CE Mark For Boston’s New Precision Spectra™ 32 Contact Spinal Cord Stimulator System

In short

Boston Scientific Corporation has received CE Mark approval and has begun the European market launch of the Precision Spectra™ Spinal Cord Stimulator (SCS) System, the world’s first and only SCS system with 32 contacts and 32 dedicated power sources.

Background

Chronic pain affects one in five adults in Europe, or about 95 million people 15 to 64 years of age. Without relief, or the hope for relief, many patients lose the ability to sleep, work and function normally.

Designed to manage chronic pain, spinal cord stimulators deliver electrical pulses from an implantable pulse generator to leads with stimulating contacts. These electrical pulses mask pain signals travelling to the brain.

The Precision Spectra System features 32 contacts, offering more coverage of the spinal cord for the management of chronic pain than any other available system. The company says additional lead ports also give physicians more flexibility to treat their patients’ pain at time of implant and more flexibility to adapt to changing pain patterns in the future.

Boston Scientific plans to make significant investment in several clinical trials and build upon its current portfolio of chronic pain management and neuromodulation solutions.

Physician comments

“Over the past 30 years, SCS systems have evolved from four to eight to 16 contacts. At each step, we have seen an improvement in our ability to cover pain,” said first user, Dr. Simon Thomson, Consultant in Pain Medicine and Neuromodulation, at the Basildon and Thurrock University Hospitals in the United Kingdom. “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.”

Company comments 

“The Precision Spectra System is a major milestone in the advancement of SCS therapy,” said Maulik Nanavaty, president of the Neuromodulation business at Boston Scientific. “Our innovation is focused on pain relief and the Precision Spectra System demonstrates our commitment to providing improved pain relief to a broader spectrum of chronic pain patients.”

Regulatory status

The Precision Spectra SCS System is currently under review by the U.S. Food and Drug Administration, and is not available for sale in the United States.

Source: Boston Scientific Corporation, PR Newswire