FDA clears Multi-Lead Trialing Cable for SCS therapy

Medtronic Inc. (NYSE: MDT), the leader in spinal cord stimulation for more than 25 years, today announced U.S. Food and Drug Administration (FDA) clearance and the global launch of the Multi-Lead Trialing Cable for use in the patient screening test for Medtronic spinal cord stimulation (SCS) therapy. Introduced this month in the United States, Europe and Canada, the streamlined trialing system allows physicians to test a wide array of stimulation settings prior to implanting a neurostimulator to provide long-term pain management.

“With the new Multi-Lead Trialing Cable, Medtronic has now amplified the benefit that will allow physicians to facilitate a more accurate and comfortable test experience for patients.”

The Multi-Lead Trialing Cable offers patients a comfortable trial experience and multiple secure lead configurations with up to 16 test electrodes and only one small cable and no extensions. By contrast, other trialing systems on the market require the patient to be connected to multiple cables or extensions if the physician prefers to trial more than one lead.

"The new Medtronic trialing system is designed to give physicians flexibility in the spinal cord stimulation trialing procedure, allowing us to more closely simulate the potential relief a patient may experience with long-term therapy," said John Huffman, M.D., medical director, Pain Management and Anesthesiology, Holy Cross Hospital in Silver Spring, Md. "It represents an important advancement in the ongoing development of spinal cord stimulation and will be very useful in the overall course of treatment for patients who are likely to be good candidates for the therapy."

The first step in the SCS treatment process typically involves a test stimulation or trial period in which the patient receives an external test stimulator in a simple outpatient procedure. During the three- to 10-day trial period, patients receive stimulation through thin wires (leads) connected to an external trialing cable.

If the trial procedure is successful, a spinal cord stimulator about the size of a small pocket watch is implanted under the skin in a minimally invasive outpatient procedure. The neurostimulator delivers controlled, electrical pulses through leads to the epidural space to block pain signals from reaching the brain. The physician adjusts the stimulation settings to optimize the therapy and pain control for each patient.

"One of many great benefits of spinal cord stimulation for the treatment of chronic, intractable pain is the ability for patients to test the therapy before receiving an implantable system," said Tom Tefft, senior vice president and president of the Neuromodulation business at Medtronic. "With the new Multi-Lead Trialing Cable, Medtronic has now amplified the benefit that will allow physicians to facilitate a more accurate and comfortable test experience for patients."

To date, more than 250,000 people worldwide have received Medtronic SCS treatment for chronic, intractable pain in the trunk and/or limbs. Patient information on current Medtronic neurostimulation pain therapies is available at www.TameThePain.com or 1-888-430-PAIN (7426). Clinician information about the Multi-Lead Trialing Cable is available at http://professional.medtronic.com/mltc.

Medtronic's Leadership in Neuromodulation
Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company's Neuromodulation business offers innovative therapies for chronic pain, movement disorders, obsessive-compulsive disorder, spasticity, overactive bladder, enlarged prostate and gastroparesis. To date more than 500,000 people worldwide have received Medtronic Neuromodulation therapies.

Based on expertise in cardiac electrical stimulation, Medtronic began its first exploratory projects in neuromodulation in the 1960s. Since then Medtronic has pioneered and introduced multiple first-of-their-kind neuromodulation therapies:

• The first and only fully programmable implantable drug pump, first approved by the U.S. Food and Drug Administration (FDA) in 1982 and since then approved for various uses, including severe spasticity (Medtronic ITB Therapy^SM), chronic pain and cancer pain (SynchroMed® family of pumps);
• The first spinal cord stimulator for the treatment of chronic pain, which was granted FDA approval in 1984;
• The first deep brain stimulation (DBS) system (Medtronic DBS Therapy), first approved in the United States in 1997 for essential tremor; it is now available for advanced Parkinson's disease, dystonia (under an FDA Humanitarian Device Exemption/HDE granted in 2002) and obsessive-compulsive disorder (under an FDA HDE granted in 2009); Medtronic remains the only company with a commercially available DBS system in the United States;
• The first and only sacral nerve stimulation therapy (InterStim® Therapy) for overactive bladder and urinary retention, first approved by the FDA in 1997; and
• The first and only gastric stimulator (Enterra® Therapy) to treat symptoms of gastroparesis, available under an FDA HDE since 2000.