Haemonetics Announces FDA Approval of PerQseal® Elite Vascular Closure System
Haemonetics received FDA approval for the PerQseal Elite vascular closure system for large-bore arterial procedures, expanding its U.S. large-bore closure portfolio for structural heart and endovascular use. The fully bioabsorbable patch seals arteriotomies up to 26F, with ELITE study data showing 0% VARC-3 major complications and mean time to hemostasis under one minute; PerQseal Elite won CE Mark approval in Europe in 2025.
Key figures
- Drug Name
- PerQseal Elite vascular closure system
- Seal up to
- 26F
- Sheath range
- 14-22F
- Mean time to hemostasis
- less than one minute
- Elite study major complications
- 0% per VARC-3
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.