St Jude's five-column neurostimulation lead gains EU and Australian
approval
10 Dec 2010
St Jude Medical, Inc. (NYSE:STJ) has received the European CE
Mark and regulatory and reimbursement approval from the Australian
Therapeutic Goods Administration (TGA) for its Penta surgical lead for
neurostimulation therapy.
The company says that its five-column surgical lead is the first
of its kind, featuring the smallest electrodes on the market.
Although the Penta lead is only 10.9 mm wide, it offers the broadest
lateral electrode span of any neurostimulation paddle lead.
This
feature is made possible by a proprietary micro-texturing process
that enables greater amounts of current to be delivered via the
small electrodes. The result is a lead that can more specifically
focus current over a greater lateral area of the spinal cord, which
may provide better coverage for managing chronic pain.
“Early adoption of the Penta lead in the US has been very
promising, and we are encouraged by how well this paddle lead is
aiding physicians in controlling low back pain,” said Chris Chavez,
president of the St Jude Medical Neuromodulation Division. “We are
excited to be able to make this first-of-its-kind product available
to physicians in Europe and Australia.”
Spinal cord stimulation therapy, or neurostimulation therapy, is
used for managing chronic pain of the trunk and limbs and pain from
back surgeries that have failed. A lead is a small insulated wire
with multiple electrodes that is placed in the epidural space near
the spine. Mild electrical pulses are carried from the
neurostimulator to the lead’s electrodes to interrupt or mask the
transmission of pain signals to the brain. Electrodes on the lead
can be programmed to meet each individual patient’s needs.
“Neurostimulation therapy is often an appropriate choice for
patients who have complex pain patterns,” said Dr. Ashwini Sharan,
Associate Professor, Department of Neurosurgery and Department of
Neurology at Jefferson Medical College and Thomas Jefferson
University. “The five-column Penta lead provides the most
comprehensive spinal cord coverage available, enabling us to
specifically stimulate targeted areas in order to potentially better
control the patient’s pain.”