Reflow reports early DEEPER CORONARY data for ISR device
Bottom line
Reflow Medical said its first-in-human DEEPER CORONARY study of the Spur Elute coronary sirolimus-eluting retrievable scaffold has reported results in patients with coronary in-stent restenosis, a repeat-narrowing problem that occurs inside previously placed stents. The company previously said the pilot study enrolled nine patients and was designed to evaluate treatment of the target lesion without in-hospital major adverse cardiac events, with lesion success and 30-day safety as secondary endpoints. Reflow has positioned Spur Elute as a “leave nothing behind” approach: a temporary, drug-coated scaffold with expandable spikes that is removed after delivering therapy, rather than adding another permanent metal layer. The study was slated for first clinical presentation at TCT 2025, where Scott Harding, MD, was listed to present early first-in-human results. (businesswire.com)
Why it matters: Coronary ISR remains a meaningful workload and repeat-procedure burden in interventional cardiology, and multiple stent layers are associated with a higher risk of recurrent restenosis. Current ISR management often relies on drug-coated balloons or repeat drug-eluting stents, with European guidance supporting drug-coated balloons for ISR, so any technology that aims to improve drug uptake while avoiding another permanent implant will draw attention from clinicians watching durability, safety, and reintervention rates. For veterinary professionals, the broader lesson is familiar: device developers are still trying to solve restenosis by balancing acute lumen gain against long-term tissue response and implant burden. (mdpi.com)
What to watch: The next key questions are whether Reflow publishes full DEEPER CORONARY outcome data in a peer-reviewed venue, expands beyond this nine-patient pilot, and shows durable follow-up beyond the early safety window. (businesswire.com)
Reflow Medical is reporting results from its DEEPER CORONARY first-in-human study of the Spur Elute stent system for coronary in-stent restenosis, a difficult reintervention setting where clinicians are often trying to restore lumen size without creating yet another permanent metal layer. The company has described Spur Elute as a sirolimus-eluting, retrievable scaffold system intended to treat ISR and then be fully removed, making it a distinctly different proposition from conventional repeat stenting. (businesswire.com)
The backdrop is a persistent clinical problem. Coronary ISR still accounts for a notable share of repeat coronary procedures, even in the drug-eluting stent era, and the challenge gets harder as metal layers accumulate. Reviews in JACC and other journals have noted that recurrent ISR risk rises with multiple metallic layers, which is one reason “leave nothing behind” strategies such as drug-coated balloons have gained traction. Recent reviews also note that drug-coated balloons have a Class I recommendation in Europe for ISR treatment, although practice still varies by lesion type and operator preference. (mdpi.com)
What Reflow has disclosed so far is still limited, but several details are clear. In September 2025, the company announced completion of enrollment in DEEPER CORONARY with nine treated subjects and one year of planned follow-up. The primary endpoint was treatment of the target lesion with the investigational device without in-hospital major adverse cardiac events, while secondary endpoints included lesion success and 30-day safety. Reflow said the device combines a self-expanding retrievable scaffold, radially expandable spikes, an integrated balloon, and sirolimus coating intended to create channels that increase drug uptake into the vessel wall before the system is removed. (businesswire.com)
There is also evidence that the company moved quickly to put the data on the conference circuit. The TCT 2025 program lists an Innovation session presentation titled “A Novel Drug-Eluting Retrievable Scaffold for Coronary In-Stent Restenosis (Reflow Medical): Early First in Human Results,” presented by Scott Harding, MD, on October 26, 2025. That confirms the study advanced beyond enrollment and into public scientific presentation, even though detailed numerical outcomes were not readily available in the sources reviewed here. (assets.crfconnect.com)
Company-aligned experts have framed the technology around a familiar ISR concern: how to suppress neointimal hyperplasia and recoil without committing the artery to another permanent implant. In Reflow’s enrollment announcement, William Lombardi, MD, said ISR carries substantial healthcare costs and is associated with increased risks of death and rehospitalization, while Harding said preliminary results were encouraging and highlighted the potential to address ISR “without leaving another stent behind.” Those are useful signals on intended positioning, though they should still be read as sponsor-associated commentary until full peer-reviewed data are available. (businesswire.com)
Why it matters: For veterinary professionals following device innovation, this story is less about coronary practice directly and more about the translational pattern. Restenosis remains one of the enduring engineering and biologic problems in vascular intervention: enough radial force is needed to open the vessel, but permanent implants can add chronic irritation, layered hardware, and future treatment complexity. Reflow’s approach tries to split those goals, using temporary mechanical scaffolding plus local sirolimus delivery, then removing the device. If that concept proves durable, it could strengthen the broader case for temporary scaffolds and targeted drug delivery in vascular disease, including areas where repeat intervention and implant burden are major concerns. (businesswire.com)
What to watch: The immediate next step is fuller disclosure: quantitative DEEPER CORONARY results, 30-day and 1-year outcomes, and ideally publication in a peer-reviewed journal. After that, the field will want to see whether Reflow launches a larger study, how the device compares with established ISR options such as drug-coated balloons and repeat DES, and whether regulators eventually see enough evidence to support a broader coronary pathway. For now, the concept is intriguing, but the evidence base still appears early and sponsor-led. (businesswire.com)