The story of renal denervation and its spectacular and shocking failure in 2014 is one of the more dramatic narratives in the medical device industry, and one that we at DRG Medtech (and I personally) have been following closely for more than 6 years. With the publication of positive clinical trial results over the past 12 months, the therapy has re-emerged as a potentially lucrative market. Over the next two months leading up to TCT 2018 in San Diego, DRG Medtech will be publishing a blog and opinion series on this technology. We’ll be answering the questions: will there even be a market, and who will be positioned to win in that market?
To kick off our blog series, let’s discuss where we are, and how we got here:
In the early days, there was bubbling exuberance about the potential of this technology to lower blood pressure. In fact, DRG Medtech ranked renal denervation as our #1 medtech story to watch for 2012, and provided a “conservative estimate” of up to $5 billion for the eventual market size. This excitement continued through the following years (Everybody Loves Renal Denervation, DRG Medtech Blog, September 2012), until it all came crashing down in 2014. In January of that year, we learned that the first large-scale pivotal trial failed (Renal Denervation Fails to Catch Fire, DRG Medtech Blog, January 2014), and (Where Has Renal Denervation Gone?, DRG Medtech Blog, October 2014) and the medical community was left wondering what the future held for these devices.
In 2015, multiple clinical trial programs were initiated (A Renal Denervation Sighting, DRG Medtech Blog, February 2015), and over the past 12 months we’ve started seeing results from those trials. Note that all blood pressure reductions cited below are the difference in 24h ambulatory systolic blood pressure observed in the renal denervation group as compared to the sham control group within each trial.
Spyral OFF-Med (Medtronic, presented at ESC 2017)
- Investigated impact of renal denervation for patients who stopped taking medication, to isolate the true effect of the therapy.
- Results showed that there was a significant blood pressure reduction of –5.0 mm Hg in systolic blood pressure (SBP).
- Led to IDE approval of a pivotal trial in April 2018.
Spyral ON-MED (Medtronic, presented at EuroPCR 2018)
- Investigated impact of RDN for patients who continued taking medication throughout the treatment period.
- Results showed that there was a significant SBP reduction of –7.4 mm Hg.
RADIANCE-SOLO (ReCor Medical, presented at PCR 2018)
- Similar to OFF-MED, evaluated patients who stopped taking medication. A key difference was the technology evaluated used ultrasound (rather than RF) energy, and patient compliance measures were not as rigorous.
- SBP reduction of –4.1 mm Hg was observed.
- Led to IDE approval of a pivotal trial in July 2018 and acquisition of ReCor by Otsuka Holdings.
REDUCE HTN: REINFORCE (Boston Scientific, results not presented)
- Trial results have not been presented and trial has been suspended.
The key takeaway of the trial results is this: renal denervation does lower blood pressure, and does so in patients both on and off anti-hypertensive regimens; however, not all platforms and trial designs are created equal. An opportunity has been reborn, but one that must be carefully navigated.
Keep an eye out for future posts in this series, where we’ll discuss some open questions, such as the potential for a class effect for renal denervation platforms, which patients could benefit from this emerging treatment, and finally, what the market opportunity could look like for medtech companies in this space.
Clarification: An earlier version of this blog post failed to specify the specific blood pressure measurements that were cited for each trial. Blood pressure measurements are cited as the difference in 24h ambulatory systolic blood pressure between renal denervation groups and sham procedure groups as presented in the literature publications for each trial. We regret this omission and have since provided clarification to the post above.