NEW PRODUCTS & TECHNOLOGY

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New spinal cord stimulator system gets regulatory nod

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 Precision Spectra System is the world's first and only SCS system with 32 contacts and 32 dedicated power sources and is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain.

The first commercial implant of the Precision Spectra System was performed last month by Dr. Simon Thomson, Consultant in Pain Medicine and Neuromodulation, at the Basildon and Thurrock University Hospitals in the United Kingdom.

Chronic pain affects one in five adults in Europe, or about 95 million people 15 to 64 years of age. Living in constant pain for an extended period of time can have a devastating impact on quality of life for many patients. 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 traveling to the brain.

Until now, SCS systems have offered a maximum of 16 contacts and two lead ports, with each lead port allowing the placement of one lead. By providing 32 contacts and four lead ports—twice that of any other SCS system—the Precision Spectra System offers more coverage of the spinal cord for the management of chronic pain.

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.

"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 Dr. Thomson. "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."

"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."

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

The company has recently begun the following trials:
• OPTIONS Trial: A prospective, multi-center, single arm study to further characterize the benefits of having a 32 contact option using the Precision Spectra System.
• MAP Trial: A cross-sectional, multicenter study to identify the prevalence of multiple areas of pain in SCS-eligible patients with certain diseases.

In addition to the Precision Spectra System, the Boston Scientific Neuromodulation business has recently launched several new products and has received expanded regulatory indications for products approved in Europe.

These include:
• Head-only MRI Conditional CE Mark Approval for the Precision™ Plus SCS System
• Peripheral Nerve Stimulation CE Mark Approval for the Precision Plus SCS System
• Vercise Deep Brain Stimulator System CE Mark Approval for Parkinson's Disease
• Infinion 16 Percutaneous Lead for SCS

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

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