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Medtronic Pushes Completion Of Pivotal Renal Denervation Trial To Late 2022

 
• By Reed Miller

The company announced that results from the pivotal SPYRAL HTN-ON MED trial of its Symplicity renal denervation system will not be available until the trial completes enrollment next year. The company previously expected to be able to present favorable interim results from the trial in November.

Medtronic Symplicity Renal Denervation System • Source: Medtronic PLC

The long-awaited US launch of Medtronic’s Symplicity renal denervation system for treating drug-resistant hypertension will be delayed another year, the company explained in a 15 October filing with the Securities and Exchange Commission.

Medtronic now estimates that it will be able to file a premarket approval application for Symplicity in the second half of calendar year 2022. This represents a delay of about...

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

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