Boston Scientific Gets FDA Approval and CE Mark for Surgical Leads for Spinal Pain

Boston Scientific Corp. received U.S. Food and Drug Administration (FDA) and CE mark approval for the CoverEdge 32 and CoverEdge X 32 surgical leads for spinal pain.

According to the company, the systems are the world’s first 32-contact surgical leads designed to blanket the spinal cord for pain. Designed for use with the Precision Spectra spinal cord stimulator (SCS) system, CoverEdge surgical leads are powered by Illumina 3-D software, a proprietary, anatomy-based computer model for precise pain targeting.

Boston Scientific introduced the CoverEdge surgical leads at the Congress of Neurological Surgeonsin Boston, Mass., on Oct. 21.

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,” said Giancarlo Barolat, M.D., medical director of Barolat Neuroscience in Denver, Colo. “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 SCS system and Illumina 3-D software is designed to deliver spinal cord stimulation in new ways, according to the company.For example, a key challenge in SCS therapy is stimulating the neural target without stimulating undesired areas. By taking into account the conductivity of 3-D anatomical structures and physician placement of the SCS leads, the Illumina 3-D software is designed for simple point-and-click pain targeting.

“At Boston Scientific, we are dedicated to advancing the science of pain relief,” said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. “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.”

More than 100 million Americans suffer from chronic pain. Spinal cord stimulators deliver electrical pulses from an implantable pulse generator to leads with stimulating contacts. The contacts provide pain relief by masking pain signals traveling to the brain.

In 2004, Boston Scientific launched the world’s first rechargeable SCS device, the Precision system, which was also the world’s first 16-contact implantable SCS device.

Boston Scientific is based in Marlborough, Mass.