St. Jude Medical halts Enlightn IV trial
St. Jude Medical halts the Enlightn IV trial of its renal denervation technology just a few months after getting the green light to begin enrollment.
The trial of St. Jude's multi-electrode Enlightn device was slated to enroll about 590 patients between the ages of 18 and 80 with high blood pressure that isn't well-managed with drugs.
But concerns that a competing Medtronic (NYSE:MDT) device, the Symplicity, could reach the U.S. market led St. Jude to spike the Enlightn IV trial, which it launched in May. Having another technology on the market would make it tough to interest patients in the trial, which might see them enrolled in the sham arm of the study, a company spokeswoman told MassDevice.com in an email.