Reflow Spur’s DEEPER REVEAL Trial Completes Enrollment

May 8, 2024—Reflow Medical, Inc. announced the completion of enrollment in the DEEPER REVEAL clinical trial of the Reflow Spur.

According to the company, the prospective, single-arm, multicenter DEEPER REVEAL study will evaluate the efficacy and safety of the Spur for the treatment of vascular lesions in the infrapopliteal arteries below the knee. The study enrolled 130 patients at more than 35 clinical centers in the United States.

Intended for use in patients with critical limb-threatening ischemia (CLTI), Spur “Retrievable Scaffold Therapy” features a retrievable scaffold with radially self-expanding spikes that treat the diseased vessel wall without leaving anything behind, stated the company.

S. Jay Mathews, MD, and Mahmood K. Razavi, MD, two of the lead Principal Investigators, commented on the progress of the REVEAL DEEPER trial in Reflow Medical’s press release.

“The steady rate of enrollment, along with the level of support from so many centers, has been impressive,” stated Dr. Mathews. “The response reflects the huge unmet need for treatment options for CLTI. We’re looking forward to next steps in working with the FDA to bring this technology to our patients.”

Dr. Razavi added, “As a physician who has worked with Reflow, I have followed the clinical data generated from the European Union trials, which are very promising. I’m looking forward to seeing the final clinical data from the DEEPER REVEAL trial.”

Dr. Mathews is Catheterization Lab Director at Bradenton Cardiology Center/Manatee Memorial Hospital in Bradenton, Florida. Dr. Razavi is the Director of the Clinical Trials and Research Center at St. Joseph Heart & Vascular Center in Orange, California.

In October 2022, the company announced the commencement of enrollment in the trial. The FDA granted Breakthrough Device designation in January 2020.