Reflow Medical Launches Pilot Study for Sirolimus-Eluting Coronary Support System (Spur Elute)

Wednesday, July 03, 2024

Reflow Medical, a developer specializing in cardiovascular devices, has commenced enrollment for a pilot study named "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, a common issue in clinical settings, often leads to significant medical costs and increased risks of rehospitalization and mortality.

The study aims to evaluate the efficacy of their Coronary Sirolimus-Eluting Retrievable Scaffold System, known as "Spur Elute," for treating coronary ISR. This system delivers a proprietary sirolimus drug formulation to diseased lesions without leaving a permanent metal implant.

Scott Harding, the lead researcher and an interventional cardiologist at Wellington Hospital in New Zealand, expressed excitement about the potential of Spur Elute in effectively treating patients with stent restenosis.

The study plans to recruit 10 patients across up to three centers in New Zealand.

Interventional cardiologists at UW Medicine Heart Institute in Seattle, emphasized the importance of delivering antiproliferative drugs while maintaining blood flow, a critical aspect of ISR treatment.

Director of the institute’s complex coronary program, highlighted the significance of such advancements in clinical practice.

The Spur Elute utilizes retrievable scaffold therapy (RST) to enhance drug absorption and dilate arterial lumens during procedures, with the system then removed post-treatment.

The company's commitment to advancing cardiovascular care through the Spur platform. He acknowledged the efforts of their team and external CRO, Mobius Medical, in achieving this milestone.

Reflow Medical recently launched the Reflow coraCatheters™ family, aimed at complex percutaneous coronary interventions (PCI), further expanding their offerings in cardiovascular interventions.






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