FDA label expansion for Johnson & Johnson’s ThermoCool SmartTouch Catheter marks milestone in use of real-world evidence in regulatory decision making for medical devices
FDA approval is based on clinical evidence from a single comparative effectiveness study exclusively using real-world evidence derived from electronic health record data.
As documented in their recent roundup, the FDA has granted a label expansion for ThermoCool SmartTouch Catheter for cardiac ablation to include the treatment of persistent atrial fibrillation. Uniquely, the approval is based on real-world evidence (RWE) from a retrospective, comparative effectiveness cohort study using electronic health records (EHRs) from two US hospital systems. This marks the first time the FDA has based their decision for a medical device on RWE from routine clinical practice. The approval is also the first Test-Case study conducted through the National Evaluation System for health Technology (NEST) system to result in an approved label extension.
NEST was established in 2016 by the Medical Device Innovation Consortium (MDIC) through funding from the FDA. The purpose of NEST is to transform the way medical device technologies are tested, approved, and monitored through advances in RWE methodologies and increasing the quality and efficiency on RWE generation to inform regulatory and clinical decision-making for medical devices. Test-Case projects explore the feasibility of using real-world data (RWD) sources across the medical device ecosystem and were solicited by a variety of medical device organizations, including manufacturers. The learnings and findings of 21 Test-Cases across various medical device scenarios are currently available via the NEST website.
This milestone approval is based on the Test-Case ‘The Feasibility of Using Real-World Data in the Evaluation of Cardiac Ablation Catheters’ proposed by Biosense Webster, Inc., part of Johnson & Johnson. Working with Mercy Health, Mayo Clinic and Yale-New Haven Hospital, the feasibility of the study was assessed through examination of the reliability and relevance of the data quality and whether sufficient representativeness of the sample population for a robust and rigorous study. Prior label extensions have relied on evidence from case report forms. As noted in the published study results, the study is ‘the first retrospective cohort study using data from EHRs and health system supply chain data as the sole sources of clinical evidence for a medical device indication extension application’.
Commenting on LinkedIn, Paul Coplan, study author and VP and Global Head of Medical Device Epidemiology, Johnson & Johnson explained:
“Using RWE to expand the product label to include new indications has been a holy grail for many of us working in the field of RWE…..This is an important milestone for patients and regulatory science, opening a pathway for other evidence-based innovations to benefit patients and improve health.”