Development of a device to protect against cerebral embolizations during cardiac interventions and operations.
| Reference number | |
| Coordinator | CONTEGO AB |
| Funding from Vinnova | SEK 2 000 000 |
| Project duration | September 2013 - September 2016 |
| Status | Completed |
Purpose and goal
Development of a cerebral protection device to be used in conjunction with heart interventions and heart surgery - We have succeeded in conceptually, anatomically, functionally and experimentally verifying the concept of a system that provides protection against cerebral embolisation during heart interventions, and finally defined a specification for a clinical product.
Results and expected effects
In addition to verify the concept of a protection against cerebral embolisations, we have defined and tested a design that works in a human anatomy, fits into the clinical workflow in conjunction to a heart intervention or surgery, and can be placed in the aortic arch in an atraumatic way. The design we have chosen provides, in addition to protection against cerebral embolisation, also mechanical support in conjunction with implantation of an artificial heart valve.
Approach and implementation
The work has been divided into the following phases; Defining the technical solution, choice of collaboration partners for the development and prototyping, testing suitable materials in collaboration with our partners, development of the first prototypes, testing the prototypes in a heart model, based on these tests develop a second generation prototypes, testing this new generation in an animal model, and as a last step define a specification of a final clinical product as well as methods for verifying its performance in a clinical study that result in a CE certification.