Vivasure Medical's EIC Accelerator Vein Closure Patch, 7 Years On

Heart valve repairs and other catheter procedures that reach the heart through the femoral vein leave a hole in the vein of 8 millimetres or more, too large to close reliably by pressing on the groin. Vivasure Medical, a Galway company that already made an absorbable patch for closing large holes in arteries, won an EU grant of €2,499,999 in the October 2019 round of the EIC Accelerator pilot to adapt that patch for veins, according to CORDIS. Seven years after the cut-off, the device is CE-marked in Europe for both arteries and veins, and the company belongs to Haemonetics, a US medical device group, which completed the purchase on 9 January 2026 for an upfront €100 million, according to its press release and its quarterly filing with the US Securities and Exchange Commission.

The EIC project itself is a more mixed story. By its end in March 2023 the venous device had been designed, built on a production line and tested in animals and on the bench, but it had not been used in a patient. The first venous patient was treated in April 2024, the European venous approval came in June 2025, and no US application for the venous use has been announced.

Where Vivasure Stands Now

Vivasure is a subsidiary of Haemonetics. The Irish company still exists: the companies register lists Vivasure Medical Limited with status "Normal", accounts filed for 2024 and a series of director changes in January, February and May 2026, according to SoloCheck, which reads the Companies Registration Office records. Its website now carries the line "Vivasure Medical is now a part of Haemonetics" and states that PerQseal Elite is "CE Mark approved. Not available for sale in the United States", according to vivasuremedical.com.

Haemonetics paid €100 million upfront, which it put at about €52 million net of "certain previous investments and other loans" it had already made to Vivasure, and agreed to pay up to €85 million more "based on sales growth and the achievement of certain other milestones", according to the announcement reported by Cardiac Interventions Today. Its SEC filing puts the net purchase price at $166.1 million and shows that it already held about 30% of Vivasure before the deal, a stake valued at $47.3 million.

The deal is still paying out. Orchestra BioMed, a Nasdaq-listed company that had held Vivasure since its own formation, said it received about $5 million at closing and a first milestone payment of $6.1 million on 14 September 2026, and that it can receive up to about $10 million more from revenue earnouts, according to Endovascular Today. Neither Orchestra nor Haemonetics has said publicly which milestone triggered the September payment.

The Technology: Closing the Hole From the Inside

Transcatheter valve replacement, mitral and tricuspid repair and left atrial appendage occlusion are done through a large sheath pushed into the femoral artery or vein. Small punctures are closed by hand pressure. Large venous ones are hard to close that way, so clinicians often call in a vascular surgeon, and the VENOCLOSE report on CORDIS lists the costs: a surgical team, extra anaesthesia, longer hospital stays and a higher risk of infection, thrombosis and vessel damage.

PerQseal works differently. The device places a synthetic patch inside the vessel against the puncture, sealing it from the inside without sutures, and the patch is absorbed over time. PerQseal Elite, the version that is now CE-marked, closes punctures up to 26 French in arteries and veins, keeps a 0.035-inch guidewire in place in case the operator needs to regain access, and needs no step before the main procedure, according to Haemonetics' filing and the company's product page. The venous version funded by the EIC was, in the words of the CORDIS summary, "largely based on Vivasure's already existing and well-validated PerQseal Arterial product", which already had a CE mark when the company applied.

What VENOCLOSE Promised, and What CORDIS Shows

Vivasure appears under its own name, on a single row, in the European Commission's list of companies selected at the 9 October 2019 cut-off, as a grant-only winner with no partner company. The grant agreement was signed on 14 April 2020 and the project ran for 35 months, from 1 May 2020 to 31 March 2023, under the Horizon 2020 SME instrument topic. CORDIS lists no other EU research project for the company.

The application promised "clinical validation and preparation for EU and US wide commercialisation" of PerQseal Venous, the CORDIS objective says. The final report narrows the goal: "to design, develop and manufacture a Venous closure device for a First in Human study." It reports that the project, which started at the height of the Covid-19 pandemic, finished product design, chose materials and suppliers, filed patents in the PCT and US systems, built and commissioned a manufacturing line, and completed design verification, biocompatibility, sterility and validation testing, with key cardiologists using the device in animals. It does not report any use in humans, and the page was last updated in June 2024.

