Reflow Medical, Inc., a California-based medical device company, has enrolled the first patients in A Non-RanDomized Pilot Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base Drug-coated Balloon (DEEPER LIMUS).
Reflow Medical notes the OUS single-center clinical trial (NCT04162418) is expected to enroll up to 30 participants and last approximately six months. It will follow primary and secondary endpoints for safety and efficacy.
The Temporary Spur Stent System is a novel retrievable stent designed to treat long, diffuse and severely calcified infrapopliteal disease. The device consists of a patented retrievable stent system having a series of radially expandable spikes designed to create multiple pathways to allow the increased uptake of antiproliferative drugs (“limus” based) into the vessel wall and facilitate acute luminal gain, without leaving anything behind. The device was developed in response to unmet clinical needs in treating patients suffering from critical limb ischemia (CLI), a serious condition in below-the-knee (BTK) disease that can result in high rates of restenosis and further treatment challenges.
Marianne Brodmann, MD, a professor and vascular specialist at the Medical University of Graz, Austria, is the trial’s principal investigator. “This gives us an opportunity to truly understand how differently anti-restenotic drugs can treat infrapopliteal disease,” she commented. “The unique design of the Spur device may enable the anti-proliferative drug to reach the medial layers of the arterial wall, without leaving anything behind, and minimizing the need for follow-up procedures.”
Company Co-founder and CEO Isa Rizk noted, “We are excited to gather data to support the clinical use of the Spur Stent in conjunction with a limus-coated balloon. This new study data will be added to a portfolio of other studies completed or currently enrolling on this groundbreaking medical technology.”