The FDA is hosting a panel meeting on leadless pacemaker devices, looking to St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) to join the discussion and make recommendations on acceptable guidelines on the devices.
The panel committee will seek recommendations on clinical trial and post approval study design and physician training, and will be asked to make recommendations on generally acceptable acute and chronic profiles of key adverse event rates and indications for use with leadless pacers.
