Reflow Medical’s Bare Temporary Stent System Studied in DEEPER OUS Trial

June 12, 2023—Reflow Medical, Inc. announced 6-month results from the DEEPER OUS clinical trial evaluating the safety and efficacy of the company’s bare Temporary Spur stent system for the treatment of infrapopliteal artery disease. Follow-up to 5 years is ongoing, noted the company.

Reflow Medical’s bare Temporary Spur stent system is designed to deliver a temporary stent with integrated radial spikes to the peripheral vasculature via a sheathed delivery system, for stent-like results while leaving nothing behind. The device is available for investigational use only.

The findings were presented at LINC, the Leipzig Interventional Course, held June 6-9 in Leipzig, Germany.

At LINC, Michael Lichtenberg, MD, reported that the study of the bare Temporary Spur stent system used in conjunction with a commercially available paclitaxel-coated balloon met the primary effectiveness endpoint with an 86% primary patency rate at 6 months. Additionally, the primary safety endpoint of freedom from target limb major adverse limb events and all-cause perioperative death at 30 days was met in 100% of patients. Dr. Lichtenberg is Chief Medical Officer and Director of the Angiology and Vascular Center in Arnsberg, Germany.

Also at LINC, findings from a substudy evaluating acute vessel recoil were presented by Professor Thomas Zeller, MD, who is Chief of the Department of Angiology at University Heart Center Freiburg in Bad Krozingen, Germany.

The substudy of 38 patients (40 lesions) treated with the bare Temporary Spur stent system demonstrated a > 50% reduction in vessel recoil: 42.5% with Reflow’s Temporary Spur versus 97% in previously reported rates with percutaneous transluminal angioplasty. Additionally, there was a trend toward improved 6-month patency in patients without vessel recoil.

“It’s gratifying to see the improvement in our patients 6 months after treatment with the Spur stent system,” commented Dr. Lichtenberg in Reflow Medical’s press release. “We observed improvements in their Rutherford class scores, and fewer than 8% required revascularization during the 6-month period.”

Prof. Zeller stated that the substudy results showed that “calcification did not appear to have an effect on vessel patency or vessel recoil, suggesting that the bare Temporary Spur stent system may modify calcification, decrease recoil, and enhance drug uptake.”