Boston Scientific wins CE mark for spinal cord stimulator system

10 December 2012 (Last Updated December 10th, 2012 18:30)

The European Union has granted CE mark approval to Boston Scientific's spinal cord stimulator (SCS) system, designed to provide improved pain relief in chronic pain patients.

Boston Scientific

The European Union has granted CE mark approval to Boston Scientific's spinal cord stimulator (SCS) system, designed to provide improved pain relief in chronic pain patients.

The Precision Spectra system, which the company claims is the world's first and only SCS system with 32 contacts and 32 dedicated power sources, has four lead ports that offer more coverage of the spinal cord for the management of chronic pain.

The lead ports provide physicians with more flexibility to treat patients' pain at time of implant and adapt to changing pain patterns in the future.

Equipped with an implantable pulse generator, the SCS delivers electrical pulses to leads with stimulating contacts and mask pain signals travelling to the brain.

To study the efficacy of the system, the first implant was performed at the Basildon and Thurrock University Hospitals in the UK.

Basildon and Thurrock University Hospitals pain medicine and neuromodulation consultant Dr Simon Thomson said previously, the SCS system was having four to eight contacts.

"Now, by doubling the number of contacts to 32 while providing a dedicated power source for each contact, the Precision Spectra System advances our ability to provide pain relief," Thomson added.

"The first implant was performed at the Basildon and Thurrock University Hospitals in the UK."

To further characterise the benefits of 32 contact option in Precision Spectra, the company has begun a prospective, multi-centre, single arm study named OPTIONS trial.

Boston Scientific has initiated a cross-sectional, multicentre MAP trial to identify the prevalence of multiple areas of pain in SCS-eligible patients with certain diseases.

Boston Scientific said that the new SCS system is currently under review by the US Food and Drug Administration and is not available for sale in the US.


Image: Boston Scientific's corporate headquarters in Natick, Massachusetts, US. Photo: courtesy of BostonScientific.