The first six-month clinical results from the DEEPER CORONARY study were presented at EuroPCR 2026 (19–22 May, Paris, France), Reflow Medical has announced. The study evaluates the investigational coronary Spur Elute sirolimus-eluting retrievable stent system for coronary in-stent restenosis (ISR).
The data were presented by Scott Harding (Wellington Hospital, Wellington, New Zealand), 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 major adverse cardiovascular events (MACE) and 100% freedom from all-cause mortality among nine treated subjects. Improvement in Canadian Cardiovascular Society (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 utilising the investigational Spur Elute system,” said Harding. “These early findings support the continued clinical evaluation of this retrievable, sirolimus-eluting stent approach in ISR and further potential for CAD [coronary artery disease] treatment.”
A press release details that 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 maximise luminal diameter and reduce the risk of restenosis. The system is then fully removed without leaving a permanent metallic implant behind.
Reflow Medical advises that the coronary Spur Elute system is an investigational device only.
