PerQseal Elite, Haemonetics’ fully bioabsorbable patch for closing large arterial punctures, has received U.S. FDA approval, the Boston-based company announced on 19 October 2026. The device is intended for sutureless closure of the artery after structural heart and endovascular procedures performed through 14F to 22F sheaths. Haemonetics describes the decision as an approval, while other reports have called it a clearance, and the company’s release does not state which regulatory pathway was used. This report sets out what was announced, what the clinical data show and what has not been disclosed.
PerQseal Elite: key takeaways
- The FDA decision on PerQseal Elite was announced by Haemonetics on 19 October 2026 and covers large-bore arterial procedures.
- The company says the patch seals arterial openings up to 26F and is used with 14F to 22F sheaths.
- In the prospective ELITE arterial study, the company reports 0% major complications through 30 days and a mean time to hemostasis under one minute.
- Haemonetics gave no pricing, launch date or financial figures.
- The regulatory pathway is not stated in the release, so we use the company’s word, approval.
What Haemonetics announced
According to the release from Haemonetics, the FDA decision covers large-bore arterial procedures, meaning operations in which a large tube, called a sheath, is passed into an artery, usually in the groin. These include structural heart procedures such as transcatheter aortic valve replacement, known as TAVR, and endovascular procedures. Haemonetics says the device gives physicians a patch-based way to close the puncture without sutures, and that it is offering the approach to U.S. physicians and patients.
Jan Hartmann, M.D., the company’s senior vice president and chief medical officer, called the decision an important milestone in the strategy to bolster its presence and growth in advanced vascular closure. He added that the device has the potential to further simplify minimally invasive procedures such as TAVR. That is the company’s view, and the release offers no data on procedure times or hospital stays.
How the PerQseal Elite patch works
Per the company, PerQseal Elite is a fully bioabsorbable patch that seals the arteriotomy, the opening in the artery wall, from inside the vessel and leaves nothing permanent behind. Haemonetics says physicians can confirm hemostasis, meaning that bleeding has stopped, while keeping guidewire access, and can reposition or recover the system until the implant is released.
French sizes measure the outer diameter of a sheath in thirds of a millimetre. By our calculation, 14F is about 4.7 mm, 22F is about 7.3 mm and the 26F opening the patch is said to seal is about 8.7 mm. These are among the larger access sites in routine cardiovascular care, which is why the closure step receives so much attention.
What the ELITE arterial study reported
The company cites the prospective, single-arm, multicenter ELITE arterial study. It reports 0% major complications through 30 days, as defined by the VARC-3 criteria from the Valve Academic Research Consortium, and a mean time to hemostasis of under one minute. The text of the release does not give the number of patients, the participating sites or the other endpoints.
Professor Nicolas van Mieghem, a co-investigator and interventional cardiologist at ZOL Hospital in Genk, Belgium, said he found the device easy to adopt and intuitive to use. Haemonetics says clinical data will be presented at the TCT conference at the end of October 2026, which should allow clinicians to see the full results.
How to read the safety and speed claims
This section is our analysis. A single-arm study has no control group, so its results show how the device performed in the people studied but cannot show whether it performs better or worse than other closure methods. A rate of 0% major complications is encouraging, yet its meaning depends on how many patients were treated, how complex their cases were and how closely they were followed. A mean time to hemostasis under a minute is a speed measure, and it is not by itself evidence of fewer bleeding events later.
Why large-bore closure matters
General background, not from the release: large-bore access leaves a bigger hole in the artery than routine catheter procedures, and bleeding or vascular injury at the access site is a recognised complication. Closure devices commonly rely on sutures placed before or after the procedure, so a patch that avoids sutures addresses a clear technical need. Whether it does so better than existing options is a question for comparative data, which the announcement does not provide.
The CE Mark and the Vivasure acquisition
Haemonetics says PerQseal Elite received CE Mark approval in Europe in 2025 for arterial and venous indications. The release also notes that the company acquired Vivasure Medical Limited in January 2026, which expanded its large-bore closure portfolio. We take these points from the release and have not reviewed the CE Mark file. The release describes the U.S. decision in arterial terms and does not mention a U.S. venous indication.
What is not disclosed
- The regulatory pathway behind the U.S. decision.
- Patient numbers and endpoints beyond those cited.
- Pricing, hospital availability and launch timing.
- Head-to-head data against other closure methods.
Risks and caveats on PerQseal Elite
- Safety and performance figures are the company’s own, from a single-arm study.
- A regulatory decision does not show the device is better than alternatives.
- Our explanations of French sizes and large-bore access are general background.
- This is news reporting, not medical or investment advice.
In our assessment, the PerQseal Elite decision matters mainly because it adds a sutureless option at a step of the procedure where hospitals have often relied on sutures, but its place in practice will depend on the full ELITE data and on comparisons that do not yet exist. For the regulator’s general information, see the FDA medical devices pages. See also BPL Medical Technologies Medec Acquisition: Global Bet. More in our medical device coverage.
What to watch next on PerQseal Elite
- Full ELITE arterial results at the TCT conference at the end of October 2026.
- Details of the U.S. regulatory pathway and labelling.
- Launch timing, pricing and hospital uptake.
- Any comparative data against other closure approaches.
Frequently asked questions
What is PerQseal Elite?
A fully bioabsorbable patch from Haemonetics that seals the artery from inside the vessel after large-bore procedures, according to the company.
Was it approved or cleared?
Haemonetics calls it an FDA approval. Some reports describe it as a clearance, and the company release does not state the pathway.
Which procedures does it cover?
Large-bore arterial procedures, including structural heart and endovascular procedures using 14F to 22F sheaths, per the company.
How we reported this: we relied on the Haemonetics release of 19 October 2026 and public regulator pages. Our own calculations and general background are labelled. Last updated: 20 October 2026. This article is news reporting and not medical or investment advice.