A New Tool Being Studied for Severe PAD Below the Knee

When someone is told they’ve run out of options, it’s usually not because nothing exists. It’s because the situation has gotten more complicated and the tools available to that doctor may be limited.

That’s often the case with advanced peripheral artery disease, especially when it’s below the knee.

At a recent medical meeting, doctors shared one-year results from Reflow Medical's study called DEEPER REVEAL. It looked at a different way to treat patients with chronic limb-threatening ischemia, which is the most advanced stage of PAD. These are the patients dealing with non-healing wounds, severe pain, or conversations about amputation.

So what’s different here?

Instead of putting in a permanent stent, this approach uses the Spur Stent System, a device that goes in, helps open the artery and modify the plaque narrowing the artery, and then comes back out. The goal is to improve blood flow without leaving anything behind.

That's important because below-the-knee arteries are small and delicate. They don’t always do well with permanent implants. And once something is left behind, it can limit what doctors can do later if the artery closes again. The retractable stent still gives vascular specialists the option of bypass as a future contingency plan in case endovascular efforts are exhausted because a 'landing zone' is preserved.

In this study, 130 patients were treated across multiple centers in the U.S. At one year, about 78 percent of the treated arteries were still open in the patients who fit the study criteria. Just over 83 percent did not need another procedure in that same area. About 84 percent of patients had their wounds heal, and 80 percent saw improvement in symptoms.

Those are strong results for a group of patients that is usually very difficult to treat.

At the same time, it’s important to understand what this does and does not mean.

This was not a randomized trial. It does not mean this approach is better than everything else. It does not mean every patient is a candidate. The outcomes were measured in vessels that met specific criteria, which your doctor would have to evaluate.

What it does show is that new tools are being developed for patients who often feel like they’ve reached the end of the road.

If you are dealing with below-the-knee disease, or if you’ve been told amputation may be the next step, this is the type of research that should at least be part of the conversation.

Not because it is the answer, but because it may be an option in the right situation.

Questions to ask your doctor

• Do I have disease below the knee, and how complex is it?

• Have all revascularization options truly been explored in my case?

• What are the pros and cons of placing a permanent stent versus not leaving anything behind?

• Are there newer tools or approaches available for arteries like mine?

• Would I qualify for any clinical trials based on my anatomy and condition?

• How do you decide which vessels are appropriate for different techniques?

• Should I be evaluated at a center that specializes in limb salvage?

  
  

One thing to keep in mind

This is here to help you understand what is being studied and what questions you can ask.

It is not a treatment plan.

Your medical team is the one that determines the right tools and techniques based on your specific disease. You can bring this into the conversation, but it does not replace that process.