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.
“The decision was based on anticipated recruitment challenges and is not a consequence of a safety or efficacy issue with the device or study. A U.S. clinical trial for Enlightn remains a very high priority for St. Jude Medical and we will be working with FDA to develop a new protocol that will address anticipated enrollment challenges,” Denise Perkins-Landry wrote in the email. “At the time the Enlightn IV study was established, little was known about the timeline for approval of a renal denervation system in the U.S. We now expect a competitive device will be approved in the U.S. before we will be able to complete enrollment in our Enlightn IV study. We do not believe it is reasonable to expect physicians and patients to enroll in a trial that randomizes against a sham procedure when an approved device is available and when there is a low likelihood that the trial can be completed. It is important to note that stopping enrollment is not a consequence of a safety or efficacy issue with the device or the study. The company will work with the FDA to develop a new protocol that would simplify study enrollment, shorten overall study duration and avoid exposing patients to a sham procedure.”
The Enlightn I through III trials took place in Australia, Greece, Europe and New Zealand. St. Jude presented positive 1-year results from the Enlightn I trial at the annual EuroPCR meeting in Paris last May, the same month the St. Paul, Minn.-based medtech maker began enrollment in the Enlightn III trial.
Dr. William White of the University of Connecticut Medical Center, an Enlightn IV steering committee co-chair, said some study centers were already enrolling patients when the decision was made last week to pull the plug, according to heartwire.
“In the grander scheme of things, I can tell you that the decision was not made because of any problem with the catheter or any safety issues,” White told the website. “The clinical scientist in me would have preferred that we go ahead as planned. I think we would have gained a great deal of knowledge.”