Medtronic Receives FDA Pre-Market Approval for New Neurostimulation Device

Today, Medtronic announced that it has received pre-market approval (PMA) for a new neurostimulation device called "Specify," which features 16 electrodes in 3 columns on a curved paddle.  The curved paddle is supposed to conform to the anatomy of the epidural space more effectively. This is the first tripolar stimulator that has received pre-market approval from the FDA.

Spinal cord stimulators are often used for those who have chronic back pain or failed back surgeries, and can be very effective in decreasing pain.

"The Specify 5-6-5 surgical lead from Medtronic optimizes the tripolar design," according to neurosurgeon Dr. Michael Turner of Indianapolis Neurosurgical Group in Indiana. "The curved shape of the paddle allows for an improved anatomical fit within the epidural space, which itself is curved to conform to the cylindrical shape of the spinal cord, and should therefore minimize the potential for lateral lead migration. Compared to a flat paddle, this anatomically conforming design also promotes more consistent contact of the three columns of electrodes with the dura, the strong fibrous membrane that surrounds and protects the spinal cord."

Medtronic is the leader in neurostimulation and medication pumps.  They estimate that over 75 million people in the United States alone suffer with chronic pain.  To date, over 200,000 people have been treated worldwide with Medtronic's neurostimulation technology.