Pivotal Medtronic Trial For "Breakthrough" Blood Stress Device Goes Down The Tubes

The hypertension local community woke up this morning to a huge dose of reality with an announcement by Medtronic that the a lot-anticipated SYMPLICITY HTN-three trial of its novel renal denervation device had failed to meet its main efficacy endpoint. Renal denervation has been broadly touted as a breakthrough merchandise that could drastically reduce blood strain by as much as 30 mm Hg, permitting physicians to remedy the most significant type of higher blood pressure, resistant hypertension.

“SYMPLICITY HTN-three met its major security endpoint connected to the incidence of key adverse occasions one month following randomization and renal artery stenosis to six months,” stated Deepak Bhatt, the co-principal investigator of the trial, in the Medtronic press release. “Importantly, nonetheless, the trial did not meet its primary efficacy endpoint.” To show efficacy in the trial blood pressure in the treatment method arm would have essential to be 10 mm Hg decrease than in the handle arm.

Medtronic mentioned that simply because no security considerations emerged in the trial, “no particular action is currently indicated for sufferers who have had the renal denervation procedure with the Symplicity method.” The organization mentioned it will assemble a panel of independent advisors “to make suggestions about the potential of the global hypertension clinical trial system.”  Until then Medtronic mentioned it would suspend enrollment in ongoing trials, including the SYMPLICITY HTN-4 trial studying renal denervation in individuals with much less serious varieties of hypertension. Symplicity will still be accessible in Europe and other markets where it has been accredited and the firm will carry on its international submit-market surveillance registry as nicely as studies that are evaluating other non-hypertension indications for the gadget.

Wells Fargo analyst Larry Biegelsen stated that the news means that that Medtronic is unlikely to achieve US approval for the gadget with no very first operating yet another trial.

Until finally just lately the forecast for renal denervation had been very optimistic. In December 2012 the American Heart Association listed renal denervation as one of its top advances of 2012 and there had been glowing reports in health-related journals and continuing healthcare education applications as nicely as the well-known press. A single newspaper quoted a former president of the American Heart Association: “It makes one particular dizzy to feel about the following set of advantages that stick to.”

Much more sensible expectations started to seem in 2013. As I reported last summertime, a paper published in Heart showed that the big reductions in blood stress seen in earlier clinical trials of renal denervation were most likely a solution of serious flaws in the style of these trials. Right up until SYMPLICITY HTN-3 the renal denervation trials had been largely uncontrolled, unblinded, and had utilized workplace-primarily based blood stress measurements rather than the far a lot more trustworthy and consistent ambulatory blood pressure monitoring. The senior writer of the Heart paper, Darrel Francis,  predicted that ”people are going to be severely disappointed” by the benefits of SYMPLICITY HTN-3.

In December St. Jude confirmed that it had halted enrollment in its EnligHTN IV trial, which was the pivotal trial for its very own renal denervation gadget.  Renal denervation items are at present offered in Europe and elsewhere from Medtronic, St. Jude Health-related, Boston Scientific, Covidien, Recor, and Terumo.

Pivotal Medtronic Trial For "Breakthrough" Blood Stress Device Goes Down The Tubes