Medtronic (NYSE:MDT) will continue the Spyral clinical study of its Symplicity renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early.
Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular Research Foundation’s TCT Conference in early November, pending an interim analysis in October.
Significantly positive results would have advanced Medtronic’s efforts for FDA approval, but the independent data safety monitoring board conducting that analysis — meant to end trial enrollment if results are significantly better or worse than expected — recommended that Medtronic continue enrolling patients.