Spur® Elute DEEPER CORONARY Study Completes Enrollment

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Reflow Medical, Inc., a leading developer of innovative devices for treating complex cardiovascular disease, announces the completion of enrollment in the DEEPER CORONARY study. This pilot study evaluates the Spur^® Elute Coronary Sirolimus-Eluting Retrievable Scaffold System as a primary treatment for in-stent restenosis (ISR) of the coronary arteries (NCT06117150).

Spur Elute is the first and only retrievable self-expanding scaffold with radially expandable spikes, combined with an integrated balloon, both of which are drug coated. It is designed to treat patients with coronary ISR by dilating and delivering a sirolimus drug formulation unique to Reflow Medical.

“ISR is an inherent risk of permanent stent implantation, leading to substantial healthcare costs, and is often associated with increased risks of death and rehospitalization,” said William Lombardi, MD, Interventional Cardiologist and Director of the Complex Coronary Program at UW Medicine Heart Institute in Seattle, Washington and a member of the Reflow Medical scientific advisory board. “It is great to collaborate with a company committed to addressing coronary challenges with innovations such as the Spur Elute.”

The DEEPER CORONARY first-in-human study successfully completed enrollment with nine subjects treated. Participants will continue follow up for one year after the procedure.

Known as Retrievable Scaffold Therapy (RST), 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.

Scott Harding, MD, Director of the Cardiology Research Group at Wellington Hospital, Wellington, New Zealand, and principal investigator of the DEEPER CORONARY trial, commented, “The preliminary results of the trial are encouraging, highlighting the potential of Spur Elute to address the challenges of ISR. It is designed to reduce neointimal hyperplasia and recoil of the hyperplastic neointima without leaving another stent behind.”

Isa Rizk, CEO and Co-Founder of Reflow Medical, Inc., added, “The completion of enrollment in the DEEPER CORONARY study is an important milestone for patients suffering from coronary in-stent restenosis, and for the physicians dedicated to treating this challenging condition. We are proud of our team and partners for making this possible and look forward to sharing the first clinical results at TCT 2025.”

Late-breaking data from DEEPER CORONARY will be presented by Dr. Harding at the Cardiovascular Research Foundation’s 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 MACE (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.

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 a revolutionary device enabling Retrievable Scaffold Therapy (RST). The coronary CoraCatheters 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.