Reflow Medical Commences DEEPER CORONARY Pilot Study of Spur Elute Retrievable Scaffold

July 1, 2024—Reflow Medical, Inc. announced that the first patients were enrolled in DEEPER CORONARY, a pilot study of the company’s Spur Elute sirolimus-eluting retrievable scaffold system as a primary treatment for in-stent restenosis (ISR) of the coronary arteries.

Reflow Medical stated that the study is approved to enroll 10 patients at up to three centers in New Zealand. The study’s Principal Investigator is Professor Scott Harding, MD, an interventional cardiologist at Wellington Hospital in Wellington, New Zealand.

According to the company, the Spur Elute incorporates the company’s Retrievable Scaffold Therapy, which creates channels to increase uptake of antiproliferative drugs while dilating the arterial lumen to maximize gain during the procedure. The system is then removed without leaving anything behind.

Enrollment of the first patient was attended by William Lombardi, MD, and Kathleen E. Kearney, MD, interventional cardiologists at the University of Washington’s UW Medicine Heart Institute in Seattle, Washington. Dr. Lombardi is the Director of the Complex Coronary Program at the institute.

“It’s exciting to take part in the study of this novel platform, which has the potential to successfully treat patients suffering from ISR,” commented Prof. Harding in Reflow Medical’s press release.

Dr. Lombardi added, “Being able to deliver antiproliferative drugs while maintaining blood flow can be a crucial element for treating ISR patients.”

The company noted that this pilot study of Spur Elute for accessing and treating ISR comes after the launch of Reflow Medical’s CoraCatheters line of microcatheters designed to access and cross complex and challenging lesions in percutaneous coronary intervention, announced in May 2023.