Reflow Medical has announced completion of enrolment in the DEEPER REVEAL clinical trial to evaluate the Reflow Spur stent.
The company notes in a press release that the Spur—designated a Breakthrough Device by the US Food and Drug Administration (FDA)—is a unique clinical solution intended to provide stent-like results while leaving no metal behind. The study enrolled 130 patients in over 35 clinical centres in the USA.
“The steady rate of enrolment, along with the level of support from so many centres, has been impressive. The response reflects the huge unmet need for treatment options for CLTI [chronic limb-threatening ischaemia],” said S Jay Mathews (Bradenton Cardiology/Manatee Memorial Hospital, Bradenton, USA), one of the lead principal investigators (PIs). He continued: “We’re looking forward to next steps in working with the FDA to bring this technology to our patients.”
Mahmood K Razavi (St Joseph Heart & Vascular Center, Orange, USA), one of the lead PIs, commented: “As a physician who has worked with Reflow, I have followed the clinical data generated from the EU trials, which are very promising. I’m looking forward to seeing the final clinical data from the DEEPER REVEAL trial.”
The prospective, single-arm, multicentre study will examine the efficacy and safety of the Spur stent for the treatment of vascular lesions in the infrapopliteal arteries below the knee. A novel device intended for use in patients with CLTI, this retrievable scaffold therapy (RST) features a retrievable stent with radially self-expanding spikes that treat the diseased vessel wall without leaving anything behind.
