Preliminary results from the St. Jude Medical EnligHTN III study have been presented during a hot line late-breaking clinical trial session at EuroPCR 2014. The company’s second-generation EnligHTN™ renal denervation system reportedly provided safe and effective therapy for patients with drug-resistant, uncontrolled hypertension six months post-procedure. Is this enough to get the therapy back on the rails after the disastrously unspectacular Symplicity HTN-3 study data issued back in January.
The EnligHTN III study is an international, non-randomized clinical trial that followed device performance and assessed outcomes through six months of follow-up for 39 eligible patients. Preliminary results confirmed safe, rapid and sustained reduction in blood pressure measurements for patients with drug-resistant hypertension.
Six-month EnligHTN III data showed an average systolic blood pressure reduction of 25 mmHg points, with 81 percent of patients responding to the therapy (defined as a blood pressure reduction of at least 10 mmHg when measured during an office visit).
No serious device- or procedure-related adverse events reported.
So all good then? The renal denervation show’s back on the road after Medtronic’s study came up short of delivering the goods when the Symplicity HTN-3 study was reported?
Well, not quite. The problem with this study, in contrast to Medtronic’s effort that was praised for its scientific basis, was that it was neither blinded, randomised or sham-controlled. That leaves it open to the same criticism that was levelled at earlier studies and which was used to explain the lack of impact of the therapy in the Symplicity study. One thing that’s for sure is that companies like Covidien don’t drop therapies lightly when they’ve just invested in them; they were obviously convinced enough by Medtronic’s study to drop their own equivalent device and it’s hard to see the St. Jude study making them regret that decision. Nonetheless, the principle investigator in the St. Jude study is sounding bullish.
“This six-month data from EnligHTN III provides further evidence of the benefits associated with this next-generation renal denervation system,” said Prof. Stephen Worthley of St. Andrew’s Hospital in Adelaide, Australia, a principal investigator of the EnligHTN III study. “This study demonstrates that the next-generation EnligHTN renal denervation system delivers safe and effective treatment that is aligned with the outcomes of the first generation system, and ultimately saves time in the procedure room.”
“St. Jude Medical is encouraged by the positive clinical results we’re seeing from our renal denervation studies,” said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical. “We have a long history of advancements in ablation technologies and have used our internal product development capabilities to optimize our multi-electrode renal denervation technology. We believe this therapy has the potential to dramatically improve the lives of millions of patients with severe high blood pressure and will continue to invest in renal denervation as a potential long-term growth driver.”
Source: St. Jude Medical, Inc., Business Wire