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CMS Approves NTAP for Reflow’s Spur System

NTAP

Reflow Medical recently shared that CMS has granted the Spur peripheral retrievable stent system a New Technology Add-on Payment, confirming the Reflow Medical Spur NTAP payment that will provide additional reimbursement for eligible fee-for-service Medicare inpatient cases beginning Oct. 1, 2026.

What the Reflow Medical Spur NTAP Payment Actually Provides

Under the fiscal year 2027 NTAP programme, qualifying inpatient cases involving the Spur stent system are eligible for an incremental payment up to $2,596.75, in addition to the applicable Medicare severity diagnosis-related group payment. Reflow states that actual payment is determined on a case-by-case basis in accordance with the applicable CMS and NTAP methodology used, and the NTAP is available for a period of up to two years.

Why This Add-On Structure Matters for Hospital Adoption

“NTAP is designed to help hospitals adopt new technology by reducing any financial barriers when introducing clinically meaningful innovations,” said Jill Joines, director of market access and health economics for Reflow Medical. “By recognising the added costs of qualifying new technologies, NTAP supports timely patient access for Medicare beneficiaries while hospitals gain experience with the technology.”

What the Spur System Is Designed to Treat

The Spur stent system is intended as an adjunct to percutaneous transluminal angioplasty to dilate stenoses in infrapopliteal arteries ranging in diameter from 2.5 to 4.5mm. The Spur stent provides temporary mechanical scaffolding and is retrieved following treatment, leaving no permanent implant behind.

Why the Retrievable Design Distinguishes This Device

Unlike traditional stents that remain permanently implanted, the Spur system’s retrievable design offers physicians a temporary scaffolding option, potentially reducing the long-term complications associated with permanent implants while still providing the mechanical support needed during the acute treatment window.

The Regulatory Path Behind This Reflow Medical Spur NTAP Payment

The Spur stent system was granted De Novo classification by the FDA in May 2025, following its earlier FDA Breakthrough Device designation. This progression from breakthrough designation to De Novo classification and now to CMS reimbursement approval reflects a relatively swift regulatory pathway for a device addressing what the company describes as a significant unmet clinical need.

Why This Milestone Matters for Reflow Medical

“This is an important milestone for Spur and for our continued efforts to support physicians treating patients with infrapopliteal arterial disease, a population with significant unmet clinical needs,” said Isa Rizk, CEO and co-founder of Reflow Medical.

What This Reflow Medical Spur NTAP Payment Means for Hospitals

With reimbursement now available for qualifying Medicare fee-for-service inpatient cases starting Oct. 1, hospitals already using or considering the Spur system have a clearer financial pathway to offset the cost of deploying this device for patients with infrapopliteal arterial disease. Given the two-year NTAP eligibility window, hospitals adopting the device now can factor predictable incremental Medicare reimbursement into their return-on-investment calculations for a meaningful planning horizon before the add-on payment period concludes.

How This Fits the Broader Peripheral Vascular Device Landscape

This approval adds to a broader pattern of new technology add-on payments and reimbursement milestones reaching the peripheral vascular device space in 2026, alongside developments like Terumo Aortic’s new DRG 209 for complex aortic arch procedures. Given the persistent shortage of effective, minimally invasive treatment options for infrapopliteal arterial disease, particularly among patients with chronic limb-threatening ischemia, this reimbursement pathway may accelerate broader physician adoption of retrievable stent technology as an alternative to permanent implants in this specific vascular territory.

What to Watch Going Forward

As the Oct. 1 effective date approaches, industry observers will likely watch how widely hospitals adopt the Spur system for treating infrapopliteal arterial disease now that this reimbursement pathway is in place. Given Reflow Medical’s continued clinical trial work, including its DEEPER REVEAL trial data, this Reflow Medical Spur NTAP payment may support broader clinical evidence generation as more hospitals gain experience with the device during the two-year reimbursement window, potentially strengthening the case for continued coverage once the NTAP period expires.

Given that infrapopliteal arterial disease disproportionately affects patients with diabetes and peripheral artery disease, populations that often face limited revascularization options due to small vessel diameters and high restenosis rates, the real-world uptake of the Spur system during this NTAP window could offer meaningful insight into whether retrievable stent technology represents a durable alternative to existing below-the-knee treatment approaches. Vascular specialists and hospital administrators evaluating whether to adopt the device may also watch for updated guidance from professional societies as more clinical experience with the Spur system accumulates under this new reimbursement structure.

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Written by

The DistilINFO Editorial Team covers healthcare payer, provider, government health, life sciences and health AI news for more than 135,000 industry decision makers. Since 2016, DistilINFO has published daily briefings that summarize the developments that matter most to health plans, health systems and the organizations that serve them. Our stories are based on primary sources, including press releases, regulatory filings, CMS and HHS announcements, and peer-reviewed research, which we cite and link in every article. Questions or corrections: digital@distilinfo.com.

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