Reflow Medical has enrolled the first patient for a pilot study to assess the Coronary Sirolimus-Eluting Retrievable Scaffold System, known as Spur Elute.
The Spur Elute medical device is designed to address in-stent restenosis (ISR) in coronary arteries, a condition that can lead to increased mortality and hospital readmissions.
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Titled ‘Drug-eluting coronary spur stent as a primary treatment for in-stent restenosis of the coronary arteries’ (DEEPER CORONARY), the study is set to enrol ten subjects across up to three centres in New Zealand.
The system’s Retrievable Scaffold Therapy (RST) technology works by creating channels that enhance the uptake of antiproliferative drugs and dilate the arterial lumen for optimal procedural gain, after which the device is removed.
Wellington Hospital in New Zealand interventional cardiologist Scott Harding is the principal investigator of the study.
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.”
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By GlobalDataReflow 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 follows Reflow’s introduction of the coraCatheters line last year for complex percutaneous coronary interventions.
Earlier this year, Reflow Medical’s stent system designed to treat de novo or restenotic lesions in the infrapopliteal arteries was awarded a CE mark.
