Boston Scientific (NYSE:BSX) said it won FDA and CE Mark approval in Europe for its CoverEdge 32 and CoverEdge X 32 surgical leads, touting them as the world’s 1st 32-contact leads for treating chronic pain.
The CoverEdge leads are designed to be used with Boston Scientific’s Precision Spectra spinal cord stimulator, according to a press release.
The leads offer twice the number of electrical contacts as standard leads, a feature designed to "blanket" the spinal cord to provide pain relief, the company said.
"I see the CoverEdge Surgical Leads as a game changer for patients," Dr. Giancarlo Barolat of Denver’s Barolat Neuroscience said in prepared remarks. "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 CoverEdge leads are also designed to be used with Boston’s Illumina 3D modeling software "to deliver spinal cord stimulation in new ways," the company said.
"For example, a key challenge in SCS 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 SCS leads, the Illumina 3D software is designed for simple point-and-click pain targeting."
"At Boston Scientific, we are dedicated to advancing the science of pain relief," neuromodulation president Maulik Nanavaty said in a statement. "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."