Intrathecal Baclofen for Severe Spasticity: Longitudinal Data From the Product Surveillance Registry.

ABSTRACT:

Objective

To assist in the assessment of intrathecal baclofen (ITB) therapy risks and benefits by providing surgical intervention rate, safety, and elective device replacement rate data.

Materials and methods

An ongoing prospective, long-term, multicenter Product Surveillance Registry (PSR) (NCT01524276) enrolled consented patients implanted with the SynchroMed II infusion system. Pump and catheter performance data were collected, with patients followed prospectively for events related to the device, procedure, and therapy. Investigators provided event descriptions, patient symptoms, and patient outcomes.

Results

We analyzed registry data from 1743 patients (77% adult, 46.8% female) treated with ITB for severe spasticity at 53 registry sites between August 2003 and Oc

SUBMITTER: Schiess MC 

PROVIDER: S-EPMC7687224 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature