FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.
Experts on US FDA's Circulatory System Devices Panel say they are encouraged that device interventions currently in development will help address the hypertension "epidemic" in the US that is not currently well-managed by medication and lifestyle interventions alone.
At the panel's Dec. 5 meeting in Gaithersburg, Md., FDA gathered suggestions to help sponsors and the agency design...