1 – The Freehand System

The Freehand System

Salisbury, Award: c £400,000, Start of Trial: 6 Jun 95

The Freehand System is an implanted FES (Functional Electrical Stimulation) device intended for the restoration of hand function in C5 and C6 level tetraplegics.

Following training and gaining the necessary clearances, the first Freehand at a cost of $24,000 (about £16,800) was implanted and is still being used today. The user would proudly tell you that he is now able to open a bottle of wine! INSPIRE was authorised by the then MDA (Medical Devices Agency) to implant 20 systems and it was agreed that the Spinal Unit at Southport should do three and Salisbury 17. In fact the overall total would have been more because Scotland purchased two but the American company responsible for making and distributing the Freehand ran into financial difficulties during 2001 and all operations relating to Freehand stopped. INSPIRE never completed its trial (16 were implanted) and it was a cruel blow to hit C5/C6s, some of whom were looking forward to being given the device.

INSPIRE remains keen to continue with the ‘son’ of Freehand but there have been complications in the US, some relating to the recovery of IPR. This has now been done and the system has been redesigned, improved and should offer more functions such as bladder management or offered to C4s. The first implant of this new system is expected by the end of 2007 in the States.

European agencies are looking at producing their own version.