Reflow Nabs FDA Breakthrough Status for Temporary Spur Stent

Reflow Medical has received breakthrough device designation from the FDA for its retrievable temporary spur stent system, a combination device for treating below-the-knee peripheral artery disease.

The device consists of a retrievable stent system with radially expandable spikes that create multiple pathways for drug delivery.

The temporary spur stent system is intended to address the “treatment challenges” faced by patients with abnormal narrowing of an artery or valve after corrective surgery, the company said.