Glossary Term
Long-Term Follow-Up
Definition
Long-Term Follow-Up (LTFU) refers to the extended monitoring of patients after receiving a medical device, treatment, or therapy to assess long-term safety, efficacy, and outcomes. It often involves periodic clinical evaluations, imaging, laboratory tests, or questionnaires conducted over months or years post-procedure or device implantation.
Relevance to the MedTech Industry
LTFU is essential for gathering real-world evidence on the durability, performance, and patient impact of medical devices over time. It supports regulatory compliance, post-market surveillance, and continuous product improvement while building trust with healthcare providers and patients.
Additional Information & Related Terms
Related Terms
Post-Market Surveillance (PMS): Ongoing monitoring of device safety and effectiveness after market approval.
Real-World Evidence (RWE): Data collected from routine clinical practice to evaluate long-term outcomes.
Patient-Reported Outcomes (PROs): Feedback from patients on their quality of life and device impact during LTFU.
Clinical Follow-Up: Routine post-treatment evaluations, which can include both short- and long-term monitoring.
Registry Studies: Organized collections of LTFU data from patients with specific devices or treatments.