1. Design and manufacture the venous deviceDeliveredProduction line set up and all verification testing completed, per the final report.
2. First-in-human useLateNot reached by March 2023; first venous patient treated in April 2024 in the ELITE-Venous study.
3. European approval for venous closureDeliveredCE mark for the venous indication, June 2025, two years after the project ended.
4. US commercialisation of the venous deviceNot achievedThe 2025 PMA application covers arterial closure only; no US venous filing announced.

The clinical work came after the grant. Vivasure treated its first large-bore venous patient at the Erasmus Medical Centre in Rotterdam in April 2024, in the ELITE-Venous study, which planned to enrol up to 97 patients at up to 12 European sites, according to Cardiac Interventions Today and DAIC. By October 2024 the ELITE and ELITE-Venous studies together had enrolled about 100 patients at 12 sites, the company said ahead of the TCT 2024 conference. The venous results have not been published in a form that could be checked for this article. On 24 June 2025 Vivasure announced CE approval for "an expanded indication" covering large-bore venous closure, according to Endovascular Today.

Along the way the venous product changed shape. In May 2022 Vivasure still listed a separate venous device, PerQseal Blue, next to PerQseal and PerQseal+ for arteries, according to its Series D announcement. The approved product is a single system, PerQseal Elite, for both kinds of vessel.

What Vivasure Achieved Since the Award

The larger story of the period was the arterial device. In March 2023 the US Food and Drug Administration approved an investigational device exemption for PATCH, a pivotal study of PerQseal for large-bore arterial closure planned for up to 188 patients in the US and Europe, and Haemonetics put €30 million into the company's Series D, with an option to buy it once certain milestones were met, according to BioSpace and Silicon Republic. Orchestra BioMed says the pivotal trial met its primary safety and efficacy endpoints, according to its account of the Vivasure investment. PerQseal Elite won its arterial CE mark in April 2025, the arterial ELITE study reported 0% major complications at 30 days, and Vivasure filed for US premarket approval for the arterial indication in 2025. No FDA approval had been announced by early October 2026.

The EIC grant arrived in a company that was already well financed. CORDIS records that Vivasure had raised €45 million by the time of its application. It had raised €16.2 million in a Series C in 2016, according to MedNous, and borrowed €10 million in venture debt from the European Investment Bank in September 2019, according to Galway Bay FM. It also received €750,000 in Covid-19 state aid under Ireland's Sustaining Enterprise Scheme in October 2020, according to North Data. The company is not in the EIC Fund portfolio, which fits a grant-only award.

The Money

Vivasure's accounts are filed in Ireland, but its revenue, losses and staff numbers are not freely available, so they could not be checked for this article. The best view of the business at the moment of the sale comes from the buyer. Haemonetics valued the developed technology at $117.1 million and recorded $52.2 million of goodwill. It took over $1.06 million of inventory and just $21,000 of accounts receivable, a sign that European sales, planned to start in the summer of 2025 according to Endovascular Today, were still very small. The buyer was paying for a patent-protected device and its trial data, not for an existing revenue stream.

Why Europe Should Care

Cardiovascular disease is the EU's leading cause of death, and in December 2025 the Commission adopted its first plan dedicated to it, the Safe Hearts Plan, which asks every member state to have a national cardiovascular health plan by 2027, according to DAIC, reporting the European Society of Cardiology's response. Catheter-based valve treatments are a growing part of that care, and a device that lets them be finished without a surgeon fits the plan's emphasis on access to innovative treatment. The EU backed Vivasure twice, through the EIB loan and the EIC grant.

The sale also shows the limit of that support. The technology was developed in Ireland with European public money, but its future, including whether the venous indication is ever filed in the United States, is now decided by its US owner.

The Verdict

Vivasure Medical and Haemonetics have not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.