Key result
The US FDA Circulatory System Devices Panel convened to provide a road map for future clinical trials involving device-based therapies for hypertension.
The FDA Circulatory System Devices Panel convened to provide a roadmap for future clinical trials involving device-based therapies for hypertension.
T he US Food and Drug Administration CirculatorySystem Devices Panel convened οn December 5, 2018, to discuss and make recommendations regarding issues relating to the emergence of medical devices intended-to-treat and control hypertension.1 Specifically, the committee members were asked to discuss and make recommendations on the premarket clinical trial design, postapproval study design, indications and labeling for device-based hypertension treatments, patient population, clinical trial safety and effectiveness end points and margins, potential benefits and risks, and to consider issues, such as medication compliance, patient perspective, and appropriate study controls.The panel spent the day providing the agency with a road map for future clinical trials involving device-based therapies for hypertension.
No takes yet. Share an insight, caveat, or question.
Papademetriou et al. (2019) conducted an editorial in hypertension. device-based hypertension treatments was evaluated. The US FDA Circulatory System Devices Panel convened to provide a road map for future clinical trials involving device-based therapies for hypertension.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: