Reflow Medical Begins DEEPER CORONARY Pilot Study

Reflow Medical announced it has enrolled the first patients in “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).

Reflow’s coronary Sirolimus-eluting retrievable scaffold system (Spur Elite) treats coronary ISR by delivering a proprietary sirolimus drug formation to the diseased lesion without leaving behind an implant. Spur Elute’s retrievable scaffold therapy (RST) creates channels to boost the uptake of antiproliferative drugs while dilating the arterial lumen to maximize gain.

The DEEPER CORONARY study was approved to enroll 10 patients at three centers in New Zealand.

“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. “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 coraCatheters line for complex percutaneous coronary interventions (PCI).

Last month, the company finished enrollment in its DEEPER REVEAL clinical trial, which will examine the efficacy and safety of the Spur stent for treating vascular lesions in the infrapopliteal arteries below the knee.