Reflow’s Bare Temporary Spur Receives CE Mark Approval to Treat BTK Lesions

January 15, 2024—Reflow Medical, Inc. announced it has received CE Mark certification in the European Union for the Bare Temporary Spur system. The device is intended to treat de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coated balloon (DCB) to enhance drug absorption.

“The device performance and clinical study data for patients suffering from chronic limb-threatening ischemia has been quite impressive,” commented Professor Thomas Zeller, MD, in the company’s press release. Prof. Zeller, who served as a Principal Investigator in the DEEPER OUS clinical trial, is Chief of the Department of Angiology at University Heart Center Freiburg in Bad Krozingen, Germany.

Marianne Brodmann, MD, added, “We have found that the Spur allows us to treat patients with below-the-knee disease using stent therapy, without the long-term risk of a stent implant.” Prof. Brodmannn, Principal Investigator for the DEEPER LIMUS clinical trial, is Chief of the Department of Angiology at University Heart Center Freiburg in Bad Krozingen, Germany. The DEEPER LIMUS clinical trial evaluated the Bare Temporary Spur system.

In October 2023, Prof. Zeller presented 1-year results from DEEPER OUS at VIVA23, the Vascular InterVentional Advances annual vascular education symposium. The DEEPER OUS trial evaluated the safety and efficacy of the Bare Temporary Spur system used in conjunction with a commercially available DCB to treat patients with symptomatic infrapopliteal arterial disease. The trial was conducted in New Zealand, Germany, and Switzerland.

According to the company, treatment with the Reflow Bare Temporary Spur system, followed by DCB treatment, has been shown to reduce clinically driven target lesion revascularization, improve wound healing, reduce recoil, and improve vessel patency through 1 year compared to historical treatment outcomes with plain balloon angioplasty or a DCB alone.

Reflow Medical further stated that the Bare Temporary Spur system is intended to provide stent-like results while leaving no metal behind. Known as retrievable scaffold therapy, or RST, the device is designed with radial spikes for creating channels in the vessel wall to enhance drug absorption and reduce recoil. The device is then recaptured and removed. The vessel is then treated with a commercially available DCB.