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St Jude Medical has received CE Mark approval for its new Infinity Deep Brain Stimulation (DBS) system and directional DBS lead.

The Infinity DBS system, which will be available in two sizes, is claimed to be the only upgradeable DBS system available to patients combating movement disorders.

By using Bluetooth wireless technology, the system establishes communication between the St Jude Medical Infinity DBS platform and Apple digital devices, which are used as patient and physician controllers.

"The Infinity DBS system, including our directional lead and wireless technology, represents a major step forward in our DBS product portfolio."

The system includes features that will help to provide an improved service 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 (CNS), leading to a debilitating lack of muscle control, involuntary movement and reduced co-ordination.

St Jude Medical group president Dr Eric Fain 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.

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"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."

DBS systems include a surgically implanted neurostimulator, which generates electrical pulses and thin wires called leads that carry the pulses to the brain to determine irregular nerve signals responsible for many symptoms of movement disorders.

The system is said to operate in conjunction with the company’s newly approved directional DBS lead, which allows physicians to provide therapy according to the patient’s specific needs and avoids stimulation to areas that may create side effects.

It was designed to transform the standard of care for movement disorder patients by incorporating a number of patient-centric features.

German Neuromodulation Society president Dr Jan Vesper said: "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.

"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."

Earlier this month, the company received CE Mark approval for the 27mm and 29mm Portico transcatheter aortic valve replacement (TAVR) system.

Previously, the firm secured approval for the 23mm and 25mm Portico valves, providing physicians with an expanded range of fully repositionable and retrievable TAVR valve sizes.


Image: St Jude’s Infinity DBS system is the only upgradeable DBS system available for patients with movement disorders. Photo: courtesy of St Jude Medical.