New St. Jude Study Supports Renal Denervation - May 22, 2014
It’s been a difficult few months for Renal Denervation, a therapy that seemed to hold so much promise for patients suffering so-called treatment resistant hypertension. After all, renal denervation had shown so much promise, seemingly offering 30 point blood pressure reductions as a result of one simple operation. That was all prior to the release of the results from Medtronic’s Symplicity HTN-3 study which signally missed its outcome endpoints, despite being proven safe enough. All the other players in this developing game took a deep breath and considered their options. Covidien, recent acquirer of Maya Medical and its OneShot device, decided it had seen enough and pulled the plug.
St. Jude Medical took a deep breath and carried on. And now it’s issued a set of results from its EnligHTN III renal denervation therapy study which broadly support the therapy as delivered by its own device. Six-month data showed no serious device- or procedure-related adverse events, confirming Renal Denervation as a safe procedure. Moreover, treatment resulted in 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).
Only Sham Controlled, Blinded Renal Denervation studies will do
The only trouble with all this is that the sham-controlled, double blinded, ambulatory testing regime imposed on the Medtronic study, was not repeated in this study. The single biggest factor that people pointed at in explaining the Symplicity HTN-3 data, was missing from this new study. This begs the question why the company is and its investigator base is now sounding so chirpy about having seemingly raised the therapy, and especially their own device, Phoenix-like from the ashes of Symplicity HTN-3.
We don’t get it and we’ll be watching with interest to see if anyone else shares our views.
Meanwhile we’ll be especially interested to see whether this all washes with the FDA.
Read more here.