FDA and CE mark approval for new CoverEdge surgical leads


Boston Scientific has received US Food and Drug Administration (FDA) and CE mark approval for the CoverEdge 32 and CoverEdge X 32 surgical leads, the world’s first 32-contact surgical leads designed to blanket the spinal cord for unprecedented pain coverage. Designed for use with the Precision Spectra spinal cord stimulator system, the CoverEdge surgical leads are powered by the Illumina 3D software, a proprietary, anatomy-based computer model for precise pain targeting. Boston Scientific is introducing the CoverEdge surgical leads at the Congress of Neurological Surgeons (CNS).

Previous surgical leads have delivered pain therapy with a maximum of 16 independent contacts. By offering 32 contacts – each powered by a dedicated power source – CoverEdge surgical leads are designed to deliver more focused coverage of the spinal cord for more pain relief. Available in two configurations, the CoverEdge 32 surgical lead features 32 tightly spaced contacts in four columns for precise pain targeting. The CoverEdge X 32 surgical lead offers the broadest span on the market among multi-column paddles.   

“I see the CoverEdge surgical leads as a game changer for patients,” says Giancarlo Barolat, medical director of Barolat Neuroscience in Denver, USA. “Because it provides greater coverage of the spinal cord, I believe this product will give patients, especially those with low back pain or pain in multiple areas, a better opportunity for relief.”

The combination of the CoverEdge surgical leads with the Precision Spectra spinal cord stimulator system and Illumina 3D Software is designed to deliver spinal cord stimulation in new ways. For example, a key challenge in spinal cord stimulation therapy is stimulating the neural target without stimulating undesired areas. By taking into account the conductivity of 3D anatomical structures and physician placement of the spinal cord stimulator leads, the Illumina 3D Software is designed for simple point-and-click pain targeting.