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Approval Of Medtronic’s Renal Denervation System Delayed By COVID-19

 
• By Reed Miller

Medtronic says that most of the clinical trials it is sponsoring are paused due to the pandemic, which means the completion of its PMA application for the Symplicity Spyral renal denervation system will be delayed.

A Close Up Of The Word Delayed Repeated Multiple Times On A Sign At A Station Or Airport Or Highway
• Source: shutterstock.com

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 MED is currently paused due to COVID-19, as most hospitals are postponing as many procedures as they can to focus resources on COVID-19 patients

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