Spirair Inc. won the race for the first U.S. FDA 510(k) clearance for a minimally invasive therapy for nasal septal deviation (NSD), the company said. The Septalign system features a bioabsorbable implant that enables minor cartilaginous septal deviation that can be placed in an office with local anesthesia.
“Traditional septoplasty and septorhinoplasty can require significant time away from work, with nearly 42% of patients requiring two weeks or more for recovery. With Septalign, recovery is much faster and requires little to no time away from work for recovery,” Spirair CEO Ben Bishop told BioWorld.