Spirox Shows Positive Results from Latera Implant Study in Nasal Valve Collapse Patients.
M2 PHARMA-September 21, 2016-Spirox Shows Positive Results from Latera Implant Study in Nasal Valve Collapse Patients
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- US-based medical device maker Spirox, Inc is showing positive results from a prospective, multi-centre study of the Latera Absorbable Nasal Implant, the company said.
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 or plastic surgeons.
According to Spirox, the study showed that the device provides a significant reduction in nasal obstruction symptoms in patients with nasal valve collapse and that early improvements were maintained through one year.
In the study, Latera showed 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% at one yea, 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.
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% of total nasal airway resistance, and even minor constriction of this area results in a clinically significant impairment of nasal breathing for the patient.4 Nasal valvular incompetence may equal or even exceed septal deviation as the prime cause of nasal airway obstruction.
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|Article Type:||Clinical report|
|Date:||Sep 21, 2016|
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