June 10, 2020
Enrollment Begins in DEEPER LIMUS Study of Reflow Medical’s Temporary Spur Stent System
June 10, 2020—Reflow Medical, Inc. announced enrollment of the first patients in the single-center DEEPER LIMUS clinical trial. The nonrandomized pilot study will evaluate the Temporary Spur stent system for the treatment of lesions in the infrapopliteal arteries using a limus-base drug-coated balloon.
According to the company, the DEEPER LIMUS study is expected to enroll up to 30 patients for approximately 6 months at a single center outside the United States. It will follow primary and secondary endpoints for safety and efficacy. The trial’s principal investigator is Professor Marianne Brodmann, MD, from the Medical University of Graz in Graz, Austria.
“This gives us an opportunity to truly understand how differently antirestenotic drugs can treat infrapopliteal disease,” commented Prof. Brodmann in Reflow Medical's announcement. “The unique design of the Spur device may enable the antiproliferative drug to reach the medial layers of the arterial wall, without leaving anything behind, and minimizing the need for follow-up procedures.”
The retrievable Temporary Spur stent system is designed to treat long, diffuse, and severely calcified infrapopliteal disease. The device has a series of radially expandable spikes intended to create multiple pathways to allow the increased uptake of antiproliferative drugs into the vessel wall and facilitate acute luminal gain, without leaving anything behind, stated Reflow Medical.