Positive Clinical Study Results for Nasal Valve Collapse Implant

The 2016 Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery has seen nasal obstruction specialist company, Spirox™, Inc., announcing positive results from a prospective, multi-center study of the LATERA™ Absorbable Nasal Implant.

Background

Nasal airway obstruction can be caused by several factors, including septal deviation, enlarged turbinates, and weakened upper and/or lower lateral nasal wall cartilage leading to nasal valve collapse, an important, but often overlooked, cause of nasal obstruction. The nasal valve contributes as much as 80 percent of total nasal airway resistance3, and even minor constriction of this area results in a clinically significant impairment of nasal breathing for the patient.

LATERA is an absorbable polymer implant indicated for supporting the upper and lower lateral nasal cartilage. The minimally invasive technology is intuitive and can be delivered by otolaryngologists (ENTs) or plastic surgeons.

The newly presented study included 30 patients with nasal valve collapse as a primary or significant contributor to their nasal airway obstruction symptoms and all LATERA implants were placed in stand-alone procedures. Patients were enrolled at three centers in Germany, the University of Munich, the Technical University of Munich, and Klinikum Mannheim. Prof. Dr. med. Alexander Berghaus and Dr. med. Marion San Nicoló of the University of Munich are the principal investigators for this study.

Results showed that the Latera device provides a significant reduction in nasal obstruction symptoms in patients with the condition, and that early improvements were maintained through one year. Patients experienced significant quality-of-life improvement through one year, using the NOSE score, for nasal obstruction patients with lateral cartilage weakness resulting in nasal valve collapse. Improvements included less nasal blockage or obstruction, less trouble breathing through the nose while at rest or during exercise, and less trouble sleeping. Patients experienced a reduction in nasal obstruction symptoms of 53.1 percent at one year—in the range of other nasal obstruction treatments—without negative cosmetic effects. All procedures resulted in successful acute implant placement to the target locations and three post-procedure device retrievals were reported. Risks included temporary symptoms such as mild bruising and inflammation, awareness of the implant, and mild pain or irritation. Other risks related to the LATERA implant included discomfort, infection and reaction to material.

The results were selected for presentation as one of the 10 “Best of Orals” sessions, out of 700 submissions, at the event.

Investigator comments

“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,” said Dr. med. Marion San Nicoló, one of the study’s principal investigators. “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.”

Company comments

“We are pleased to see a significant reduction in nasal obstruction symptoms maintained at one year,” said Spirox Chief Medical Officer Don Gonzales, MD. “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.”

Source: Spirox, Inc.

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