Reflow Medical has announced the first patient enrolments in DEEPER CORONARY, a pilot study of its drug-eluting coronary spur stent as a treatment for in-stent restenosis of the coronary arteries.
The device, known as Spur Elute, is intended to treat patients with coronary ISR by transferring a proprietary sirolimus drug formulation to the diseased lesion without leaving a permanent metallic implant behind. The study is approved to enrol a total of 10 patients at up to three centres in New Zealand.
Principal investigator, Scott Harding, is an interventional cardiologist specialising in the treatment of complex coronary disease at Wellington Hospital in Wellington, New Zealand. He 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.”
William Lombardi and Kathleen E Kearney, interventional cardiologists at the UW Medicine Heart Institute in Seattle, USA, were in attendance at the first enrolment. “Being able to deliver anti-proliferative drugs while maintaining blood flow can be a crucial element for treating ISR patients,” said Lombardi.
The Spur Elute is a novel device whose retrievable scaffold therapy (RST) creates channels to increase uptake of antiproliferative drugs, while dilating the arterial lumen to maximise gain during the procedure. The system is then removed, without leaving anything behind.
“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,” 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).
