I promise I care about non-renal denervation medical devices. Really, I do. But this area is just so dynamic that it keeps drawing my attention. So be it.
I was there, sitting in the main presentation hall at the Walter E Washington Convention Center, when the results of SYMPLICITY HTN-3 were presented. For the rest of 2014, it seemed like no developments in the renal denervation space were happening: funding had dried up, clinical trials were put on hold, and manufacturers stopped mentioning the products in their earnings calls.
All that has changed yet again. Both Medtronic and Boston Scientific have announced plans to begin new IDE trials in the US evaluating their next-generation renal denervation platforms. We've got a name from Boston for their trial: REDUCE-HTN-REINFORCE and they've got a penchant for these dramatic trial names (see: PREVAIL trial for the Watchman device). I like it. Medtonic hasn't revealed the name of theirs yet SYMPLICITY HTN-5
Regardless of what these trials are called, there will be important differences from HTN-3:
- The devices that will be evaluated Medtronic's Symplicity Spyral and Boston's Vessix platform are both multi-electrode devices designed to achieve optimal circumferential denervation. What this boils down to, is that both devices allow for multiple simultaneous burn points, at a predetermined distance apart, and in a circumferential manner. Analysis from Dr. Kandzari at PCR last year showed us that this is necessary for complete denervation to occur.
- There's been an emphasis from both companies on limiting confounding factors through trial design. We don't have any concrete information about the design of these trials yet, but one of the main considerations will be ensuring patient compliance and rigorously monitoring their pharma regimens.
Nothing official has been announced in terms of protocol details, but my gut tells me that we'll get more information at the ACC conference in March.
An interesting consequence of these developments is that Boston Scientific may end up being the first renal denervation device to market in the US, if clinical efficacy is supported. The company has already received approval from the FDA for their study design and has stated that it will begin enrollment within a few months. Medtronic, on the other hand, is still in the midst of submitting its IDE proposal and may find itself in an unfamiliar position in this space: second to market.