Could Medtronic Dismiss Its Own Study in Quest to Revitalise Renal Denervation? - March 10, 2014
The end of March will see the international interventional cardiology community listening intently at the American College of Cardiology meeting in Washington. Symplicity HTN-3 investigators have promised to deliver findings that could kill off an entire therapy area or alternatively reinvigorate it with explanations of what went wrong in the study. In the meantime one writer is referring to an “eerie quiet across the field” of renal denervation.
John Brosky, Europe editor of Medical Device Daily puts it nicely when he says Renal Denervation was a bandwagon in Europe. It surely was, and we’ve even used that word ourselves in the past. Now though, the bandwagon has lost at least one wheel following the widely reported news that Medtronic’s pivotal U.S. trial failed to meet the primary endpoint for efficacy. The fallout included Covidien putting a stop to all investment in the technology, despite having invested $60 million buying Maya Medical as recently as last year.
You can read John Brosky’s piece here: it’s a pretty thorough going over of the therapy and the industry, in the context of recent events. What’s interesting though is the speculation about how things will pan out.
Renal Denervation on trial
Jim Reekers, MD, Professor of interventional radiology at the University of Amsterdam and former president of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE; Vienna) told radiologists at a recent ECR meeting that Medtronic may attempt to destroy their own study, stating; “Yes. That is essentially it. Medtronic has been responsible in bringing out the press release. And it is important to remember that even Medtronic does not know the real causes of missing the efficacy endpoint, has no idea of what the data are because it is truly an independent trial.”
One other speaker, Marc Sapoval, MD, Professor of Clinical Radiology and Chairman of Cardio-Vascular Radiology at the Hôpital Européen Georges Pompidou (Paris) has his own ideas. Incidentally Sapoval is also the lead investigator for the DENER-HTN Renal Denervation in Hypertension study of 120 patients over 36 months that will be published in June, 2014. The trial included a randomized arm for bilateral renal denervation using Medtronic’s Symplicity catheter.
“I have no special information [about HTN-3] but I believe there will be negative results from the way it will be analyzed,” he replied. “I suspect in the sham control arm the patients probably took their drugs and their level of blood pressure decreased more than was expected. I also believe that technology matters, so perhaps some other devices will be more effective. As I showed in my presentation the depths of the renal nerves require a penetration depth of up to six millimeters, so that if ablation was only two millimeters, it may not have been effective enough.”
So there we have it. This is all interesting stuff, but mostly pure speculation in advance of the flurry of activity that will start at the end of March.
Next Article: New St. Jude Study Supports Renal Denervation