Medtronic PLC was on track to complete the pivotal trials of its Symplicity Spyral renal denervation catheter system and submit it for a premarket approval with the US Food and Drug Administration in mid-2020, but that timeline has been delayed indefinitely by the COVID-19 pandemic.
Medtronic’s PMA for Symplicity Spyral will be supported by three-month results from both the SPYRAL HTN-ON MED and SPYRAL HTN-OFF MED trials. However, ongoing enrollment in SPYRAL HTN-ON...