Reflow Medical’s Bare Temporary Spur Stent System’s DEEPER REVEAL IDE Clinical Study Begins Enrollment

October 31, 2022—Reflow Medical, Inc. announced that the first patient was successfully treated and enrolled in the DEEPER REVEAL investigational device exemption (IDE) clinical trial, which is evaluating the company’s bare Temporary Spur stent system.

The device is a temporary self-expanding stent scaffold with radial spikes used to treat the diseased vessel wall without leaving anything behind. The bare Temporary Spur was granted an FDA Breakthrough Device designation in August 2021.

According to the company, 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 (CLI). It is expected that 130 patients will be enrolled in the study at up to 50 centers. 

Jihad A. Mustapha, MD, who is President & Chief Executive Officer and Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers, in Grand Rapids, Michigan, serves as one of the coprincipal investigators for the study. 

“The Spur stent was created to fulfill an unmet need in treating patients with CLI,” commented Dr. Mustapha in the company’s press release. “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.”

The study is also being led by coprincipal investigators Jay Mathews, MD, and Mahmood K. Razavi, MD.

Dr. Mathews, who is from Bradenton Cardiology Center in Bradenton, Florida, stated in the press release, “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.”

Dr. Razavi added, “This is a pioneering technology that has already shown promising results in previous trials treating below-the-knee disease. 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.” Dr. Razavi is from Vascular and Interventional Specialists of Orange County, Inc. in Orange, California.

Finally, Isa Rizk, CEO and Cofounder of Reflow Medical, advised, “This is a major step on the path to United States approval for the Spur stent. 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.”