SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc. announces that it has completed patient enrollment in the DEEPER OUS clinical trial (NCT03807531) for the company’s Temporary Spur Stent System, a novel device that features a retrievable stent designed for complex infrapopliteal disease.
106 patients have now been enrolled in the prospective, nonrandomized trial in multiple centers in Europe and New Zealand. Intended for use in conjunction with a commercially available drug-coated balloon (DCB), the Temporary Spur Stent features a self-expanding nitinol scaffold with radially expanding spikes designed to penetrate the diseased vessel wall and enhance drug delivery, without leaving anything behind.
According to Michael Lichtenberg, MD, FESC, Chief Medical Officer of the Angiology Department at Vascular Centre Clinic, Arnsberg, Germany, and a Principal Investigator for the trial, “The temporary mechanical scaffolding, followed by a DCB, has the potential to minimize vessel recoil and boost luminal gain.” He continues, “The fact that it does so without leaving anything behind means the patient avoids the risk of complications from the use of a stent.”
“Completing enrollment is a significant milestone in the clinical validation and regulatory pathway to approval of the Spur Stent System to treat patients,” said Teo Jimenez, Vice President of Research and Development for Reflow Medical.
Isa Rizk, CEO and Co-Founder of Reflow Medical, continues, “We are setting a new standard in the design and engineering of effective technology used to treat complex cardiovascular disease including critical limb ischemia. Our comprehensive portfolio of support catheters, microcatheters, CTO devices, and future therapeutic devices (Spur) helps expand our mission.”
Andrew Holden, MD, Director of Interventional Radiology at Auckland City Hospital and Professor of Radiology at the University of Auckland, is also one of the Principal Investigators for the Temporary Spur Stent System trial. “This is truly a novel approach to treatment and the clinical results have been excellent to date.”
About Reflow Medical, Inc.
Reflow Medical, Inc. focuses on empowering physicians through the design and development of innovative and effective technologies for cardiovascular disease. The Reflow product portfolio includes products used to treat cardiovascular disease in the peripheral vasculature as well as the coronary arteries.