New Endovascular Technique

Purpose and goal

The aim of the project was to: Ensure preclinical safety for clinical trials. Prepare a Technical file/Design dossier ´. Identify the first clinical application. Prepare a business plan for financing and company formation. All activities were carried out during the project and expected goals where achieved period.

Results and expected effects

Safety of the device after chronic deposit in the vascular wall was examined preclinical. A 12 month safety study was conducted in 10 pigs each operated with 2-3 devices. Animal welfare was followed, 12 months angiography was performed, animals were sacrificed and the tissue around the device was examined. No side effects were detected; the method can be regarded as safe. Clinical studies in the two identified areas are planned. Results are documented in a regulatory format. A business plan is developed. Discussions for a company formation are ongoing with MedTech and investors.

Approach and implementation

The project is a collaboration between Karolinska Institutet Innovations AB and inventors at Karolinska Institutet and KTH. KIAB acted as project manager, business developer and administrator. The inventors made prototype development, production of 0-series and carried out scientific and preclinical studies within their areas of expertise in materials technology and medical/clinical science. External consultants have been hired for animal care, regulatory, patent/IP and business development.