Reflow reports early DEEPER CORONARY data for ISR device

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)