Dive Brief:
- Abbott said it received FDA approval for a software upgrade to its Infinity deep brain stimulation (DBS) system for Parkinson's disease and essential tremor that allows patients implanted with the device to have a full-body MRI scan. MRI-compatibility removes a barrier to receiving DBS therapy for some patients because of the potential need for an MRI in the future, Abbott said.
- The approval allows existing implanted Infinity DBS systems to be upgraded via secure Bluetooth wireless technology without the need for surgery, the company said. Additional new system upgrades are aimed at simplifying the programming process for physicians.
- Abbott said its Infinity device is the only DBS system operating on an iOS software platform with Bluetooth wireless technology. Clinicians can program the system with an iPad Mini device using Abbott software, and patients can manage their symptoms with an iPod Touch controller.
Dive Insight:
Deep brain stimulation has been used to treat chronic pain for several decades, and more recently was approved for treating essential tremor and involuntary movements associated with Parkinson's disease, dystonia and multiple sclerosis.
Abbott acquired its neuromodulation business, including its DBS systems, through its 2017 purchase of St. Jude Medical. The Infinity DBS system won FDA approval in October 2016 to treat Parkinson's disease and essential tremor.
For deep brain stimulation therapy, leads are implanted in an area of the brain that controls movement and are connected to a battery-powered neurostimulator — similar in function and appearance to a cardiac pacemaker — that is implanted in the chest. The leads direct mild stimulation toward targeted areas of the brain to limit Parkinson’s symptoms such as tremor. Patients can control the level of stimulation via an iPod Touch with Bluetooth connectivity.
An Abbott spokeswoman said several thousand patients to date have received an Infinity DBS implant in nearly 30 countries. In the past year, several new hospitals around the globe began offering the technology to patients, she said.
Key competitor Medtronic's DBS system was approved in 2002 to treat advanced Parkinson's disease and gained approval in 2015 for Parkinson's patients with recent onset of motor complications. The company says more than 150,000 of its devices have been implanted for Parkinson's symptoms and other conditions.
Some of Medtronic's DBS systems are also MRI-compatible. The company estimates seven out of 10 DBS-eligible patients with movement disorders may need an MRI within 10 years of receiving their device.
The latest entrant to the U.S. DBS market, Boston Scientific, received FDA approval in December for its Vercise system to treat Parkinson's disease.
