FDA Approves Haemonetics' PerQseal Elite Device

Haemonetics has won FDA approval for PerQseal Elite, a bioabsorbable vascular closure system for large-bore arterial procedures — the first U.S. regulatory payoff from the company's January 2026 acquisition of Vivasure Medical, and a new, differentiated entrant in a closure-device category long dominated by Teleflex's Manta.

What the approval covers

The approval is for arterial use following structural heart and endovascular procedures performed with 14 to 22F access sheaths — the large-bore category that includes transcatheter aortic valve replacement, endovascular aneurysm repair and other procedures requiring the biggest catheters in interventional practice. PerQseal Elite's bioabsorbable patch is delivered from inside the vessel and seals arteriotomies up to 26F, letting the operator confirm haemostasis before withdrawing access while the patch dissolves over time rather than remaining as a permanent implant. That design is the device's core differentiation from suture-based closure, which requires a pre-close step before the procedure begins and leaves permanent material at the access site.

An acquisition's first regulatory payoff

Haemonetics acquired Vivasure Medical, the Irish company that developed PerQseal Elite, in a deal that closed 9 January 2026. The transaction's announced terms were a €100 million upfront cash payment — roughly €52 million net of Haemonetics' earlier investments and loans into Vivasure — plus up to €85 million in additional contingent consideration tied to sales growth and development milestones, for a deal valued at up to €185 million (about $215 million). Vivasure had already filed the device's premarket approval application with FDA in June 2025 and held CE Mark approval in Europe covering both arterial and venous indications; this week's approval is the first U.S. regulatory outcome the acquisition has produced, and it covers only the arterial indication so far. For regulatory and quality teams managing device-company M&A, it is a concrete case of a PMA clearing roughly nine months after an acquisition closed on the strength of a submission the target company had already filed before the deal.

The clinical case, and what this outlet could not independently verify

Haemonetics' own characterization of its ELITE study reports 0% major device-related access-site complications through 30 days of follow-up, immediate median time to haemostasis, and no requirement for a pre-close suture technique. Those figures come from the company's own announcement and from wire-service coverage (Reuters, Dow Jones Newswires) rather than from an independent peer-reviewed publication or FDA's own summary of safety and effectiveness data, which was not accessible from this reporting environment. Readers relying on these figures for competitive or submission-strategy purposes should confirm them against FDA's eventual public PMA documentation once posted. As of this writing, specialty medtech trade press (MassDevice, MedTech Dive, Fierce Biotech) had not yet published its own reporting on this specific approval, though all three previously covered the underlying Vivasure acquisition; this story is sourced to Haemonetics' own announcement plus two independent wire services, Reuters and Dow Jones Newswires.

Competing against an established device

PerQseal Elite enters a large-bore vascular closure market where Teleflex's Manta device is the established, most direct competitor — also a sutureless, collagen-based closure system for the same class of large-bore arterial access. Abbott and Boston Scientific hold adjacent positions in the broader vascular closure category. Haemonetics said the approval adds another entry to its large-bore closure portfolio and that it plans to present additional clinical data at the Transcatheter Cardiovascular Therapeutics (TCT) conference later in October 2026.

Frequently asked questions

What did FDA approve, and when?

On 19 October 2026, FDA approved Haemonetics' PerQseal Elite vascular closure system for large-bore arterial procedures using 14 to 22F sheaths, with a bioabsorbable patch sealing arteriotomies up to 26F from inside the vessel.

Where did the device come from?

Haemonetics acquired developer Vivasure Medical in a deal closing 9 January 2026, valued at up to €185 million. Vivasure had submitted the PMA application in June 2025 and already held CE Mark approval in Europe.

What clinical data supported the approval?

Haemonetics' ELITE study reported 0% major device-related access-site complications through 30 days, immediate median time to haemostasis, and no pre-close suture step required — figures from the company's own announcement, not yet independently verified against FDA's own documentation.

How does PerQseal Elite compete in the market?

It enters the large-bore vascular closure category alongside Abbott and Boston Scientific devices and, most directly, Teleflex's Manta closure device.