Lifesaving surgery technique with a new catheter balloon at circular collapse

Purpose and goal:

We have developed prototypes of an aortic balloon for minimally invasive treatment of circulatory collapse. The prototypes have been evaluated in vitro and in vivo and we now have a locked design. Due to challenging prototyping with delays in delivery of materials, we have not met the goals of completed biocompatibility testing and packaging.

However, with positive results from functionality tests, we have good opportunities to proceed with remaining activities and prepare for a clinical study after the end of the project. Expected results and effects:

The prototypes produced have given good results in functional tests in vitro and in vivo. We now have a locked design of the product with reports that will be included in the regulatory documentation. The market study carried out will be used for the upcoming commercialization and the results are expected to lead to one or more patent applications. After the project is completed, we plan to take the prototypes further for the final tests and documentation to be able to conduct a clinical study.

Approach and implementation:

A requirements specification based on interviews of surgeons and literature studies led to prototypes that were functionally evaluated in a lab environment and a relevant animal model and led to a locked design of the product. Due to material delays and protracted process to get to the final prototypes, biocompatibility, sterilization and packaging have been delayed.

However, these are standardized tests that can usually be done within a limited time. With the good results we got from the project, we will take the product further towards clinical study after the end of the project.