Spirox on Monday released 1-year results from a multi-center study of its Latera absorbable nasal implant, touting a significant reduction in nasal obstruction symptoms in patients with nasal valve collapse.
Results from the study were presented at the 2016 Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery this week.
“Nasal valve collapse has historically been underdiagnosed, as the limited number of options that physicians have to support the Lateral cartilage are generally invasive and have the potential to permanently alter appearance. I am excited that we now have a minimally invasive technology that enables us to effectively and safely support patients’ lateral cartilage and help improve their breathing. Many of my patients felt immediate relief from the implant and no patients had negative cosmetic changes,” principal investigator Dr. Marion San Nicoló said in a press release.
Use of Latera resulted in a significant quality-of-life improvement through 1 year, as rated using the NOSE score, for patients with nasal obstruction and lateral cartilage weakness which resulted in nasal valve collapse.
Patients reported a 53.1% reduction in nasal obstruction symptoms at 1 year, which is in the range of other nasal obstruction treatments, without any negative cosmetic effects, the company said. No failed placement procedures were reported, with 3 post-procedure device retrievals noted in the study.
Risks of use with the device include temporary symptoms such as mild bruising and inflammation, awareness of the implant, mild pain or irritation.
“We are pleased to see a significant reduction in nasal obstruction symptoms maintained at one year. Now that Latera has been proven to effectively support Lateral cartilage in patients with nasal valve collapse, physicians using the technology in the U.S. have told us that they are excited to have a more complete toolkit for the treatment of their nasal obstruction patients,” CMO Dr. Don Gonzales said in a prepared statement.
Spirox won FDA 510(k) clearance for the Latera absorbable nasal implant in July. The company said that the device has already been used in its 1st U.S. cases post-approval.