Spirox Announces First US Cases with Minimally Invasive Device for Lateral Cartilage Support in Patients with Nasal Valve Collapse, a Major Cause of Nasal Obstruction
July 14, 2016
MENLO PARK, Calif. – July 14, 2016 – Spirox™, Inc., a company committed to transforming treatment of nasal obstruction, today announced the first US cases with the LATERA™ Absorbable Nasal Implant following its FDA clearance. LATERA provides ENTs and facial plastic surgeons with a new minimally invasive option to support the upper and lower lateral nasal cartilages. Weak lateral cartilage can result in nasal valve collapse, an important, but often undiagnosed, issue affecting the majority of patients1 undergoing nasal obstruction procedures today.
“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).
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 (AAOHNS),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 these US cases, 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.
“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,” said Duke Rohlen, Spirox chief executive officer. “LATERA gives physicians a new option to support lateral cartilage, enabling a more complete means for addressing their patients’ nasal obstruction symptoms.”
About Nasal Airway Obstruction
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. The nasal valve contributes as much as 80 percent of total nasal airway resistance,2
and even minor constriction of this area results in a clinically significant impairment of nasal breathing for the patient.3 Nasal valvular incompetence may equal or even exceed septal deviation as the prime cause of nasal airway obstruction.
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 ENTs or facial plastic surgeons. For a complete list of safety and effectiveness considerations reference
the LATERA IFU at www.spiroxmed.com.