In December 2023, Edwards Lifesciences won a court case in Delaware.
Edwards will no longer have to pay the $300 million in outstanding Cardioband milestones to Valtech Cardio owners.
The decisive factor in the verdict was the inadequacy of the product, in which important product information was obviously withheld.
On July 31, another ruling followed, this time from the Supreme Court in Delaware. The court confirmed that a statement made by Edwards in the quarterly report dated April 29, 2024, which was also sent to the Securities and Exchange Commission, was justified.
Precisely zero percent (Delaware)
Namely, that the probability of reaching the next milestone with the Cardioband product is “zero percent”.
The final finding shows the extensive uselessness of the implant, which was largely developed at the University Hospital of Zurich.
This was under the leadership of the then director of cardiac surgery and the hospital’s chief operating officer and their supporters.
Back then, patients were a means to an end to hype up a piece of metal wire so much that it could be touted and sold to a medtech company for hundreds of millions of dollars.
In order for the project to be successful, intensive marketing strategies were developed early on in collaboration with the agency “Natie”.
The aim was to nip any doubts in the bud, even though they were more than justified. Critics were silenced and branded as supposedly incompetent.
The Million Bucks Wire (Nation)
The wire called “Cardioband” was attached to the area of the heart valve in humans, although its functionality and attachment were already more than questionable in advance.
Results were glossed over and complications were omitted.
After the money had been spent, the product gradually disappeared into obscurity. The CE certification that was crucial for sales no longer exists.
In the end, the cardio band was discontinued and taken off the market.
Apart from the harm to the patient, an invasive procedure that demonstrably does not benefit the patient already constitutes avoidable bodily harm.
In the case of those who underwent cardioband surgery, potentially promising therapies were either withheld from those affected or were only implemented at a late stage.
The German Heart Foundation responded to concerned patient inquiries about the use of the Cardioband that
“Changes in the valve leaflets or the damaged tension on the valve leaflets by tendon threads attached to the ventricle played the decisive role in valve leakage” and “less the widening of the valve annulus”.
“For this reason, the Cardioband system for the mitral valve is currently no longer used.”
The Heart Foundation is correct about the cause of the valve leakage. But the crucial point is that this finding is not new; it has been known for decades.
In other words, the Cardioband was implanted into the mitral valve of more than 150 patients at the Zurich University Hospital, where I was working as senior physician at the time, as well as at other European clinics.
Although it could never work.
What those responsible for the Cardioband had to be clear about before it was first used on patients.
Added to this is the inadequate fastening mechanism of the wire; those responsible should have known this in advance.
Screw tearing was inevitable and it happened promptly. Instead of stopping the exercise immediately, the doctors in charge ignored the complications.
The details of the technical problems surrounding the Cardioband can be found in the article “Versuchslabor Herzchirurgie Zürich”.
The facts have been on the table in detail for almost five years after I reported the grievances to my employer.
Since then, everyone knows: The Cardioband Mitral product should never have been used on humans.
Now Cardioband buyer Edwards has won two court cases, one in December 2023 and the most recent in July 2024.
In view of the successes achieved, will Edwards Lifesciences demand back the $340 million for the trade sale and the $50 million for the first milestone payment?
In this case, the university hospital also has to worry. Without it, the hospital director at the time and his network that protected him would never have been able to turn the cardio band into gold.
