FDA grants De Novo Clearance for Reflow Medical's spur stent system

Reflow Medical stent system receives FDA De Novo Clearance: ©Reflow Medical

Reflow Medical Inc. announced Thursday that it has received De Novo clearance from the U.S. Food and Drug Administration for its Spur Peripheral Retrievable Stent System, a first-of-its-kind device for treating patients with below-the-knee (BTK) chronic limb-threatening ischemia (CLTI).

The Spur Stent System is the first retrievable stent featuring a self-expanding scaffold with integrated balloon dilation, designed to improve lesion penetration and vessel compliance during endovascular treatment. The device uses a series of radially expandable spikes—what Reflow calls Retrievable Scaffold Therapy (RST)—to increase the artery's diameter and reduce the chance of vessel recoil.

“Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur Stent System,” said Dr. Mahmood K. Razavi, Director of the Clinical Trials and Research Center at St. Joseph Heart and Vascular Center in Orange, California. “This novel device will be a valuable and innovative expansion of our treatment toolbox.”

The DEEPER REVEAL trial, a multi-center study conducted at 49 sites across the U.S., showed a 99.2% technical success rate and 97.0% freedom from major adverse limb events (MALE) and perioperative death (POD) at 30 days. The study enrolled 130 patients with complex BTK lesions.

Reflow Medical plans a full commercial launch of the system. “We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients,” said Isa Rizk, CEO and Co-Founder of Reflow Medical.