval for PerQseal Elite, expanding its vascular closure lineup after acquiring Vivasure in January 2026. The sutureless, bioabsorbable patch secures arteriotomies up to 26F with rapid hemostasis while preserving guidewire access. ELITE data show zero major VARC-3 complications and sub-minute hemostasis, signaling a potential US adoption ramp and revenue driver.

  • FDA approves PerQseal Elite for large-bore arterial procedures.
  • System seals arteriotomies up to 26F with a bioabsorbable patch.
  • ELITE study shows 0% major complications and mean hemostasis under 1 minute.
  • TCT conference data to be presented end of October.

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