Device Dossier

TH90P Handset with Communicator - Multi-purpose electrical stimulation system programmer

Device Dossier for TH90P Handset with Communicator - Multi-purpose electrical stimulation system programmer (Multi-purpose electrical stimulation system…

Intended purpose

Sacral neuromodulation therapy provided by the InterStim system is indicated for the management of the following chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract: overactive bladder, fecal incontinence, and nonobstructive urinary retention. The Medtronic TH90P Kit contains the TM90 Communicator and HH90 Handset which is programmed with the Micro Clinician and Micro My Therapy software. The Medtronic Model TM90 Communicator is intended for patient or clinician use, to connect the app installed on the Model HH90 handset to the implantable medical device. The app on the handset interacts with the implanted medical device through the communicator.

Functional description

The Micro Clinician App allows the clinician to individualize therapy by choosing from a wide range of noninvasive programmable parameters and stimulation modes. The Micro Clinician App interrogates and programs neurostimulators using telemetry and displays its current parameters. The Micro My Therapy App allows patients to turn the neurostimulator ON and OFF and to adjust the amplitude within pre-set clinician prescribed limits.

TGA Public Summary