Innovative catheter-guidewire

Purpose and goal

** Denna text är maskinöversatt ** The purpose is to show a pressure conductor with better properties and better measuring precision than competing products. The goal is to get the product CE approved.

Expected results and effects

** Denna text är maskinöversatt ** All the tests we have performed have shown that our product meets the eligibility requirements we wanted to achieve. Now the product is CE approved and the first clinical evaluation has been carried out, which shows that the product has a unique precision and is safe and efficient to use.

Planned approach and implementation

** Denna text är maskinöversatt ** The product underwent a number of rigorous tests before CE marking. Results were reviewed by the Notified body and the Swedish Medicines Agency, as the product is a drug/device combination product. Due to Covid-19, the hospitals had a ban on visitors to their labs and had to make other priorities, which led to delays before the study started. Sahlgrenska Universitetssjukhuset conducted the study.

External links

Abstract för studien publicerad på världsledande kongress, ESC i Barcelona 2022. Beskrivning av studie innan den startade. Länk till Cavis Technologies AB som är den projektpart som varit huvudansvarig part i projektet.