Reflow Medical’s Spur Stent Gains FDA De Novo Clearance

The FDA has granted De Novo clearance — a regulatory pathway reserved for first-of-a-kind medical devices with no existing equivalent — to Reflow Medical’s Spur Peripheral Retrievable Stent system for the treatment of de novo or restenotic lesions in patients with infrapopliteal arterial disease following balloon angioplasty.

Commonly referred to as below-the-knee (BTK) disease, this condition affects arteries in the lower leg and presents a significant challenge in patients with chronic limb-threatening ischemia (CLTI), a severe form of peripheral arterial disease (PAD).

The Spur system is a novel endovascular device that combines a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system.

It uses a design known as retrievable scaffold therapy (RST), featuring radially expandable spikes that mechanically engage the arterial wall. These spikes help widen the vessel and modify its mechanical properties — making the artery more compliant and reducing its tendency to recoil or re-narrow after balloon angioplasty.

Unlike conventional permanent stents, the Spur system is retrieved once the lesion has been treated, avoiding long-term exposure to a permanent implant.

These design features could address long-standing challenges in both peripheral and coronary interventions, where under-expansion, vessel recoil (the natural tendency of an artery to spring back or collapse inward after it has been mechanically expanded) and restenosis (tissue overgrowth) continue to affect long-term outcomes.

While balloon angioplasty remains a standard treatment, data show limited durability. For instance, a meta-analysis found that treated vessels remained open in only about 63% of cases at follow-up — a benchmark known as primary patency — with nearly 15% requiring major amputation. This highlights a need for more effective vessel remodeling tools during intervention.

The DEEPER REVEAL trial enrolled 130 patients across 49 US sites to evaluate Spur’s safety and effectiveness after predilatation (balloon expansion to prepare the vessel). It achieved a 99.2% technical success rate and 97.0% freedom from major adverse limb events (MALE) and perioperative death (POD) at 30 days. These results suggest Spur may enhance outcomes when used alongside current endovascular strategies.

The FDA’s decision comes amid rising interest in vessel-sparing therapies. In 2024, the agency also approved Abbott’s Esprit BTK system, the first dissolvable stent cleared for BTK use. Like Spur, it aims to support vessel healing without leaving a permanent metallic implant.

Two-year results from the LIFE-BTK trial showed 90.3% of Esprit BTK-treated patients avoided reintervention, with a 48% reduction in repeat procedures compared to balloon angioplasty. The study also found that fewer patients experienced serious complications caused by CLTI like non-healing ulcers, severe pain or amputation at two years.

Based on 2017-2018 Medicare data, an estimated 480,000 Americans were living with CLTI. Among adults over the age of 70, PAD affects up to 15%, with CLTI representing a smaller but high-risk subset. Without timely intervention, patients with CLTI face serious outcomes — up to 25% may die within one year, and many remain at risk for major amputation or other complications.

Reflow Medical plans to launch Spur through its US commercial team. CEO and co-founder Isa Rizk said in the press release, “We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients.”

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