Boston Scientific’s CoverEdge surgical leads secure FDA and CE Mark approval

22 October 2014 (Last Updated October 22nd, 2014 18:30)

Boston Scientific have secured US Food and Drug Administration (FDA) and CE Mark approval for its CoverEdge 32 and CoverEdge X 32 surgical leads, which will be used to treat spinal cord pain.

Boston Scientific have secured US Food and Drug Administration (FDA) and CE Mark approval for its CoverEdge 32 and CoverEdge X 32 surgical leads, which will be used to treat spinal cord pain.

Powered by Illumina 3D software, the CoverEdge surgical leads have been developed for use with the Precision Spectra Spinal Cord Stimulator (SCS) system.

Illumina 3D Software is a proprietary, anatomy-based computer model for precise pain targeting.

The company said CoverEdge surgical leads offer 32 contacts and helps to deliver focused coverage of the spinal cord for more pain relief, while previous surgical leads have delivered pain therapy with a maximum of 16 independent contacts.

"Powered by Illumina 3D software, the CoverEdge surgical leads have been developed for use with the Precision Spectra Spinal Cord Stimulator (SCS) system."

The CoverEdge 32 surgical lead, available in two configurations, offers the broadest span on the market among multi-column paddles and features 32 tightly spaced contacts in four columns for precise pain targeting.

According to the company, the combination of the CoverEdge surgical leads with the Precision Spectra SCS system and Illumina 3D software is designed to deliver spinal cord stimulation in new ways.

Boston Scientific neuromodulation president Maulik Nanavaty said: "The new CoverEdge surgical leads allow surgeons to utilize the full potential of our innovative Precision Spectra SCS system and offer their patients an opportunity for excellent pain relief.

"The introduction of the Precision Spectra system in 2013 has changed the way many physicians treat their patients with chronic pain."

The company plans to introduce CoverEdge surgical leads at the Congress of Neurological Surgeons (CNS) this week in Boston.