|St. Jude's line of DBS devices are now CE marked to treat dystonia.--Courtesy of St. Jude|
St. Jude Medical ($STJ) won CE mark approval to use its deep-brain stimulation devices to treat dystonia, making them the first implants cleared for the neurological movement disorder.
Dystonia affects about 500,000 people across Europe, St. Jude says, and the incurable disorder causes muscles to involuntarily contract and spasm, making it difficult to control movement. Now, the company's Brio, Libra and LibraXP DBS devices are approved to manage the ailment's symptoms, a milestone for the company as it grows its neurostimulation business, Implantable Electronic Systems President Eric Fain said.
"This CE mark is the first approval by a regulatory agency for the use of deep-brain stimulation therapy to manage the symptoms of both primary and secondary dystonia, broadening the treatment options for patients in Europe whose lives are impacted by this disabling disease," Fain said in a statement.
St. Jude's devices are implanted under the skin with two electrode-fitted leads running into the brain, administering pulses of energy to influence brain signals. Brio and Libra are cleared in Europe to treat Parkinson's, and the company is running trials to demonstrate the devices' effect on clinical depression but is yet to secure an FDA approval for any of the implants.
Neuromodulation is one of St. Jude's major growth targets in the coming year, the company looks to offset flat markets for implantable cardiac devices. St. Jude hauled in $423 million in neuromodulation revenue last year, a 1% increase over 2011. The company is looking to regain some ground after a 2012 temporary recall of Brio, the world's smallest DBS device, stemming from reports of bodily fluid seeping into the implant and leading to malfunction.
- read St. Jude's announcement