Approval Of Medtronic’s Renal Denervation System Delayed By COVID-19
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.
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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.
April and May were full of cardiovascular professional society conferences, yielding important new research results along with announcements of major new clinical trials. Here are a few of the highlights.
The FDA granted its breakthrough designation to SoniVie’s TIVUS and ReCor's Paradise ultrasound renal denervation systems for treating hypertension.