Watch for initial U.S. adoption metrics and physician feedback at TCT Conference (late Oct 2026); competitive positioning against existing large-bore closure devices will determine market share ramp.
Price Chart
Executive Summary
Haemonetics received FDA approval for its PerQseal Elite vascular closure system for large-bore arterial procedures, expanding its interventional portfolio following the January 2026 acquisition of Vivasure Medical. The device demonstrated 0% major complications and sub-minute hemostasis in the ELITE study, positioning it for U.S. commercialization in the structural heart and endovascular markets.
Key Facts
- FDA approval for PerQseal Elite vascular closure system for large-bore arterial procedures (14–22F sheaths, seals arteriotomies up to 26F).
- ELITE arterial study showed 0% major complications per VARC-3 and mean time to hemostasis <1 minute.
- Device is fully bioabsorbable, sutureless, and allows guidewire access until implant release.
- Already has CE Mark approval in Europe for arterial and venous indications (2025).
- Clinical data to be presented at TCT Conference in late October 2026.
- Approval follows Haemonetics' acquisition of Vivasure Medical Limited in January 2026.
Financial Impact
Not disclosed; expands Haemonetics' large-bore closure portfolio in the U.S., a growth segment for structural heart and endovascular procedures.
Risk Factors
- Competitive large-bore closure devices already established in the U.S. market.
- Commercial adoption may be slower than expected if physicians prefer existing solutions.
- Reimbursement and hospital procurement cycles could delay revenue contribution.
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-prn-302913028 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 20, 2026 6d ago | Institutional Cluster | $117.11 $116.16 | ▼ −0.81% | ▲ +0.37% | $119.19 (+1.78%) |
Oct 19, 2026 7d ago | Press Release | $118.21 $117.11 | ▼ −0.93% | ▼ −1.46% | $119.19 (+0.83%) |
Oct 12, 2026 14d ago | Institutional Cluster | $122.06 $121.72 | ▼ −0.28% | ▼ −0.27% | $119.19 (−2.35%) |
Oct 8, 2026 18d ago | 8-K | $119.47 $118.69 | ▼ −0.65% | ▼ −1.25% | $119.19 (−0.23%) |
Sep 30, 2026 26d ago | Press Release | $104.37 $104.68 | ▲ +0.30% | ▼ −0.44% | $119.19 (+14.20%) |
Sep 30, 2026 27d ago | Court Ruling | $104.37 $104.68 | ▲ +0.30% | ▼ −0.44% | $119.19 (+14.20%) |
Aug 18, 2026 9w ago | 8-K | $104.65 $108.41 | ▲ +3.59% | ▲ +3.38% | $119.19 (+13.89%) |
Jun 9, 2026 19w ago | DEFA14A | $78.80 $79.84 | ▲ +1.32% | ▼ −0.38% | $119.19 (+51.26%) |
Jun 5, 2026 20w ago | 8-K | $71.28 $74.88 | ▲ +5.05% | ▲ +4.82% | $119.19 (+67.21%) |
May 7, 2026 24w ago | 8-K | $54.37 $55.12 | ▲ +1.38% | ▲ +0.55% | $119.19 (+119.22%) |
US Market Status
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