Swissmedic approved heart implant without asking about safety

Swissmedic allowed an experimental heart implant to be used at University Hospital Zurich without asking the hospital or manufacturer about the device’s safety, an SRF Investigativ investigation has found.

The implant, called the Cardioband, was developed in part by heart surgeon Francesco Maisano. It was designed to tighten a leaking heart valve. In 2016, the University Hospital Zurich (USZ) described itself as a pioneer in heart-valve medicine and Maisano called the treatment safe in a press release. But during the first implantation, the wire broke and the patient’s valve remained leaky. Surgeons placed a second Cardioband over the first.

The device was in the highest risk class and did not have CE certification. It had also never been tested in people for use on the right heart valve. The hospital therefore needed an exemption from Swissmedic, the national therapeutic products authority, to carry out the experimental procedure. Records obtained by SRF under the Freedom of Information Act show that the authority granted the exemption without asking the hospital or manufacturer questions about the product’s safety.

Jörg Goldhahn, an ETH professor in health sciences and technology, told SRF that Swissmedic had effectively waived its review, which he said was incompatible with its mandate. Swissmedic said it performs its legal duties in a risk-based and proportionate way. The authority also said that time pressure can make it difficult to assess exemption applications fully, and that responsibility for using a product without proof of conformity in a medical emergency ultimately lies with the practitioner.

Goldhahn disputed that argument, saying the permit requirement would be pointless if responsibility rested solely with doctors. Heart surgeon André Plass, who helped bring the USZ scandal to light, also rejected the emergency justification. Leaking heart valves are generally chronic conditions, he said, giving the authority time to make checks. The records reviewed by SRF contain no indication that Swissmedic independently assessed the urgency of the procedure.

SRF also found that the hospital did not report the complication through the prescribed system for serious incidents, instead informing Swissmedic in a treatment report. The manufacturer did not report the complication or provide an analysis of its cause. Internal emails indicate that Swissmedic knowingly tolerated this. In an August 2016 email, one inspector wrote that the authority’s intention had been not to be “too persistent” in this case.

Maisano led the USZ heart clinic from 2016 to 2020, a period in which more than 70 unexpected deaths occurred at the hospital. An administrative investigation published in May 2026 found serious shortcomings and concluded that the use of innovative products, including Cardiobands, was inappropriate in 13 cases. It also cited selective reporting of results and the omission of serious complications from scientific publications. The report said conventional surgery would probably have produced better outcomes for the patients. Maisano held stock options in the Cardioband’s manufacturer.

The USZ hospital board said it would refer 11 unexpected deaths and the 13 inappropriate uses of medical devices to the Zurich public prosecutor’s office. Cardioband’s manufacturer withdrew the device from the market in 2024.