St. Jude Medical Gets CE Mark for New DBS for Patients with Movement Disorders

St. Jude Medical Inc. received CE mark for the St. Jude Medical Infinity Deep Brain Stimulation (DBS) System and directional DBS lead. The St. Jude Medical Infinity DBS system, which will be available in two sizes, is the only upgradeable DBS system available to patients battling movement disorders, according to the company. The system uses Bluetooth wireless technology to communicate between the St. Jude Medical Infinity DBS platform and Apple digital devices used as patient and physician controllers. Combined, the features of the system provide an improved, more intuitive experience for patients suffering from Parkinson’s disease, tremor and dystonia, a disorder that causes involuntary muscle contractions.

Movement disorders are neurologic conditions that develop as communications breakdown throughout a patient’s central nervous system, leading to a debilitating lack of muscle control, involuntary movement, and reduced coordination. With no proven cure, treatments for movement disorders often focus on alleviating the symptoms associated with each condition to improve quality of life. Combined, Parkinson’s disease, dystonia and tremor represent the three most common movement disorders in the world.

DBS systems deliver mild electrical pulses to specific targets in the brain to stimulate the structures involved in motor control. The systems consist of a surgically implanted neurostimulator that generates the electrical pulses and thin wires called leads, which carry the pulses to the brain to influence the irregular nerve signals responsible for many of the symptoms of movement disorders.

Conventional DBS leads have a limited ability to steer current directionally, which can be challenging for physicians trying to provide effective stimulation to specific areas of the brain.

The St. Jude Medical Infinity DBS system operates in conjunction with the company’s newly approved directional DBS lead, which allows physicians to shape the therapy to a patient’s specific needs while avoiding stimulation to areas that may create side effects. St. Jude Medical designed the Infinity platform and directional lead based on physician feedback demonstrating a clear need for improved stimulation targeting, device longevity and a maintenance free, non-rechargeable battery, company officials said.

“The Infinity DBS system, including our directional lead and wireless technology, represents a major step forward in our DBS product portfolio, demonstrating St. Jude Medical’s commitment to patient-centric solutions to help alleviate the debilitating effects of movement disorders,” said Eric Fain, M.D., group president at St. Jude Medical. “Not only are we able to offer therapy solutions for a broad set of indications for movement disorders, but we’ve also designed the system to provide patients the best possible experience with their therapy while helping physicians manage their patients more efficiently and effectively.”

According to the European Brain Council, 1.2 million Europeans suffer from Parkinson’s disease. Other statistics indicate that more than 500,000 people battle some form of dystonia and an estimated 14 percent of people over 65 suffer from essential tremor, the most common form of tremor.

The St. Jude medical Infinity DBS system was designed to transform the standard of care for movement disorder patients by incorporating a number of patient-centric features. Because the Infinity system is upgradeable, St. Jude Medical said its system offers patients the ability to retain access to the latest technology and therapy options and new modes of stimulation as they are approved via software upgrades, avoiding the need to undergo repeat surgery. St. Jude Medical has also developed technology to allow patients with existing DBS systems from any manufacturer to replace their existing system to take advantage of the advancements enabled by the Infinity system.
In addition, patients will now be provided an Apple iPod Touch digital device that allows them to easily manage their therapy. Physicians will program their patient’s devices through an iPad Mini digital device. The St. Jude Medical patient and physician programmers use Bluetooth wireless technology, providing a secure, safe, and wireless experience.

“The new St. Jude Medical Infinity DBS system is enabling physicians to improve management of our patient’s symptoms so we can tailor our therapy approach and provide optimal treatment solutions unique to the patient,” said Dr. Jan Vesper, a professor of functional neurosurgery and stereotaxy at Heinrich Heine University in Dusseldorf, Germany, and president of the German Neuromodulation Society. “In addition to the benefits associated with the new Infinity platform, with the St. Jude Medical directional lead physicians will have access to a tremendous leap forward in technology that has the potential to support improved patient outcomes and potentially reduce side effects.”

Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.