Edwards Lifesciences confirmed Tuesday that EU officials conducted an unannounced inspection at company premises in Europe last week to investigate antitrust concerns.
The Irvine, California-based maker of artificial heart valves and other medical devices did not provide further details about the inspection but said it is cooperating in the matter.
"Edwards Lifesciences is cooperating with the European Commission regarding its inspection in relation to EU competition law. We have an unwavering commitment to healthy, fair competition; when innovative companies like ours compete, patients benefit. We remain confident in our business practices and will not be commenting further at this time," Edwards spokesperson Amy Hytowitz said Tuesday in an email.
The European Commission last week said it carried out a surprise inspection at an unnamed cardiovascular device company suspected of violating rules against abuse of a dominant market position. Reuters first reported that Edwards was the target of the EU inspection.
Unannounced inspections are an initial step in investigations of suspected anticompetitive practices in the EU, and companies have the right to be heard in antitrust proceedings.
In recent years, EU antitrust regulators have made unannounced inspections across a range of industries, including fashion, food and automotive. In the medtech sector, EU officials have taken a hard line against gene sequencing company Illumina, imposing a 432-million-euro fine for closing the 2021 acquisition of cancer test developer Grail without first gaining the commission’s approval.