Reflow Medical Enrolls First Patients in Pilot Study of Coronary Sirolimus-Eluting Retrievable Scaffold System (Spur Elute)

Reflow Medical, Inc., a developer of innovative devices focused on cardiovascular disease, announces the first patient enrollments in "A pilot study of the Drug-Eluting Coronary Spurtm StEnt as a Primary trEatment for in-stent Restenosis (ISR) of the CORONARY arteries" (DEEPER CORONARY, NCT06117150). ISR is a common clinical problem that can generate significant health care costs and is often associated with an increased risk of death and rehospitalization. Known as the Coronary Sirolimus-Eluting Retrievable Scaffold System, or "Spur Elute," this unique clinical solution is intended to treat patients with coronary ISR by transferring a proprietary sirolimus drug formulation to the diseased lesion without leaving a permanent metallic implant behind. The study is approved to enroll a total of 10 patients at up to three centers in New Zealand.

Principal Investigator Prof. Scott Harding, M.D., is an interventional cardiologist specializing in the treatment of complex coronary disease at Wellington Hospital in Wellington, New Zealand. He shared his experience with the Spur Elute, saying, "It's exciting to take part in the study of this novel platform, which has the potential to successfully treat patients suffering from in-stent restenosis."

William Lombardi, M.D., and Kathleen E. Kearney, M.D., interventional cardiologists at the UW Medicine Heart Institute in Seattle, Washington, were in attendance at the first enrollment. "Being able to deliver anti-proliferative drugs while maintaining blood flow can be a crucial element for treating ISR patients," said Dr. Lombardi, who is the Director of the Complex Coronary Program at the Institute.

The Spur Elute is a novel device whose Retrievable Scaffold Therapy (RST) creates channels to increase uptake of antiproliferative drugs, while dilating the arterial lumen to maximize gain during the procedure. The system is then removed, without leaving anything behind.

"These enrollments take us one step closer to enabling physicians to utilize the Spur platform for treating patients with cardiovascular disease, and ISR in particular," said Isa Rizk, CEO and Co-Founder of Reflow Medical, Inc. "We are so proud of the entire team and grateful to our external CRO, Mobius Medical, for reaching this milestone." The pilot study of the Spur Elute for accessing and treating ISR follows last year's successful introduction of the Reflow coraCatheterstm line for complex percutaneous coronary interventions (PCI).

About Reflow Medical, Inc.

Reflow Medical, Inc. focuses on empowering physicians through the design and development of innovative and effective technologies for cardiovascular disease. The Reflow portfolio includes products designed for use in treating cardiovascular disease in the coronary and peripheral vasculature.