St. Jude Medical Wins FDA Nod for Spinal Cord Stimulator
St. Jude Medical has won FDA 510(k) clearance for its Invisible Trial system, a spinal cord stimulator that incorporates Apple products and Bluetooth wireless technology.
Before receiving a permanently implanted SCS device, patients undergo a trial period to evaluate whether the therapy is right for them. However, often times these systems have complex controllers and bulky programming cables, the St. Paul, Minn., devicemaker said Thursday.
St. Jude Medical claims that it has removed these barriers by incorporating wireless technology and a more user-friendly iPod touch as a controller. Medical professionals can then use an iPad to program and evaluate patient therapy.
Additionally, the Invisible Trial features a small external pulse generator to power the system, which allows for a reduced device profile, the company says. — Jason Scott