Spirox said today it won FDA 510(k) clearance for its Latera absorbable nasal implant designed to support upper and lower Lateral nasal cartilages to prevent nasal valve constriction or collapse.
The Menlo Park, Calif-based company said that the device has already been used in its 1st U.S. cases post-approval.
“Latera is an important development for nasal obstruction patients when a standard procedure treating the septum and turbinates is often not enough. Latera provides us with a minimally-invasive solution to support nasal Lateral cartilage. I was able to place the implant on my 1st attempt, and I expect that the physician learning curve will be short,” Dr. Pablo Stolovitzky of Emory University said in prepared remarks.
A multi-center study of the device, conducted in Germany, demonstrated that patients who received a Latera implant experienced a reduction in nasal obstruction symptoms at 1-year post procedure, without a reported cosmetic downside.
“Nasal obstruction takes a significant toll on patient quality of life, but is often undertreated and underdiagnosed. If we don’t look for nasal valve collapse in these patients, we’re not addressing the entire problem. By providing an intuitive and effective way to support nasal Lateral cartilage, Latera has the potential to improve breathing for our patients,” Dr. Dean Toriumi of Chicago’s University of Illinois said in a press release.
“We have worked with physician leaders to find a solution to a major clinical need. The research and development behind the innovation is complex, but the technique is elegant and intuitive. Latera gives physicians a new option to support Lateral cartilage, enabling a more complete means for addressing their patients’ nasal obstruction symptoms,” CEO Duke Rohlen said in a prepared statement.