Medtronic announced the start of the SPYRAL AFFIRM study, which is evaluating the long-term safety, efficacy, and durability of renal denervation with Medtronic’s Symplicity system in “real-world” patients with uncontrolled hypertension.
The study was granted an investigational device exemption in June and began in early November with the enrollment of the first patient at the Piedmont Heart Institute in Atlanta. The study will include about 1,000 patients at 100 sites globally