# Haemonetics Gains FDA Approval for PerQseal Elite Vascular Closure System

- URL: https://stocks.freetheai.org/news/haemonetics-gains-fda-approval-for-perqseal-elite-vascular-closure-system-9b1ac6
- Published: 2026-10-19T20:15:00Z
- Category: company_news; sentiment: bullish; impact: medium
- Symbols: [NYSE:HAE](https://stocks.freetheai.org/symbols/NYSE-HAE)
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Haemonetics Corporation (NYSE:HAE) secured U.S. Food and Drug Administration approval for its PerQseal Elite vascular closure system. Designed for large-bore arterial interventions, the device uses a bioabsorbable patch to seal blood vessel punctures without permanent implants or sutures. The approval broadens the company's domestic portfolio of large-bore closure tools following its acquisition of Vivasure Medical Limited in early 2026.

The system supports minimally invasive cardiovascular treatments by achieving blood flow stoppage in under one minute on average, based on clinical study data that also recorded zero major device complications. The device had previously earned European CE Mark approval in 2025 for arterial and venous procedures, helping strengthen the medical technology firm's presence in advanced vascular care.

Investors and healthcare professionals can monitor upcoming clinical trial presentations, as the company plans to share additional study findings at the Transcatheter Cardiovascular Therapeutics conference later in October 2026. Following the announcement, shares of Haemonetics Corporation traded around 118.70 USD, up 0.38 percent on the day.

## Key points

- Haemonetics Corporation received FDA approval for its sutureless PerQseal Elite vascular closure system for large-bore arterial procedures.
- Clinical trial results showed a mean time to blood flow stoppage under one minute with zero major device-related complications.
- The device uses a fully bioabsorbable patch, leaving no permanent materials behind inside the patient's blood vessel.
- The technology was acquired through Haemonetics' purchase of Vivasure Medical Limited in January 2026.
- Haemonetics plans to present detailed clinical data on PerQseal Elite at the TCT Conference at the end of October 2026.

## Questions and answers

### What is Haemonetics' PerQseal Elite system?

PerQseal Elite is an FDA-approved vascular closure system that uses a fully bioabsorbable patch to seal arterial blood vessel punctures without sutures, leaving no permanent implant behind.

### Why did the FDA approve PerQseal Elite?

The approval followed clinical study results demonstrating a mean time to blood flow stoppage under one minute and zero major device-related complications during large-bore arterial procedures.

### When will Haemonetics present clinical data for PerQseal Elite?

Haemonetics will present clinical trial data for the system at the Transcatheter Cardiovascular Therapeutics conference at the end of October 2026.