Long-term Surveillance of the MedStream Programmable Infusion System

Study Overview
=================
Brief Summary
-----------------
This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity. A secondary objective, to assess long-term effectiveness, based on the observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm Scores over the 36-month follow-up period will also be described.

Official Title
-----------------
Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity

Conditions
-----------------
Spasticity

Intervention / Treatment
-----------------
* Device: MedStream Programmable Infusion System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is a viable candidate for de novo or continued (pump replacement) therapy for the treatment of severe spasticity with intrathecal Baclofen delivered by an implantable programmable pump. The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study in accordance with 21 Code of Federal Regulations (CFR) Part 50. The subject is willing to comply with the protocol-specified follow-up visit requirements for a period of 36 months after implant. The subject has an anticipated life expectancy of 24 months or greater. The subject must be 18 years of age or older at time of MedStream implant procedure. The subject is of sufficient body size to accommodate pump placement, in the opinion of the Investigator. The subject will receive a de novo or replacement implant of the MedStream 20 mL or 40 mL pump, MedStream approved catheter(s) and MedStream accessories. The Investigator intends to use Baclofen in the pump for treatment of severe spasticity The subject is capable of self-reporting spasm frequency. Exclusion Criteria: Concurrent enrollment in an investigational device or drug study that has not completed the required follow-up period. Subject has had an infection and/or inflammation at or near the pump and/or catheter implantation site(s) within 30 days preceding enrollment. Evidence of a fever or infection within 10 days prior to the surgical implant procedure that, in the opinion of the Investigator might impact a successful pump implant. The subject has known hypersensitivity/allergies or contraindication to Baclofen or the materials in the infusion pump or catheter(s). The subject has a co-morbid condition that could limit his/her ability to participate in the study or to comply with the follow-up requirements or, which might impact the scientific integrity of the study. The subject has a rapid degenerative neurological disease such as lateral sclerosis, amyotrophic lateral sclerosis (ALS), rapidly progressive Multiple Sclerosis, inherited or rapidly progressive leukodystrophies, Moyamoya disease, cerebral autosomal dominant arteriopathy with subcortical infarcts and leucoencephalopathy (CADASIL), thrombophilias, rapidly progressive autoimmune disorders, or any disorder where progression of the underlying spinal cord or a central nervous system (CNS) disease is expected to progress significantly over the next 3 years Subject is a prisoner. Subject was previously enrolled in this study. Subject is pregnant or breastfeeding. (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MedStream System Implants<br>All subjects presenting for a de novo programmable pump implant or replacement of an implantable, programmable infusion pump for the treatment of severe spasticity with intrathecal Baclofen. | Device: MedStream Programmable Infusion System<br>* Intrathecal Infusion of Baclofen in the Treatment of Spasticity<br>* Other names: MedStream Infusion system;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the incidence of MedStream system-related Adverse Events (AE) | The primary endpoint is the incidence of MedStream system-related AEs (MedStream pump and catheters) based on Clinical Events Committee determination of relationship, that occur from the start of the MedStream implant procedure (incision) until completion of the 24 month follow-up visit | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MedStream system-related AEs occurring from 24 to 36 months |  | 36 Months | 
| Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study. | Device-related AEs occurring in subjects with both MedStream and non-MedStream devices used or implanted during the course of the study. Device refers to the pump and intrathecal catheters | 24 Months | 
| Procedure-related AEs | Procedure-related AEs including, but not limited to the following study procedures: MedStream system implant, pump refill and bolus, and reprogramming. If non-MedStream devices or components are utilized in these procedures, this will be described. | 24 Months | 
| Drug-related AEs associated with intrathecal Baclofen |  | 24 Months | 
| Drug-related AEs associated with other intrathecally-administered medications |  | 24 Months | 
| Disease-related AEs associated with pre-existing conditions | Disease-related AEs associated with pre-existing conditions that demonstrate a significant worsening of the disease or an increase in the frequency of episodes since baseline, as determined by the investigator. | 24 Months | 
| Serious Adverse Events (SAEs) |  | 36 Months | 
| Unanticipated Adverse Device Effects (UADEs) |  | 24 Months | 
| The secondary effectiveness endpoints will be long-term effectiveness of MedStream System | Long-term effectiveness as demonstrated by scores on the Ashworth Scale (lower extremity) and the frequency and severity components of the Penn Spasm Frequency Scale (PSFS) measured pre-implant, post-implant and at each of the protocol-specified study visits. | 24 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spasticity, muscle spasticity, muscle rigidity, motor neuron disease, hyperreflexia