Reflow Medical has enrolled the first patient in a pilot trial of the Coronary Sirolimus-Eluting Retrievable Scaffold System (Spur Elute) on patients with coronary in-stent restenosis (ISR).
The study, known as DEEPER CORONARY, will recruit 10 patients at up to three centres in New Zealand.
New Zealand’s Wellington Hospital interventional cardiologist and trial principal investigator Scott Harding said: “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.”
Spur Elute addresses coronary ISR in patients by delivering a proprietary sirolimus drug formulation directly to the affected lesion without the use of a permanent metallic implant.
The solution uses retrievable scaffold therapy (RST) to create channels that enhance the absorption of antiproliferative drugs.
It simultaneously dilates the arterial lumen to optimise procedural outcomes. After use, the system is completely removed, leaving no residual components behind.
Reflow Medical CEO and co-founder Isa Rizk said: “These enrolments take us one step closer to enabling physicians to utilise the Spur platform for treating patients with cardiovascular disease, and ISR in particular.
“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 the successful introduction last year of the Reflow coraCatheters line for complex percutaneous coronary interventions (PCI).
In May this year, Reflow Medical completed the patient enrolment in the DEEPER REVEAL clinical trial to assess the Reflow Spur Stent.
The US Food and Drug Administration (FDA) has designated the Reflow Spur Stent as a Breakthrough Device, which provides stent-like results while leaving no metal behind.
