Pre-clinical and Clinical Testing
Pre-clinical Testing
Early input was obtained in 2004 from a focus group of 25 surgeons and OR nurses. Surgeons were from academic and non-academic hospitals from various regions in the Netherlands. Feedback from these end-users served as key input for the initial and ongoing design improvements.
Pre-clinical testing on desktop models and fresh animal cadavers has been performed. In total over 60 surgeons in the Netherlands and USA have been involved in the pre-clinical testing to date.
Institutions participating in SutureAid evaluation to date:
- The AMC, Amsterdam, the Netherlands
- Johns Hopkins Medical Institution, Boston
- Massachusetts General, Boston
- OLVG, Amsterdam
- MST, Enshede, the Netherlands
- Northwestern and University of Chicago, Chicago
Clinical Testing
Clinical testing has been performed in 3 hospitals in the Netherlands mainly by vascular surgeons, cardiovascular surgeons and gastro-intestinal surgeons. In over 120 procedures, using various SutureAid forceps and Needle Receptors were tested. SutureAid products performed to satisfaction and no failures were reported. Use of SutureAid products was found to be effective, safe and without side effects.
