Reflow Medical’s DEEPER REVEAL Clinical Trial is Underway

Reflow Medical Inc. has completed enrollment in the DEEPER REVEAL clinical trial, which is evaluating the firm’s Reflow Spur Stent. The study enrolled 130 patients in more than 35 U.S. clinical centers.

“We want to thank everyone who has partnered with us in completing this enrollment. Our next step is to gather the necessary follow-up data on our path to U.S. approval,” Reflow Medical Senior Vice President of R&D Teo Jimenez stated. 

Designated a U.S. Food and Drug Administration (FDA) Breakthrough Device, the Spur is a unique clinical solution intended to provide stent-like results while leaving no metal behind. 
 
“The steady rate of enrollment, along with the level of support from so many centers, has been impressive. The response reflects the huge unmet need for treatment options for CLTI,” said S. Jay Mathews, M.D., one of the lead principal investigators and Cath Lab director at Bradenton Cardiology/Manatee Memorial Hospital in Bradenton, Fla. “We’re looking forward to next steps in working with the FDA to bring this technology to our patients.”
 
The prospective, single-arm, multicenter study will examine the efficacy and safety of the Spur Stent for treating vascular lesions in the infrapopliteal arteries below the knee. A device intended for use in patients with critical limb-threatening ischemia (CLTI), this Retrievable Scaffold Therapy (RST) features a retrievable stent with radially self-expanding spikes that treat the diseased vessel wall without leaving anything behind.

“As a physician who has worked with Reflow, I have followed the clinical data generated from the EU trials, which are very promising. I’m looking forward to seeing the final clinical data from the DEEPER REVEAL trial,” said Dr. Mahmood K. Razavi, M.D., one of the study’s lead principal investigators and director of the Clinical Trials and Research Center at St. Joseph Heart & Vascular Center in Orange, Calif.
 
Reflow Medical designs and develops cardiovascular disease technologies. Its portfolio includes products designed for use in treating cardiovascular disease in the coronary arteries, as well as the peripheral vasculature.