Last week, the FDA panel narrowly voted against endorsing Medtronic's blood pressure treatment device, citing a risk-benefit imbalance. According to the Reuters article, the agency favored ReCor's competing device for treating high blood pressure unresponsive to medication. The panel was divided on Medtronic's device benefits, leading to a tied vote broken by the panel chair, resulting in disapproval. While safety was agreed upon, six out of thirteen members voted against effectiveness. The non-binding panel recommendations typically sway FDA decisions. Medtronic valued the discussion and agreed to collaborate on new options.
FDA Panel Rejects Medtronic Blood Pressure Device
Differing verdicts on Medtronic and ReCor blood pressure devices led to varying approvals in the U.S. and Europe.
Aug 29, 2023