2 November 2022 - - The first patient was successfully treated and enrolled in the DEEPER REVEAL investigational device exemption clinical trial (NCT05358353) at Advanced Cardiac and Vascular Centers in Grand Rapids, Michigan, US-based medical device company Reflow Medical, Inc said.

The Bare Temporary Spur Stent System was granted Breakthrough Designation status by the US Food and Drug Administration in August 2021.

The DEEPER REVEAL trial is a prospective, single-arm, multicenter study that will examine the efficacy and safety of the Spur Stent for the treatment of vascular lesions in patients with critical limb ischemia.

The device is a temporary self-expanding stent scaffold with radial spikes used to treat the diseased vessel wall without leaving anything behind. It is expected that 130 patients will be enrolled in the study at up to 50 centers.

The study is also being led by co-Principal Investigator Jay Mathews, MD, MS, FACC, FSCAI, of Bradenton Cardiology Center in Bradenton, Florida, and Mahmood K. Razavi, MD, MS, FSIR, FSVM, of Vascular and Interventional Specialists of Orange County, Inc. in Orange, California.

The DEEPER REVEAL trial continues to build on Reflow Medical's commitment to improving outcomes for patients suffering from critical limb ischemia, for which there are limited solutions to date.

Reflow Medical 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 both the coronary and peripheral vasculature.