Doctors around the world are urgently looking for a minimally invasive solution to treat more than 300,000 patients a year suffering from severe tricuspid regurgitation, many of whom are likely to die because there is currently no treatment option. TRiCares has taken on this technological challenge to develop a safe and effective medical device.
The new heart valve, made from biological tissue from pigs, is sewn by hand onto a scaffold made from a special nickel-titanium alloy. For implantation, this heart valve is inserted into a catheter that has been specially developed and manufactured by TRiCares for this application.
TRiCares has already completed the majority of the tests required by the regulatory authorities and the first trials in Europe have already begun. Over a dozen patients are already living with the Topaz valve from TRiCares. The success is unique. Patients who were too weak to walk independently were even able to climb stairs without assistance after a short time. A puncture in the groin is all that remains visible externally after implantation, compared to a large scar on the chest with the conventional method. The new implantation technique, which is very gentle on patients, means that they can ideally be discharged from hospital after just a few days.
As soon as the necessary clinical trials have been completed and authorisation has been granted by the authorities, all patients suffering from this disease can be treated, especially those for whom open heart surgery is too risky.
