Reflow Medical announced that investigators enrolled the first patients in a trial of its Spur sirolimus-eluting retrievable scaffold system.
DEEPER CORONARY evaluates the Spur Elute stent as a primary treatment for in-stent restenosis (ISR) of the coronary arteries. Spur Elute offers a treatment by transferring a proprietary drug formulation to the diseased lesion without leaving a permanent metallic implant behind.
The device’s retrievable scaffold therapy creates channels to increase the uptake of antiproliferative drugs. Meanwhile, it dilates the arterial lumen to maximize gain during the procedure. Doctors then remove the device without leaving anything behind.
San Clemente, California-based Reflow plans for the study to enroll a total of 10 patients at up to three centers in New Zealand. Dr. Scott Harding, an interventional cardiologist at Wellington Hospital in Wellington, New Zealand, serves as principal investigator.
“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,” Harding said in a news release.
Dr. William Lombardi, who attended the first enrollment, noted that anti-proliferative drug delivery while maintaining blood flow, as performed with Spur, constitutes a “crucial element” in treating patients with ISR.
“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. “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).
