Update Presented on Trial of Reflow’s Temporary Spur Stent System for BTK Treatment
November 5, 2019—VIVA Physicians announced that Professor Thomas Zeller, MD, provided an update on the DEEPER OUS study in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
As noted in the VIVA summary of the presentation, the purpose of the DEEPER OUS study is to evaluate the safety and efficacy of the Temporary Spur stent system (Reflow Medical, Inc.) in conjunction with a commercially available drug-coated balloon. Additionally, an angiographic substudy examining recoil will be conducted on the first 10 patients from each site.
Prof. Zeller reported that enrollment in the prospective, multicenter, nonrandomized, single-arm study began in July 2019 and is anticipated to be completed in 2020. The study will be composed of 100 patients in New Zealand, Germany, and Switzerland. He noted acute technical and procedural success for patients enrolled through October 2018 and presented ultrasound and clinical data from the first enrolled patients. Examination of patency rates and long-term safety data is ongoing.