DEEPER REVEAL Clinical Trial Enrollment Completed by Reflow Medical

10 May 2024

Reflow Medical, a pioneer in cardiovascular disease device development, has successfully wrapped up patient enrollment in the DEEPER REVEAL clinical trial (NCT05358353) assessing the Reflow Spur™ Stent.

Acknowledged as a Breakthrough Device by the FDA, the Spur offers a novel clinical solution aiming for stent-like outcomes while avoiding residual metal. Over 130 patients were enrolled across more than 35 clinical centers in the United States.

MD, MS, FACC, FSCAI, serving as one of the Lead Principal Investigators and Cath Lab Director at Bradenton Cardiology/Manatee Memorial Hospital in Bradenton, Florida, noted the significant response from clinical centers, indicating a substantial need for treatment options for CLTI.

Anticipation for collaboration with the FDA to make this technology accessible to patients.

PI and Director of the Clinical Trials and Research Center at St. Joseph Heart & Vascular Center in Orange, California, expressed eagerness to review the final clinical findings from the DEEPER REVEAL trial, citing promising data from EU trials.

The DEEPER REVEAL trial, a prospective, single-arm, multicenter study, aims to evaluate the efficacy and safety of the Spur Stent in treating vascular lesions in the infrapopliteal arteries below the knee.

Developed as a unique device for patients with critical limb-threatening ischemia (CLTI), this Retrievable Scaffold Therapy (RST) integrates a retrievable stent with radially self-expanding spikes targeting the diseased vessel wall without residual elements.

Expressed gratitude for completing enrollment in the DEEPER REVEAL study and highlighted the next steps in collecting follow-up data towards U.S. approval.