Reflow’s Pilot Study of Spur Elute Scaffold for ISR Completes Enrollment

September 29, 2025—Reflow Medical, Inc. announced the completion of enrollment in DEEPER CORONARY, a pilot study evaluating the company’s Spur Elute coronary sirolimus-eluting retrievable scaffold system as a primary treatment for in-stent restenosis (ISR) of the coronary arteries.

The first-in-human study enrolled nine patients, who will be followed for 1 year after the procedure, noted the press release.

According to the company, Spur Elute features radially expandable spikes and an integrated balloon, both of which are drug coated. It is designed to treat patients with coronary ISR by dilating and delivering the company’s sirolimus drug formulation.

Using retrievable scaffold therapy, the Spur Elute spikes create channels to increase uptake of the antiproliferative drug into the vessel wall, while dilating the arterial lumen to maximize luminal gain and reduce restenosis. The system is then fully removed without leaving a permanent metallic implant behind, stated Reflow Medical.

The Principal Investigator of the DEEPER CORONARY trial is Scott Harding, MD, who is Director of the Cardiology Research Group at Wellington Hospital in Wellington, New Zealand.

“The preliminary results of the trial are encouraging, highlighting the potential of Spur Elute to address the challenges of ISR,” commented Dr. Harding in the company’s press release. “It is designed to reduce neointimal hyperplasia and recoil of the hyperplastic neointima without leaving another stent behind.”

Reflow Medical advised that Dr. Harding will present late-breaking data from DEEPER CORONARY at TCT 2025 in the Innovation category. Highlights will include the primary endpoint, treatment of the target lesion with the investigational device without the occurrence of in-hospital major adverse cardiac events (defined as all-cause death, myocardial infarction, and any clinically driven target lesion revascularization), as well as secondary endpoints of lesion success and safety data through 30 days.