The first patients have been enrolled in the single-centre DEEPER LIMUS clinical trial, Reflow Medical has announced. The non-randomised 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 enrol up to 30 patients for approximately six months at a single centre outside the USA. It will follow primary and secondary endpoints for safety and efficacy.
“This gives us an opportunity to truly understand how differently antirestenotic drugs can treat infrapopliteal disease,” the trial’s principal investigator Marianne Brodmann (Medical University of Graz, Graz, Austria) comments. “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 minimising 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, state Reflow Medical.