Medtronic’s first-of-its-kind brain implant could close the loop

The first of Medtronic’s Activa line of deep brain stimulation (DBS) devices gained FDA approval in 1997 and since then the field has expanded hugely. This expansion could now accelerate following the start of US trials of the Activa PC+S DBS system, which not only treats the symptoms of Parkinson’s disease but also senses electrical activity in the brain – the first time this has been possible.

Medtronic says Activa PC+S could become the standard of care when it reaches the market. But it is as a step towards a “closed-loop” system – one that senses where electrical impulses are required and delivers them to order – that the device’s true worth lies.

Medtronic will implant the first Activa PC+S in a US patient in the coming months. The data collected over the coming months and years will go towards developing an algorithm to connect the sensor with the stimulator, interpreting the electrical changes in the brain and converting them into the correct response. As impulses vary from person to person, such a system’s behaviour would be unique to the patient.

It is even possible that a closed-loop system could prevent events; in the case of epilepsy, for example, it could react to changes that herald a seizure, heading off the attack before any external signs appear.

Sales growth to slow

If Activa PC+S allows Medtronic to get the jump on its rivals in terms of innovation and, more importantly, translate this into increased sales in the next five years or so, it will come as something of a relief to the company. In its full-year 2013 results, the Minneapolis company recorded neuromodulation revenues of $492m, an increase of 7% on the previous year, with analysts from Deutsche Bank noting a double-digit uptick in sales of the DBS franchise in both the US and elsewhere during the quarter to April 26, 2013.

However, EvaluateMedTech’s consensus forecasts show that this state of affairs will not continue. In the US, Medtronic's DBS annual sales growth will fall from 10% in 2013 to a low of just 1% in 2016.

The FDA is not renowned for its swiftness at waving innovative implanted devices through. Two of Medtronic’s previous DBS systems obtained humanitarian device exemption (HDE), generally a quicker route to market (see table). This could bring hope that Activa PC+S could reach the US in a few years’ time, helping arrest the growth slide.

After that, perhaps Medtronic will find development of these systems easier, cheaper and faster as it exploits the data gathered from use of Activa PC+S.

Medtronic's marketed DBS systems
Device name Indication FDA approval PMA/HDE number EU approval (CE mark)
Activa Essential tremor 31 July 1997 P960009 31 December 1993
Activa Dystonia 15 April 2003 H020007 31 August 2008
Reclaim Chronic, severe obsessive compulsive disorder 19 February 2009 H050003 1 July 2009
Activa RC Parkinson's disease/essential tremor 30 April 2009 P960009 31 August 2008
Activa PC Parkinson's disease/essential tremor 30 April 2009 P960009 31 August 2008
Activa SC  Parkinson's disease/essential tremor 26 January 2011 P960009 -
Activa PC+S  Parkinson's disease/essential tremor/dystonia/epilepsy - -  January 2013  

All data sourced to EvaluateMedTech

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizEPVantage on Twitter

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