Spirox Receives FDA Approval for Latera Absorbable Nasal Implant
Posted on July 15, 2016 by Medtech[y] Staff
Spirox announced FDA 510(k) approval for their Latera Absorbable Nasal Implant, which provides ENT's and facial plastic surgeons a minimally invasive option to support the upper and lower lateral nasal cartilages. When left untreated, lateral valve collapse is a major source of nasal obstruction.
The Menlo Park startup also announced the success of their first post-approval surgical case.
Pablo Stolovitzky MD, clinical assistant professor at Emory University and past chairman of the Board of Governors of the American Academy of Otolaryngology-Head & Neck Surgery (AAO-HNS), was among the first physicians to perform a LATERA case in the US. He noted, “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 first attempt, and I expect that the physician learning curve will be short.”
Prior to FDA 510(K) approval, a multi-center clinical study conducted in Germany showed that patients that received a LATERA implant alone experienced a reduction in nasal obstruction symptoms at one year, with results in the range of more invasive techniques and without a 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,” said Dean Toriumi, MD, professor of Otolaryngology-Head and Neck Surgery at the University of Illinois at Chicago, and past president of the American Academy of Facial Plastic and Reconstructive Surgeons (AAFPRS).
“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.
Spirox Latera IFU: