FDA approves St. Jude Medical’s Infinity DBS and directional leads

St. Jude Medical (NYSE:STJ) said today that the FDA approved its Infinity deep-brain stimulation device, including its DBS directional leads, to treat Parkinson’s disease and essential tremor.

The Infinity system is designed so that Apple (NSDQ:AAPL) mobile devices can be used as wireless controllers, via a Bluetooth connection; St. Jude claims the system as the only upgradable DBS platform for movement disorders.

The directional leads, the 1st to a nod from the U.S. safety watchdog, are designed to allow doctors to “steer” current to different parts of the brain, tailoring treatment to reduce side effects. Patients using the Infinity system can link it to Apple’s iPod Touch; physicians can program the device using the Apple iPad Mini, according to the company.

The 1st Infinity implantation in the U.S. was performed by Dr. Kelly Foote of the University of Florida Center for Movement Disorders & Neurorestoration at the UF Health Shands Hospital, St. Jude said.

“I’m very happy that the Infinity DBS system and its directional DBS lead are now available in the U.S. I believe that the directional lead represents an important advancement in DBS technology that has the potential to improve outcomes of DBS therapy for many patients. This new system offers the potential to diminish adverse effects of DBS by steering current away from areas of the brain that cause side effects, allowing us to better control the symptoms of Parkinson’s disease and essential tremor,” Foote said in prepared remarks.

“The St. Jude Medical Infinity DBS system and directional lead represent St. Jude Medical’s commitment to the treatment of debilitating movement disorders,” added St. Jude neuromodulation medical director Dr. Allen Burton. “The new St. Jude Medical Infinity system was designed to streamline therapy programming, allowing physicians more time to provide care to more patients. The system was also designed to provide patients with the best possible experience to manage their symptoms in a discreet manner that fits more easily into their lives.”

In June, St. Jude announced the European launch of the Infinity system and directional lead, after winning CE Mark approval in the European Union in September 2015.

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