What was most interesting to me about Ra Medical System's FDA study for the DABRA Laser System, was that they designed it for only those patients who didn't have other options. Basically, only the cases in which a CTO couldn't be crossed with a guidewire. All but one other device on the market requires a guidewire in order to create a channel through a blockage.
It was surprising to me that they would choose to only tackle those CTO's that couldn't be crossed with a guidewire because a 510(k) is about proving equivalency to a product already on the market. They could've taken the path of least resistance as the other laser can't cross without tracking a guidewire.
The CEO Dean Irwin told me, "We did this because we set out to design a device that we hoped would not just improve patient outcomes compared to other similar devices, but to do what no one else has been able to do, and treat those patients who were on the verge of amputation."
And it turns out that he was right in taking this approach, because as UCSD's Chief of Cardiovascular Medicine explains below, that in order to truly have an impact on this market, you need to address those cases in which "there's nothing else we can do."
In many cases I witnessed over the course of not only the FDA study, but around the world, there were actually vascular surgeons on standby to amputate in case the DABRA Laser System didn't work.