SAN CLEMENTE, Calif.–Reflow Medical has reported encouraging one-year clinical results from an early-stage study of its investigational coronary Spur Elute Sirolimus-Eluting Retrievable Stent System, with all nine patients remaining free of major adverse cardiac events and no deaths reported during the follow-up period.
The findings from the first-in-human DEEPER CORONARY study were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2026, the annual scientific symposium of the Cardiovascular Research Foundation, held in San Diego.
The study evaluated the experimental device as a treatment for coronary in-stent restenosis (ISR), a condition in which an artery becomes narrowed again after a previous stent procedure.
The results were presented by Kathleen Kearney, M.D., FSCAI, of Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, on behalf of Scott Harding, M.D., Director of the Cardiology Research Group at Wellington Hospital in New Zealand and the study’s Principal Investigator.
DEEPER CORONARY is a single-center pilot study designed to assess the short-term safety of the investigational coronary Spur Elute system in patients experiencing narrowing within previously implanted coronary stents.
All nine participants completed the 12-month follow-up period. According to the company, none experienced major adverse cardiac events or died during the study period. Researchers also reported no unexpected adverse device effects or serious device-related complications.
All patients demonstrated improvement in their Canadian Cardiovascular Society angina classification, a measure used to assess the severity of chest pain associated with coronary artery disease. The median improvement was three classes.
The study also reported successful device delivery and treatment of the targeted arterial narrowing in all nine patients.
Researchers achieved less than 30% residual stenosis in every participant, with an average remaining narrowing of 13.3% following treatment. The mean acute lumen gain, a measure of the increase in the artery’s internal diameter, was 1.8 millimeters.
“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.
Unlike conventional permanent coronary stents, the Spur Elute system is designed to temporarily support the artery while delivering sirolimus, a medication used to help prevent tissue growth that can contribute to renewed arterial narrowing.
The device creates small channels in the vessel wall to facilitate drug delivery. A drug-coated scaffold and integrated balloon provide additional contact with the arterial surface, allowing sirolimus to be transferred directly to the treatment area.
The temporary scaffold is designed to maintain vessel support and allow blood flow while the balloon is deflated. After treatment, the entire system is removed, leaving no additional metallic implant inside the artery.
The approach is intended to address a challenge in treating patients who already have multiple layers of coronary stents, where placing another permanent implant may complicate future treatment.
“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.”
Reflow Medical, based in San Clemente, California, develops medical devices intended to treat complex cardiovascular conditions, including coronary artery disease.
“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, Chief Executive Officer 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.”
Although the initial findings suggest the device may offer a potential alternative for treating coronary in-stent restenosis, the study involved only nine patients and was designed primarily to evaluate safety. Larger clinical studies will be needed to establish its effectiveness and longer-term outcomes.
The coronary Spur Elute Sirolimus-Eluting Retrievable Stent System remains an investigational device and is not approved for commercial use.
