Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for its StealthStation software, which is designed to help plan the placement of the leads used for deep-brain stimulation therapy.
Fridley, Minn.-based Medtronic said StealthStation is designed to work with its O-arm imaging system to integrate pre-operative planning and intraoperative imaging during DBS device implantations.
“The new StealthStation software works seamlessly with O-arm to give me a single solution for pre-operative planning and real-time 3D imaging of the brain in the OR, and that streamlines my workflow for DBS lead placement,” Dr. Jonathan Carlson, of Washington’s Providence Spokane Neuroscience Institute, said in prepared remarks. “Now I have the essential information I need in one place, giving me – and my patients – even more confidence in the procedure.”
Medtronic said the StealthStation software has been used in more than 2.25 million procedures over the last 25 years.
“We alleviate pain, restore health and extend life by providing informed and integrated neurosurgical procedures to our customers and their patients,” added neurosurgery GM Scott Hutton. “And as we transform the way the world treats patients with neurologic disorders, we’ll utilize the breadth of our broad Brain Therapies portfolio in new and different ways to bring fully-integrated solutions like this to our customers.”
Earlier this year, Medtronic won expanded FDA approval for its DBS therapy for patients with Parkinson’s disease, which 1st won approval from the safety watchdog in 2002.