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“The Bladder Control System gave my life back to me”Amanda Boxtel
 
“My bladder does not dominate my life anymore”.
Jo Wright
 
“I can’t remember when I last had a UTI” Lesley
 
"The number of infections that I have had since implanting this device can be counted on the fingers of one hand" Martin

 

What is an Active Implantable Medical Device?

The definition of an active implantable medical device given in the Directive (AIMD 90/385/EEC as amended by 2007/47/EC) is as follows:


Active Medical Device means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

Active Implantable Medical Device means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;


Examples of AIMDs include:

  • Implantable cardiac pacemakers
  • Implantable defibrillators
  • Implantable nerve stimulators
  • Bladder stimulators
  • Diaphragm stimulators
  • Cochlear implants
  • Implantable active drug administration device
  • Implantable active monitoring devices

Finetech Medical manufacture devices which are classified as active implantable medical devices under AIMD 90/385/EEC as amended by 2007/47/EC.

The Finetech Brindley Bladder Control System

The Finetech Brindley Bladder Control System (branded as VOCARE in the US) is intended for restoration of bladder function after complete spinal cord injury. Secondary functions include the aiding of bowel evacuation and penile erection.  

Spinal cord injuries patients can benefit from this system to:-

  1. Restore bladder control
  2. Bowel evacuation
  3. Penile erection

STIMuSTEP Dropped Foot Stimulator

The Finetech Medical's STIMuSTEP system is an implanted neuromuscular stimulator that uses functional electrical stimulation (FES) to help correct dropped foot condition. This allows independent control of dorsiflextion  (lifting the foot) and eversion (rotate ankle to the correct position), which correcting the abnormal movement of the affected foot during the swing phase of gait.

The STIMuSTEP gives a range of benefits for users, including:

  • Easier to walk
  • Less likely to trip or fall
  • Increased walking speed
  • Increased walking range
  • Improved joint movement
  • Improved ankle stability
  • Improved muscle bulk/tone
  • Improved local blood flow
  • Enhanced quality of life
  • Greater safety, confidence and independence
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What is an Active Implantable Medical Device?
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