Occlutech tests heart implant | Greater Zurich

The Schaffhausen-based company Occlutech Holding AG has been given the green light to carry out a study with its Flex II patent foramen ovale occluder in the USA. For this, the firm received conditional approval from the U.S. Food and Drug Administration (FDA), further details of which can be found in a press release.

Patent foramen ovale (PFO) is a structural heart defect. The foramen ovale does not close completely after birth, which leads to a valve opening between the left and right atrium of the heart. This allows blood clots to block small blood vessels in the body, which in certain cases can also lead to a stroke. The PFO occluder developed by Occlutech is used to close this valve opening.

As part of the study, the company’s PFO occluder will be compared against standard treatment approaches for PFO closure in cryptogenic stroke patients – this refers to stroke cases with an unknown cause. Patient enrollment is to start in the current year.

“We assume that we will be able to complete the recruitment of patients in 2025 while we are completing the pre-market approval, and we expect FDA market approval in the USA in 2026”, comments Sabine Bois, CEO of Occlutech, in the press release.

The occluder from Occlutech has already been approved for use in more than 60 markets around the world. “The conditional approval from the FDA is another important milestone in our plan to gain a foothold in the USA”, Bois explains. With a share of around 30 percent of the global market for closures of structural heart defects and an “attractive price and reimbursement system”, the USA is potentially a key market for Occlutech. At the beginning of the year, the company established a subsidiary in Chicago, which focuses on marketing, distribution, logistics and sales.