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Track record on medical devices

  • Aug-2007: Early feasibility on registration study for medical device in China.

  • 2007-2010: PMA registration study for a Danish medical device company. Multi-centre study in 7 centres in the US, including 192 patients.

  • 2007-2009: PMA registration study for Danish medical device company. Multi-centre study in 10 centres in the US, enrolling 190 patients.

  • 2006-2010: Phase IV multinational multi-centre trial in 51 centres in DK,NO,SE;FI with 380 patients ) currently in the recruitment phase.

  • 2004-2009: Phase IV Multinational multi-centre trial in 60 centres in 8 countries (DK,NO,SE,FI,BE,CH,UK,NL) including 384 patients enrolled.

  • 2005-200?: Multinational safety and efficacy trial on Danish medical device product. 7 participating countries, 10 centres and 120 patients included.