Precision(TM) Plus Spinal Cord Stimulator System Receives CE Mark Approval As MRI Conditional
Date: Aug-31-2012Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for use of its
PRECISION(TM) PLUS SPINAL CORD STIMULATOR (SCS) System in patients with the system and are
in need for magnetic resonance imaging (MRI) head-only scans. The PRECISION PLUS SCS
System is the world's first rechargeable SCS device. This approval provides physicians
with an additional diagnostic option for patients with chronic intractable pain.
"As spinal cord stimulation becomes more widespread for control of severe disabling
refractory pain, it is great to know that -- should the need arise -- head-only MRI scans
can be safely performed in patients with the PRECISION PLUS SCS System," said Dr. Simon
Thomson FFPMRCA, consultant in pain medicine and neuromodulation at Basildon and Thurrock
University Hospitals in the United Kingdom.
Chronic intractable pain is continuous pain that has lasted more than six months.
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. Chronic pain affects one in five
adults in Europe, or about 95 million people 15 to 64 years of age.
"We are pleased to announce that patients implanted with the PRECISION PLUS SCS System
will now be able to undergo MRI head scans," said Michael Onuscheck, senior vice president
and president of Europe, Middle East and Africa at Boston Scientific. "We understand the
need to provide physicians the necessary options to be able to manage their patients' care
and believe this new MRI labeling will play a role for them."
Spinal cord stimulation is a reversible therapy that manages pain through an
implantable pulse generator (IPG) and thin wires called electrodes, or "leads," that are
implanted in the spinal column. The device electrically stimulates specific nerves of the
spinal cord to mask the brain's perception of specific pain signals that move up the
spinal cord. To date, about 350,000 patients with chronic pain have been treated worldwide
with SCS therapy.
About the PRECISION(TM) PLUSSCS System
The PRECISION PLUS SCS System was approved in the United States in 2004 and received
approval in Europe and Canada in 2005. The system is the world's first rechargeable IPG.
Today, more than 60,000 patients worldwide have been treated using this system. When
compared to non-rechargeable SCS systems, rechargeable SCS systems may offer clinical
benefits by extending therapeutic longevity and therefore avoiding frequent replacement
surgeries and complications that may arise from repeated surgeries.
All cited trademarks are the property of their respective owners. Caution: The law
restricts these devices to sale by or on the order of a physician. Inactions,
contraindications, warnings, and instructions for use can be found on the product labeling
supplied with each device. Information is for use only in countries with applicable health
authority product registrations.
Courtesy: Medical News Today
Note: Any medical information available in this news section is not intended as a substitute for informed medical
advice and you should not take any action before consulting with a health care professional.