Reflow Medical has announced presentation of one-year clinical results from the first-in-human DEEPER CORONARY study, evaluating the investigational coronary Spur Elute sirolimus-eluting retrievable stent system for coronary in-stent restenosis (ISR) at the 2026 Transcatheter Cardiovascular Therapeutics (TCT) conference (31 October–3 November, San Diego, USA).
DEEPER CORONARY is a single-centre, first-in-human pilot study designed to evaluate the short-term safety of the investigational system as a primary treatment for coronary ISR.
The results were presented by Kathleen Kearney (Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA), on behalf of the study’s principal investigator Scott Harding (Wellington Hospital, Wellington, New Zealand).
Kearney reported that all nine treated subjects completed 12-month follow-up. Freedom from major adverse cardiac events (MACE) and from all-cause mortality was 100% at one year, and no unanticipated adverse device effects or device-related serious adverse events were reported. All patients showed improvement in Canadian Cardiovascular Society (CCS) angina class, with a median improvement of three classes.
Device delivery and lesion success, defined as less than 30% residual stenosis, were achieved in all nine patients. Mean residual stenosis was 13.3% and mean acute lumen gain was 1.8mm after treatment with the coronary Spur Elute.
“Coronary ISR remains a significant clinical challenge, particularly in patients with multiple stent layers. The absence of major adverse cardiac events at one 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,” said Kearney.
“Completing one-year follow-up in all nine patients is an important milestone,” said Harding. “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.”
The coronary Spur Elute is designed to create microchannels that facilitate drug delivery into the vessel wall, complemented by direct contact sirolimus transfer from the drug-coated scaffold struts and integrated balloon. The temporary scaffold supports the vessel and permits coronary perfusion while the balloon is deflated. Together, these mechanisms are designed to optimise/maximise luminal expansion, enhance drug delivery, and reduce the risk of recurrent restenosis. Following treatment, the system is fully retrieved, leaving no additional metallic implant behind.
“We aim to change how restenosis is treated by combining mechanical vessel support with targeted drug delivery, without leaving additional metal behind,” said Isa Rizk, CEO and co-founder of Reflow Medical. “These one-year results represent an important step in advancing the coronary Spur platform and reinforce our commitment to developing differentiated solutions for complex coronary disease.”
The coronary Spur Elute Sirolimus-Eluting Retrievable Stent System is an investigational device only.
