By Kym McNicholas
You might remember that viral video where Coach Prime, Deion Sanders, revealed his vascular surgeon believed amputation was inevitable for him because while they could open the small arteries that were blocked below his knee, those vessels would just simply close up again. As the doctor put it, “Well, you can get them open, but the chance of keeping them open are not very good.” While Sanders was never diagnosed with peripheral artery disease (PAD) specifically—doctors have publicly explained his condition as blood clots due to hypercoagulability—his story highlights a critical challenge in vascular medicine: how to effectively treat small arteries below the knee that tend to close up again after intervention.
Understanding Peripheral Artery Disease (PAD)
Before diving into this breakthrough technology, it’s important to understand what PAD is and why it matters. Peripheral artery disease is a circulatory condition where narrowed arteries reduce blood flow to the limbs, particularly the legs. Despite being more prevalent and deadlier than breast cancer, colon cancer, and prostate cancer combined, PAD remains largely under-diagnosed and under-treated.
Symptoms of PAD include leg pain when walking (claudication), neuropathy, leg cramps, and cold feet. When PAD reaches its advanced stage, known as critical limb ischemia (CLI) or critical limb-threatening ischemia (CLTI), patients experience wounds that won’t heal and severe rest pain that often wakes them up at night. The only relief comes from dangling their legs over the side of the bed or pacing the floor.
The statistics are alarming: every four minutes, there is an amputation in this country due to PAD and diabetes (every 20 seconds globally). We also know that 85% of these amputations are preventable with early intervention.
What’s truly shocking is that according to a study published in the American Heart Association’s Circulation journal, more than 60% of all amputations in the U.S. are performed without a doctor ever conducting an appropriate angiogram prior to amputation. This mirrors what we’ve seen through the Global PAD Association’s Leg Saver Hotline. Among more than 1,000 patients who contacted our hotline while facing imminent amputation, 85% were either not offered an angiogram at all or were told the vessels below the knee were too small to treat so doctors wouldn’t even try. This is precisely the same rationale that Deion Sanders’ doctors initially gave him about his small vessels below the knee.
Why Doctors Dismiss Below-Knee Interventions
As you can see, the true Achilles heel of treating advanced PAD, leading to the majority of amputations, has been effectively addressing blockages in the small arteries below the knee. These tiny vessels are particularly challenging to treat because traditional interventions often fail to provide durable results, leading to a revolving door of expensive procedures that many doctors believe merely delay the "inevitable" amputation.
The most common objection I hear from vascular specialists? "The vessels are simply too small to treat effectively." Below-the-knee arteries are not only tiny, but in patients with diabetes and chronic kidney disease, they're typically long, diffusely diseased, and heavily calcified. Without effective scaffolding, these vessels quickly recoil after balloon angioplasty, leading to frustratingly high restenosis rates.
Some physicians have turned to atherectomy devices—particularly laser atherectomy—to remove plaque and prepare these challenging vessels before angioplasty to lower barometric pressure and ultimately risk of vessel dissections. While these techniques have shown promise in certain cases, the evidence supporting their widespread use below the knee remains limited and somewhat controversial. They may prepare the vessel nicely, but without addressing the recoil problem, long-term results are still inconsistent.
This has created a significant therapeutic gap. Until recently, physicians had no dedicated stenting options for these vessels. Some determined doctors tried using coronary stents off-label but discovered a critical limitation: stents placed in the distal portions of the calf—areas without the protection of surrounding bone structure—faced substantial risk of being crushed by normal leg movement.
The Abbott Espirit bioabsorbable stent represents a breakthrough for short BTK lesions, offering temporary scaffolding that eventually dissolves. But many patients with critical limb ischemia have longer, more complex disease patterns that would require multiple stents—an approach that's not only costly but technically challenging and still vulnerable to crushing forces in distal segments.
This reality creates that costly revolving door, where patients return repeatedly for interventions with diminishing returns each time.
