Michael Barbella, Managing Editor01.06.23
The first patient has been successfully treated and enrolled in Reflow Medical Inc.'s DEEPER REVEAL investigational device exemption (IDE) clinical trial. The patient received treatment at Advanced Cardiac & Vascular Centers (ACV) in Grand Rapids, Mich.
“This is a major step on the path to U.S. approval for the Spur Stent," Reflow Medical Co-Founder/CEO Isa Rizk said. "We’re certainly grateful to partner with our principal investigators and looking forward to working with all the future hospitals and institutions as we gain traction and enrollments for continued clinical validation.”
The DEEPER REVEAL trial is a prospective, single-arm, multicenter study that will examine the efficacy and safety of the Bare Temporary Spur Stent System for treating vascular lesions in patients with critical limb ischemia (CLI). 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 System received Breakthrough Designation status by the U.S. Food and Drug Administration (FDA) in August 2021.
“The Spur Stent was created to fulfill an unmet need in treating patients with CLI. The ease with which this device can be directed to the lesion, deployed and retrieved should be acknowledged. We are excited to be studying this breakthrough technology,” said Jihad A. Mustapha, M.D., a study co-principal Investigator and ACV’s president, CEO, and director of Endovascular Interventions.
The study is also being led by co-principal investigators Jay Mathews, M.D., of Bradenton Cardiology Center in Bradenton, Fla., and Mahmood K. Razavi, M.D., of Vascular and Interventional Specialists of Orange County Inc. in Orange, Calif. Mathews said, “The Spur Stent has shown encouraging results to date in trials in Europe, notably in achieving acute luminal gain and reducing vessel recoil. We’re looking forward to enrolling our first patients in the DEEPER REVEAL study here in Florida.”
“This is a pioneering technology that has already shown promising results in previous trials treating below-the-knee disease,” Razavi said. “The Spur Stent technology provides a novel approach for controlled treatment of calcified vessel walls. The fact that it leaves no metal behind will preserve future treatment options.”
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 Inc. designs and develops cardiovascular disease treatment technologies. The Reflow product portfolio includes products used to treat cardiovascular disease in both the coronary and peripheral vasculature.
“This is a major step on the path to U.S. approval for the Spur Stent," Reflow Medical Co-Founder/CEO Isa Rizk said. "We’re certainly grateful to partner with our principal investigators and looking forward to working with all the future hospitals and institutions as we gain traction and enrollments for continued clinical validation.”
The DEEPER REVEAL trial is a prospective, single-arm, multicenter study that will examine the efficacy and safety of the Bare Temporary Spur Stent System for treating vascular lesions in patients with critical limb ischemia (CLI). 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 System received Breakthrough Designation status by the U.S. Food and Drug Administration (FDA) in August 2021.
“The Spur Stent was created to fulfill an unmet need in treating patients with CLI. The ease with which this device can be directed to the lesion, deployed and retrieved should be acknowledged. We are excited to be studying this breakthrough technology,” said Jihad A. Mustapha, M.D., a study co-principal Investigator and ACV’s president, CEO, and director of Endovascular Interventions.
The study is also being led by co-principal investigators Jay Mathews, M.D., of Bradenton Cardiology Center in Bradenton, Fla., and Mahmood K. Razavi, M.D., of Vascular and Interventional Specialists of Orange County Inc. in Orange, Calif. Mathews said, “The Spur Stent has shown encouraging results to date in trials in Europe, notably in achieving acute luminal gain and reducing vessel recoil. We’re looking forward to enrolling our first patients in the DEEPER REVEAL study here in Florida.”
“This is a pioneering technology that has already shown promising results in previous trials treating below-the-knee disease,” Razavi said. “The Spur Stent technology provides a novel approach for controlled treatment of calcified vessel walls. The fact that it leaves no metal behind will preserve future treatment options.”
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 Inc. designs and develops cardiovascular disease treatment technologies. The Reflow product portfolio includes products used to treat cardiovascular disease in both the coronary and peripheral vasculature.