Reflow’s Spur Elute Retrievable Stent System for ISR Evaluated in DEEPER CORONARY

November 1, 2026—Reflow Medical, Inc. announced that 1-year clinical results from the company’s first-in-human DEEPER CORONARY study were presented at TCT 2026 by Kathleen Kearney, MD, on behalf of Principal Investigator Scott Harding, MD.

DEEPER CORONARY is a single-center pilot study designed to evaluate the short-term safety of Reflow’s investigational coronary Spur Elute sirolimus-eluting retrievable stent system as a primary treatment for coronary in-stent restenosis (ISR).

According to the company, the nine patients treated in the study completed 12-month follow-up. Freedom from major adverse cardiac events and from all-cause mortality was 100% at 1 year, and no unanticipated adverse device effects or device-related serious adverse events were reported. All patients showed improvement in Canadian Cardiovascular Society angina class, with a median improvement of three classes.

Additionally, Reflow stated that device delivery and lesion success (defined as < 30% residual stenosis) were achieved in all nine patients. Mean residual stenosis was 13.3% and mean acute lumen gain was 1.8 mm after treatment with the coronary Spur Elute.

“Coronary ISR remains a significant clinical challenge, particularly in patients with multiple stent layers,” commented Dr. Kearney in Reflow Medical’s press release. “The absence of major adverse cardiac events at 1 year in this first-in-human study is encouraging and supports further evaluation of a treatment approach that combines temporary scaffolding with sirolimus delivery, without leaving another permanent implant behind.”

Dr. Harding added, “Completing 1-year follow-up in all nine patients is an important milestone. While this is a small first-in-human study, the clinical outcomes are reassuring and provide a strong rationale for further investigation of this technology in patients with coronary ISR.”