Last, the drilled devices return to the Singapore facility for testing, hydrophilic coating, assembly, packaging, and sterilization. A qualified contractor in Singapore performs sterilization.

Lessons learned

The design team had to both anticipate and react to issues identified during animal studies and preclinical workups. Studies can take a significant amount of time, so it was important to develop several design variations through design of experiments which could be simultaneously tested. Bench testing per applicable requirements of ISO 14630:2005, EN 14299:2004, and EN 12006:3:2007 also helped fine-tune options. We tested to confirm sterility per ISO 11135 and ISO 10993-7; packaging and shelf life per ISO 11607; magnetic resonance imaging (MRI) compatibility; radiopacity; corrosion resistance per ASTM 2129 and ASTM G71; fatigue; and biocompatibility per ISO 10993- 1:2003. We also performed a battery of bench testing.

The first feasibility study in animals, done in June 2005, identified several needed design changes. More rounds of animal testing were done in November 2005 and March 2006 to dial-in the optimized porosity. Four and nine-month follow-ups and histological exams led to the first human studies in September 2006.

The implant performed well during the human trials, but it became evident that the delivery catheter needed improvement, which was completed prior to the start of our clinical trials. Other enhancements included automating the polymercoating process and improving the crimping of the AOD on the catheter to ensure device integrity as it goes through tight anatomical curves. Merlin MD is presently conducting clinical trials in Spain and Germany and is awaiting approval to begin in Mexico this summer. The Singapore agencies were instrumental in opening these potential markets to us.