Reflow Medical, Inc., a leading developer of innovative devices for treating complex cardiovascular disease, announces the presentation of one-year clinical results from the first-in-human DEEPER CORONARY study at Transcatheter Cardiovascular Therapeutics (TCT) 2026, the annual scientific symposium of the Cardiovascular Research Foundation (CRF), in San Diego. The study evaluates the investigational coronary Spur® Elute Sirolimus-Eluting Retrievable Stent System for coronary in-stent restenosis (ISR).

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The results were presented by Kathleen Kearney, MD, FSCAI of Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, on behalf of Scott Harding, MD, Director of the Cardiology Research Group at Wellington Hospital, Wellington, New Zealand, the study’s principal investigator.

DEEPER CORONARY is a single-center, first-in-human pilot study designed to evaluate the short-term safety of the investigational coronary Spur Elute Stent System as a primary treatment for coronary ISR. 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 1.8 mm 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 Dr. Kearney.

“Completing 1-year follow-up in all nine patients is an important milestone,” said Dr. 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 optimize/maximize 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 1-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.

About Reflow Medical, Inc.

Reflow Medical is a global company that partners with leading physicians to develop innovative technologies addressing unmet clinical needs in the endovascular treatment of complex cardiovascular disease. The company’s portfolio includes coronary and peripheral microcatheters, crossing catheters, and its proprietary Retrievable Scaffold Therapy (RST) platform. The coronary Cora Catheters line is FDA cleared. The peripheral product line includes Wingman™, Spex®, and Spex LP®, which have FDA clearance and CE mark, and Spur®, which has received FDA De Novo authorization and CE mark. Reflow Medical is headquartered in San Clemente, California.

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