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St. Jude Cancels EnligHTN IV U.S. Renal Denervation Trial Due to "Anticipated Recruitment Challenges"
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EnligHTN™ Renal Denervation System
EnligHTN™ Renal Denervation System
December 12, 2013 -- Mounting a multicenter, randomized, blinded, controlled clinical trial is an expensive proposition. So when device manufacturer St. Jude Medical, Inc. (NYSE:STJ) decided last week to stop its EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure, there had to be a good reason. And there was.

According to a company spokesperson, difficulties in recruitment for the trial were the main issues, not the fact there was any concern over safety or efficacy. The recruitment difficulties are no doubt tied to the fast-moving clinical trial program of St. Jude's chief competitor, Medtronic, which completed enrollment of the first U.S. pivotal renal denervation trial in May 2013 and just gained FDA approval for a second one, the SYMPLICITY HTN-4, for patients with moderate uncontrolled hypertension. Both Medtronic trials are blinded and test the renal denervation device against a sham control. Moreover, the Symplicity System was one of the first medical devices to be accepted into a new concurrent review program, wherein CMS reimbursement and FDA approval would occur simultaneously, so the device would become immediately available upon approval.

Given the advanced nature of Medtronic's program, St. Jude was clearly having trouble finding patients and physicians for testing their new device. St. Jude commented to Angioplasty.Org in an email communication:

"St. Jude Medical has decided to discontinue enrollment in the EnligHTN IV Renal Denervation Study, a U.S. clinical trial designed to evaluate the effectiveness of the EnligHTN™ Multi-Electrode Renal Denervation System in treating patients with drug-resistant high blood pressure. 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.

"St. Jude Medical is highly committed to the research and development of renal denervation as we recognize the significant potential of this therapy to dramatically improve the lives of millions of patients with severe high blood pressure. We are investing in numerous studies to build a significant body of clinical evidence, including the landmark EnligHTNment trial that will evaluate whether renal denervation can reduce the risk of major cardiovascular events such as heart attack, stroke, heart failure requiring hospitalization and cardiovascular death."

Reported by Burt Cohen, December 12, 2013