ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
Device Facts
| Record ID | P840001 |
|---|---|
| Device Name | ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS |
| Applicant | Medtronic Neuromodulation |
| Product Code | LGW · Neurology |
| Decision Date | Nov 30, 1984 |
| Decision | APPR |
| Device Class | Class 3 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| P840001 · Nov 30, 1984 | ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS | Medtronic Neuromodulation | Medtronic Product Surveillance Registry (PSR); Published clinical scientific literature (systematic review of retrospective cohorts, case series, and observational studies) | The PSR and published literature were used to characterize the safety profile (adverse events, infection rates, and surgical complications) and effectiveness (pain relief, responder rates) of SCS systems in patients with diabetic peripheral neuropathy (PDN) in a real-world clinical setting. | Product Surveillance Registry; Retrospective cohort; Systematic literature review; Real-world safety; Diabetic peripheral neuropathy |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Medtronic Product Surveillance Registry (PSR); Global registry of hospitals, clinics, and clinicians; Follow-up/Duration: Median 15 months (range 0-110 months); Study Period: April 15, 2010 - October 31, 2020 | Patients treated with SCS for diabetic neuropathy (primary or secondary indication); Sample Size: 67 patients (PDN analysis set); Number of Sites: Global network | Not applicable for this study | Safety (adverse events, device events, infection rates) |
| Systematic review of published clinical literature; Systematic review of retrospective cohorts, case series, and observational studies; Follow-up/Duration: Varies by study (up to 7 years); Study Period: 1984-2021 | Patients with diabetic peripheral neuropathy (PDN) or diabetes treated with SCS; Sample Size: Multiple cohorts (e.g., Mekhail 2011: 707 patients; Falowski 2019: 6,615 patients); Number of Sites: Various | Not applicable for this study | Safety (infection, wound healing, cardiovascular events) and Effectiveness (pain relief, responder rates) |
