The renal denervation market will see significant development after the first device is approved by the FDA.
DRG cardiovascular expert Sean Messenger reviews:
- What key factors that will influence the market
- Implications for new players entering the space
So, given the recent clinical data that has come out over the last year and a half, we do see that there will be a renal denervation market within the next few years when the first device is approved by the FDA, once the current pivotal trial has published results. How this market develops will really depend on the results of the trial and the magnitude of the benefit that we see from renal denervation. The higher the benefit, the more likely payers are to fund that procedure, whether that's government payers or private payers.
So, the market is likely to depend on a few different things. One of the most important is the actual patient profile of those who will benefit from renal denervation therapy, and there are several types of patients who could benefit, depending on the magnitude of the effect of this treatment. The other thing that will be really interesting to watch is the competitive landscape within the renal denervation market.
Right now there are two technologies that are being evaluated: radiofrequency technology marketed by Medtronic and an ultrasound technology being developed by ReCor Medical. And, we've seen that not all technologies are created equal. Boston Scientific actually had a platform called Vessex, and the Vessex trial had to be suspended due to lack of efficacy for the device. And so, it's not going to be a market that can easily be jumped into by any manufacturer. They have to go through a very rigorous process of researching and developing their device and going through a rigorous clinical trial program.