Boston Scientific receives EU clearance for new lead for electrical
7 November 2006
Natick, Mass., USA. Boston Scientific Corporation
(NYSE:BSX) today announced that it has received the European CE Mark for its
new Artisan 2x8 surgical lead for use with the Precision Spinal Cord
Stimulation (SCS) System. This surgical or "paddle" lead potentially expands
the application of the company's neurostimulation technology to an
additional 20% of people with chronic pain of the limbs, back or trunk who
may require the new lead.
In Europe, one in five people suffers from
moderate to severe chronic pain, and one in three is unable or less able to
maintain an independent lifestyle due to their pain. Between one-half and
two-thirds of people with chronic pain are less able or unable to exercise,
enjoy normal sleep, perform household chores, attend social activities,
drive a car or walk.
"The Artisan lead addresses the needs of those
patients who require the stability of a surgical lead to reap the benefits
of the precise stimulation technology," said James Akinwunmi, consultant
Neurosurgeon at Princess Royal Hospital in West Sussex, UK, who has a
special interest in Pain Management. "The combination of the Artisan lead
with the Precision System makes neurostimulation accessible to more patients
with chronic pain."
The Artisan 2x8 Surgical Lead features 16 tightly
spaced contacts in a two-column array that are connected to the Precision
implantable pulse generator. This enables each of the 16 Artisan lead
contacts to be independently powered and controlled.
The Precision SCS
System is a small implantable neuromodulation device that can be easily
programmed to fit each patient's needs. It provides pain relief by
delivering electric signals that mask the pain by inducing a tingling
sensation called paresthesia. Patients can control their pain in a targeted
fashion using a convenient remote control that activates the device.
innovative Artisan Surgical Lead enables physicians to use the Precision SCS
System in an additional estimated 20 percent of chronic pain sufferers who
require the features of a paddle lead to benefit from our novel technology,"
said Ed Northup, President of Boston Scientific's Pain Management business.
"Neurostimulation offers a safe alternative for sufferers of chronic pain,
particularly as it avoids the side effects of painkillers."