Reflow’s Temporary Spur System Evaluated in DEEPER OUS Trial in Europe and New Zealand

May 10, 2022—Reflow Medical, Inc. announced that it has completed patient enrollment in the DEEPER OUS clinical trial of the company’s Temporary Spur stent system for the treatment of narrowing and blockages in the arteries below the knee.

Reflow stated that the Temporary Spur device features a retrievable stent designed for the treatment of complex infrapopliteal disease. The self-expanding nitinol scaffold with radially expanding spikes is designed to penetrate the diseased vessel wall and enhance drug delivery, without leaving anything behind. It is intended for use in conjunction with a commercially available drug-coated balloon (DCB).

According to the company, the prospective, nonrandomized trial has enrolled 106 patients in multiple centers in Europe and New Zealand.

Michael Lichtenberg, MD, and Andrew Holden, MD, serve as principal investigators of the trial. Dr. Lichtenberg is Chief Medical Officer of the Angiology Department at Vascular Center Clinic in Arnsberg, Germany. Dr. Holden is Director of Interventional Radiology at Auckland City Hospital and Professor of Radiology at the University of Auckland in Auckland, New Zealand.

“The temporary mechanical scaffolding, followed by a DCB, has the potential to minimize vessel recoil and boost luminal gain,” commented Dr. Lichtenberg in the company’s press release. “The fact that it does so without leaving anything behind means the patient avoids the risk of complications from the use of a stent.”

Dr. Holden added, “This is truly a novel approach to treatment and the clinical results have been excellent to date.”