Reflow Medical Enrolls First Patients in Pilot Study of Spur Elute System

Reflow Medical, Inc., based in San Clemente, California, has initiated the enrollment of the first participants in a groundbreaking pilot study titled "A pilot study of the Drug-Eluting Coronary Spur™ StEnt as a Primary trEatment for in-stent Restenosis (ISR) of the CORONARY arteries” (DEEPER CORONARY, NCT06117150). ISR is a frequent clinical issue that incurs substantial healthcare costs and is linked to a higher risk of mortality and readmission to the hospital. The innovative solution at the center of this study is the Coronary Sirolimus-Eluting Retrievable Scaffold System, also known as “Spur Elute.” This device aims to treat patients suffering from coronary ISR by delivering a proprietary sirolimus drug formulation directly to the affected lesion, without the need for a permanent metallic implant.

The study has received approval to enroll a total of ten patients across up to three centers in New Zealand.

Prof. Scott Harding, M.D., an interventional cardiologist at Wellington Hospital in Wellington, New Zealand, is the Principal Investigator for this study. With a specialization in the treatment of complex coronary diseases, Prof. Harding expressed his enthusiasm for participating in this novel study. He highlighted the potential of the Spur Elute platform to effectively treat patients experiencing ISR.

The first patient enrollment also saw the presence of Dr. William Lombardi and Dr. Kathleen E. Kearney, interventional cardiologists at the UW Medicine Heart Institute in Seattle, Washington. Dr. Lombardi, who serves as the Director of the Complex Coronary Program at the Institute, emphasized the importance of delivering anti-proliferative drugs while maintaining blood flow for ISR patients.

The Spur Elute device features a Retrievable Scaffold Therapy (RST) that creates channels to enhance the uptake of antiproliferative drugs, while simultaneously dilating the arterial lumen to maximize procedural success. Importantly, the system is designed to be removed after the procedure, leaving no permanent elements behind.

Isa Rizk, CEO, and Co-Founder of Reflow Medical, Inc., stated that the recent enrollments mark significant progress toward enabling physicians to utilize the Spur platform for treating cardiovascular diseases, especially ISR. He acknowledged the contributions of the entire team and the external Contract Research Organization (CRO), Mobius Medical, in achieving this milestone. This pilot study follows the successful introduction last year of the Reflow coraCatheters™ line, aimed at complex percutaneous coronary interventions (PCI).

Reflow Medical, Inc. is dedicated to empowering physicians by designing and developing innovative technologies targeted at cardiovascular diseases. Their product portfolio encompasses solutions for treating cardiovascular conditions in both coronary and peripheral vasculature.