Here's what's fascinating though—while many doctors see this "revolving door" of repeated procedures as problematic, patients often have a completely different perspective. When faced with the alternative of amputation, most patients gladly accept the need for multiple interventions if it means keeping their limb. For them, each procedure buys precious time and maintains quality of life, even if the medical system sees it as costly and inefficient.
But what if there was a better way where both the patient and physician could have their way? What if we could provide the benefits of a stent without leaving metal in the body forever?
A Medical Breakthrough: The First Retrievable Stent System
That’s exactly what Reflow Medical has accomplished with their groundbreaking SPUR peripheral retrievable stent system, which recently received FDA de novo clearance. This innovative technology represents a significant advancement for patients with PAD, especially those with blockages in the small arteries below the knee.
As an Emmy award-winning journalist who has covered medical innovations for years, I’ve seen many new technologies come and go. But this one feels different. The SPUR system is the first and only retrievable stent system that features a self-expanding stent with an integrated dilatation balloon catheter. What makes it truly revolutionary is that it can be completely removed after opening blocked arteries, leaving nothing behind while still appearing to achieve stent-like results.
How Does a Removable Stent Work?
On our award-winning show “The Heart of Innovation,” where I co-host with Interventional Cardiologist Dr. John Phillips, we recently spoke with Interventional Cardiologist Dr. Jay Matthews, principle investigator for the DEEPER REVEAL clinical trial that led to this FDA clearance. Dr. Phillips also shared his experience as the first physician in Ohio to use this device since its clearance.
As Dr. Matthews explained, the SPUR stent has radially expandable spikes that penetrate the lesion to increase the acute luminal diameter and modify the lesion morphology. This changes vessel compliance and reduces the vessel recoil effect that often leads to re-narrowing.
“It’s a combination of factors,” Dr. Matthews told us. “The retrievable stent has an integrated balloon. When you unsheathe or expose the stent, it expands outward. Those spikes start to penetrate into that wall. And then the balloon is inflated, and it pushes those spikes in.”
These below-the-knee vessels, which often recoil after traditional balloon angioplasty, have a layer of calcium underneath soft tissue in the wall. Dr. Matthews explained that “by essentially puncturing that calcium and creating all these micro fractures, it makes the vessel a lot more pliable and flexible.”
What’s truly remarkable is that after this treatment – which takes about six minutes – the stent can be completely removed, yet the vessel maintains its expanded shape instead of recoiling closed as often happens with traditional balloon angioplasty.
Impressive Clinical Results
The results from the DEEPER REVEAL trial were impressive, with the SPUR stent system achieving a 99.2% technical success rate and 97% freedom from major adverse limb events and perioperative death at 30 days.
My co-host Dr. Phillips shared his personal clinical experience using the device: “The case that we just did, we treated all three vessels – the anterior tibial, posterior tibial, and peroneal arteries. From the time I started the first vessel to finishing the last one, it was about 40 minutes. And the posterior tibial artery, 40 minutes after the procedure, looked pretty darn good, honestly.”
This is significant because with traditional balloon angioplasty, physicians often worry about what the vessel will look like just 10-15 minutes after the procedure due to recoil.
Why This Matters for Patients
For patients with advanced PAD, the SPUR technology represents a significant advancement in their treatment options. When the disease has progressed to the point where walking therapy alone isn’t enough, interventional procedures become necessary. This is where the SPUR system can make a crucial difference.
What makes this technology a potential game-changer for patients:
It provides stent-like results without leaving metal behind permanently
It allows for future retreatment if needed, without layers of metal in the way
It appears to provide more durable results than traditional balloon angioplasty
It can treat multiple vessels with a single device
For patients living with advanced PAD who face the prospect of amputation, technologies like this represent new hope for limb preservation. By providing more durable results in these challenging below-the-knee vessels, the SPUR system may help significantly reduce the number of amputations performed.
As I always emphasize in our “Go With The Flow” initiative, walking remains the best medicine for PAD. Patients need to walk, walk, walk to grow collateral vessels that reroute blood flow around blockages. But when walking therapy isn’t enough and interventions are needed, having more effective options like the SPUR system is crucial.
