In the ongoing battle against peripheral artery disease (PAD), a condition more prevalent and deadlier than breast, prostate, and colon cancer combined, one company stands out not just for its revolutionary technology, but for its unwavering commitment to patients. Reflow Medical, recipient of the Global PAD Association's Corporate Champion of PAD Awareness Award and now sponsor of The Heart of Innovation, is pioneering a device that could fundamentally change how doctors treat PAD in the smallest leg arteries.
The Problem: The "Forgotten" Arteries Below the Knee
For millions suffering from critical limb-threatening ischemia (CLTI), the most severe form of PAD, the greatest challenge often lies in the arteries below the knee. These small vessels—often just 2.5mm in diameter but up to 30cm long—present unique treatment challenges that many physicians simply won't attempt to address.
"Many physicians still say 'there's nothing we can do' for below-the-knee blockages," explained Dr. John Phillips during the Heart of Innovation interview with Reflow Medical CEO Isa Rizk. "They either tell patients to walk until they can't anymore, or they move straight to amputation."
The reason? Current treatment options for these small vessels are limited and often temporary. Traditional stents are not indicated for use in these tibial vessels, and if used off label and left permanently in these arteries, they frequently re-block, while balloon angioplasty alone may not provide lasting results. This has led to a treatment gap where patients with below-the-knee disease often face amputation as their only option.
The Game-Changer: SPUR Retrievable Scaffold Technology
Enter Reflow Medical's SPUR technology—a retrievable stent that could transform treatment approaches. Unlike traditional stents that remain permanently in the artery, the SPUR device:
- Deploys like a conventional stent to open the blocked artery
- Features 96 small spikes that fracture calcified plaque and create channels for drug delivery
- Allows blood flow while deployed
- Can be completely retrieved and removed after treatment
- Leaves behind no permanent implant
"Imagine a woman's hairbrush with spikes—that was the original concept," Rizk explained. "When you open it up inside the artery, these spikes dig into the arterial wall where the disease is, creating channels and breaking up calcified plaque."
The revolutionary aspect? After opening the blockage, the entire device is resheathed and removed, leaving no foreign body behind while maintaining the artery's newly restored opening.
Why This Matters: Changing the Treatment Paradigm
The implications of this technology extend far beyond its innovative design. By providing a new option for treating below-the-knee disease with potentially better long-term outcomes, the SPUR could:
1. Convince reluctant physicians to treat these vessels - Many doctors currently avoid below-the-knee interventions because existing options have limited durability
2. Reduce amputation rates - By providing effective treatment for vessels previously considered untreatable
3. Expand treatment to more patients - Potentially allowing intervention earlier in the disease process, before wounds develop
"We chose below the knee because everybody else failed and we love the challenge," Rizk shared. "What's exciting is we're showing north of 80 percentile of patients not experiencing re-occlusion or needing to come back in."
Dr. Phillips noted: "Will there be a day because of technologies such as what Isa has that we actually treat these patients who have just pain when they walk? That's my hope. And that's why I think this device can help get us there."
Beyond Technology: A Mission to Educate and Advocate
What distinguishes Reflow Medical isn't just its innovative technology. The company has demonstrated exceptional commitment to PAD awareness and education, which earned them the Global PAD Association's Corporate Champion of PAD Awareness Award.
"We're all in on CLTI. We're all in on education. We're all in on training," emphasized Rizk. "We're going to start a huge initiative on education and training. And it's not educating and training relative to just our technologies. It's actually the therapy and the treatment modality and what is being done for CLTI patients."
This commitment extends to supporting patient advocacy efforts, including stepping in to sponsor The Heart of Innovation program when its future was uncertain.
Looking Forward: The Path to Patient Access
The SPUR technology has already received approval in Europe and is currently under review by the FDA in the United States, with potential approval anticipated sometime this year. In clinical studies, including initial work in the Dominican Republic, the technology has shown promising results in wound healing and improved walking ability.
"We got to see the patients from day one when we treated them all the way out to one year," Rizk said, describing the company's early clinical work. "The ones that would come in limping, but they'd be walking out... seeing a wound heal over time is probably one of the most rewarding things you can see from a patient's perspective."
Expanding to Coronary Applications: Tackling In-Stent Restenosis
While Reflow Medical's initial focus has been on the critical needs of PAD patients, the company is also exploring applications for their SPUR technology in coronary arteries. Specifically, they're targeting in-stent restenosis—a significant challenge where previously placed heart stents become blocked again, often requiring additional stent placements.
"Our focus in the coronaries today is in-stent restenosis," Rizk explained. "We're going with the low-hanging fruit. The fact that we don't want to see layers and layers of stents going in when there is an occlusion. It's a smaller piece of the broader market, but it's a big unmet need."
This application could provide interventional cardiologists with a valuable new tool for treating occluded stents without adding additional permanent implants. The same spike technology that creates channels for drug delivery in leg arteries could potentially improve outcomes for heart patients facing the frustrating cycle of repeated stent procedures. This demonstrates how innovations initially developed for the "forgotten" PAD space can sometimes lead to advances for the more established coronary market.
Why Watch the Full Interview
This blog only scratches the surface of the fascinating conversation between Rizk, Dr. Phillips, and host Kym McNicholas. The full interview delves deeper into:
- The engineering challenges behind creating a retrievable stent
- How the SPUR technology works in detail
- The company's vision for education and changing physician mindsets
- Potential future applications in coronary arteries
- The personal stories driving Reflow Medical's passion for PAD awareness
For anyone interested in the future of PAD treatment, the fight against unnecessary amputations, or innovative medical technology, the complete interview offers invaluable insights from both clinical and engineering perspectives.
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To watch the full interview with Reflow Medical CEO Isa Rizk on The Heart of Innovation, click the link above. And remember, if you or a loved one is facing PAD, especially with symptoms below the knee, always seek a second opinion before accepting amputation as the only option. Call the Global PAD Association’s Leg Saver Hotline 1-833-PAD-LEGS to get answers about PAD, for real-time support, and for assistance finding a doctor who has advanced limb salvage options available such as the SPUR technology to give you and/or your loved one another chance at walking to live another day and living to walk another day.
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