Medtronic’s Symplicity Spyral renal denervation system [Image from Medtronic]
Medtronic: Symplicity Spyral renal denervation system
Medtronic re-introduced its Symplicity Spyral renal denervation system in March 2020, six years after a clinical trial produced disappointing results.
First announced in 2010, the Symplicity device is designed to treat high blood pressure through ablation of the renal arteries. After its HTN3 trial failed to meet its efficacy endpoint, Fridley, Minn.-based Medtronic suspended enrollment in other Symplicity trials and took a $200 million write-down on its renal denervation assets.
Renal denervation, however, is making a comeback. Medtronic said in February this year that it started enrollment in a pilot study of the Symplicity system in a targeted procedural approach with fewer radio-frequency ablations.
Results from a pivotal trial of the Symplicity Spyral were presented as a late-breaking clinical trial at American College of Cardiology Scientific Session on March 29. Renal denervation using the system was shown to be safe, effective and superior to sham in reducing blood pressure at three months in patients without anti-hypertensive medications.
“It’s hard to speculate on when we might see a U.S. approval because that’s dependent on discussions and determinations by the FDA,” Medtronic spokeswoman Riley Schweiger told MDO. “Our conversations have gone well, and they have reacted positively to our approach to collecting a comprehensive set of evidence.”