Important Considerations
The SPUR technology represents an exciting advancement, but as with any innovation, it’s part of an ongoing journey. As Dr. Matthews himself acknowledged in our conversation, “I’m not going to tell you that this device is going to be the end all be all.” This honest assessment reminds us that no single technology completely solves the complex challenges of treating below-the-knee PAD.
The current results from clinical trials are promising, with six-month data looking good and Dr. Matthews even mentioning a patient whose treated vessel remained open a year later. However, we’ll need more comprehensive long-term results to fully understand how durable these treatments are compared to other interventions. I’ll be watching closely as the twelve-month data becomes available, and I know many in the medical community will be too.
There are also practical considerations around how the device is used. My co-host Dr. Phillips demonstrated that a single device could treat multiple vessels – he treated three arteries with one device in his case. While this versatility is impressive, it raises questions about potential overuse beyond the intended design and indication, especially since the device is already approved and reimbursed.
The upcoming drug-coated version of SPUR will likely address some of these concerns by nature of becoming a single-use device. This, along with the development of longer versions that Dr. Matthews alluded to, should help ensure the technology is used as intended while providing physicians with more options for different anatomies and lesion types.
Perhaps the biggest hurdle isn’t technological but changing established mindsets. Many physicians have been reluctant to treat below-the-knee vessels due to poor historical outcomes. As Dr. Matthews noted, “I think there are still going to be a lot of naysayers out there and people that aren’t 100 percent on board because we haven’t had great durable therapies until recently.”
The real test for SPUR will be its performance in everyday clinical settings across diverse patient populations, beyond the controlled environment of a clinical trial. Will it convince more physicians to attempt limb salvage for patients who might otherwise face amputation? That’s the question that matters most to patients.
What I find most encouraging is how both Dr. Matthews and Dr. Phillips speak about this technology. They’re experienced physicians who have used countless devices throughout their careers, and they’re genuinely excited about SPUR’s potential while still being candid about where improvements can be made. That kind of enthusiasm from experts who are on the front lines of treating PAD gives me hope that we’re truly seeing a meaningful advancement in the fight to save limbs and lives.
Looking to the Future: Beyond the First Generation
While the immediate focus is on the current SPUR system and its upcoming drug-coated iteration, the long-term potential of this technology extends much further. Dr. Matthews’ excitement was palpable when he discussed broader applications beyond PAD treatment.
“The sky’s the limit,” Dr. Matthews told us. “Bigger vessels, veins, dialysis patients. There’s so many different applications.” This versatility could eventually make the SPUR technology valuable across multiple areas of vascular medicine, not just for PAD patients.
The potential application in coronary arteries is particularly intriguing. The same retrievable stent technology has already been developed for use inside stents in the coronary arteries, potentially addressing significant challenges in coronary interventions where layers of metal can accumulate over time with repeated treatments.
What makes this technology especially promising is how it represents a truly novel approach rather than just an incremental improvement on existing devices. After ten years of development and clinical testing, Reflow Medical has created something that fundamentally changes how we think about stenting and vessel treatment.
As Dr. Matthews put it, “This is just the beginning.” For patients struggling with vascular disease across multiple systems, that’s an exciting prospect indeed.
But I think Dr. Phillips quote from Reflow Medical’s SVP Guenter Haines is appropriate to conclude here, “We’re not into products. We’re into patients.” This philosophy represents exactly what medical innovation should be about - putting people before profits and finding solutions to “impossible” problems.
For more information about PAD and treatment options, visit Global PAD Association or call the Global PAD Association’s Leg Saver Hotline at 1-833-PAD-LEGS. And remember – keep walking!
Disclosure: Reflow Medical is a sponsor of our “Heart of Innovation” show. As an Emmy award-winning journalist, I would never accept a sponsorship from a company if I did not believe in their mission. This article about their FDA clearance was created with complete journalistic integrity because I truly believe, as the FDA did in granting their de novo clearance, that this technology represents a significant advancement for patients with PAD.
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