Reflow Medical, Inc., a leading developer of innovative devices for treating complex cardiovascular disease, announces the presentation of the first six-month clinical results from the DEEPER CORONARY study at EuroPCR 2026 in Paris, France. The study evaluates the investigational coronary Spur® Elute Sirolimus-Eluting Retrievable Stent System for coronary in-stent restenosis (ISR).
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The data was presented by Scott Harding, MD, Director of the Cardiology Research Group at Wellington Hospital, Wellington, New Zealand, and principal investigator for the DEEPER CORONARY trial.
DEEPER CORONARY is a first-in-human pilot study designed to evaluate the short-term safety of the investigational coronary Spur Elute System as a primary treatment for coronary ISR. Six-month study results showed 100% freedom from MACE and 100% freedom from all-cause mortality among nine treated subjects. Improvement in CCS angina class was observed in all patients, with a median improvement of three classes.
“The six-month data from DEEPER CORONARY provide encouraging acute and mid-term safety and efficacy results utilizing the investigational Spur Elute system,” said Scott Harding, MD. “These early findings support the continued clinical evaluation of this retrievable, sirolimus-eluting stent approach in ISR and further potential for CAD treatment.”
The coronary Spur Elute Stent System is the first and only retrievable self-expanding stent with radially expandable spikes, combined with an integrated balloon, both of which are drug-coated with a sirolimus drug formulation unique to Reflow Medical. Known as Retrievable Scaffold Therapy (RST), the Spur Elute spikes create channels to increase uptake of the antiproliferative drug into the vessel wall, while the temporary stent supports the arterial lumen. Together, these mechanisms are intended to maximize luminal diameter and reduce the risk of restenosis. The system is then fully removed without leaving a permanent metallic implant behind.
“These encouraging results are an important milestone for our coronary program designed to benefit patients suffering from coronary disease,” said Isa Rizk, CEO and Co-Founder of Reflow Medical. “We thank Professor Harding, the investigators, and our partners for advancing this first-in-human study and the continued evaluation of the coronary Spur Elute.”
The coronary Spur Elute Sirolimus-Eluting Retrievable Stent System is an investigational device only.
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 approved. The peripheral product line includes Wingman™, Spex®, Spex LP, and Spur®, which have FDA clearance and CE Mark registration. Reflow Medical is headquartered in San Clemente, California.
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